Express Pharma (Vol. 19, No. 6) May 2024

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Chairman of the Board

ViveckGoenka

Sr.Vice President-BPD

Neil Viegas

Vice President-BPD

Harit Mohanty

Editor Viveka Roychowdhury*

Editorial Team

Lakshmipriya Nair

Kalyani Sharma

DESIGN

Art Director

Pravin Temble

Senior Designer

Rekha Bisht

Senior Artist

Rakesh Sharma

Marketing Team

Rajesh Bhatkal

Ashish Rampure

Debnarayan Dutta

Production Co-ordinator

DhananjayNidre

Scheduling & Coordination

Pushkar Waralikar

CIRCULATION

Mohan Varadkar

CONTENTS

EVENTS

16 FDD CONCLAVE 2024 TO BE HELD IN JULY2024

16 EXPRESS PHARMA TO HOSTINAUGURALEDITION OF PHARMA& MED DEVICES SUPPLY CHAIN CONCLAVE IN MUMBAI THIS MAY

16 ANALYTICA ANACON INDIA& INDIALAB EXPO 2024 CONCLUDES SUCCESSFULLYIN MUMBAI

MARKET INTERVIEW

18 ASIA-PACIFIC FRONTLINE OFHEALTHCARE 2024

ANKITAMITTAL CEO,ENHANCED INNOVATIONS

Regd.With RNI No.MAHENG/2005/21398.Postal Regd.No.MCS/164/2022 - 24.Printed and Published byVaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press,Plot No.EL-208,TTC Industrial Area,Mahape,Navi Mumbai-400710 and Published at Mafatlal Centre,7th floor,Ramnath Goenka Marg,Nariman Point,Mumbai 400021.

Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Mafatlal Centre,7th floor,Ramnath Goenka Marg,Nariman Point,Mumbai 400021)

* Responsible for selection of news under the PRB Act.Copyright © 2017.The Indian Express (P) Ltd.All rights reserved throughout the world. Reproduction in anymanner,electronic or otherwise,in whole or in part,without prior written permission is prohibited.

Some action points for the next PM

The US has once again pulled up India for 'inadequate IP enforcement'. India is one of seven countries to remain on the Priority Watch List of the annual “Special 301 Report” recently released by the US Trade Representative (USTR). The other six countries on the Priority Watch List are Argentina, Chile, China, Indonesia, Russia, and Venezuela. The report warns that these countries will be 'the subject of particularly intense bilateral engagement during the coming year'.

The report concedes that while 'there has been progress under the US-India Trade Policy Forum in addressing certain issues with trademark infringement investigations and pregrant opposition proceedings, numerous long-standing concerns remain. These include inadequate IP enforcement, including high rates of online piracy, an extensive trademark opposition backlog, and insufficient legal means to protect trade secrets.' As per the report, among other things, India still needs to fully implement the WIPO Internet Treaties and to ensure that copyright statutory licenses do not extend to interactive transmissions.

The importance of the US market for India can be gauged by a report commissioned by the Department of Pharmaceuticals, according to which, as many as 24 blockbuster brands worth more than $250 billion (Rs 20.75 lakh crore) in annual sales have lost or will lose patent exclusivity in the US during this decade. India's generics manufacturers are gearing up to grab a piece of this pie. Indeed about half (seven) of the world's top 15 generics companies are Indian.

But it won't be a cakewalk for these seven major generic companies (Sun Pharma, Dr Reddy’s Laboratories, Lupin, Cipla, Aurobindo Pharma, Zydus Cadila and Torrent Pharma), as global competition is intense. Drug prices crash post-patent loss, due to this competition, which is good for patients but leaves drug makers struggling with thin profit margins. Adverse reports on India's good manufacturing practices, rumoured to be part of a campaign to discredit the sector, need to be addressed before they further impact the country's reputation as a source of quality, safe affordable medicines.

The report goes on to advise that India's pharma companies should invest more in developing capabilities to make generic copies of biologics (biogenerics), as more biologics are set to lose exclusivity in the period up to 2030. India's traditional strength lies in small molecule chemical-based drugs which is why not too many companies focus on biologics.

Biogenerics comes with higher risks, as the manufacturing process and technologies are more complex. The DoP report also points out that biogenerics need different approaches to deal with IP challenges.

In fact, another recent report must serve as a wake-up call for policymakers, led by the future Prime Minister, who need to make major course corrections to ensure that India’s pharma sector recovers lost ground.

Penned as an open letter to the PM and 'an earnest request to the powers that be to correct course and set India on its path to be a powerhouse for innovation', authors Nithya Balasubramanian, Director-Healthcare, Sanford Bernstein and Parth Shah, Equity Research Associate from the firm's healthcare team, contend that

As we vote in our next set of policymakers,a reality check shows that while the pharma sector in India has come a long way,‘there are still promises to keep’and ‘miles to go ...’

in healthcare, India is 'resting on past laurels'. The report cautions that 'from being the “Pharmacy of the World” and the "vaccine workshop of the world", India is slowly but surely ceding ground to its Asian peers in biopharma innovation and manufacturing.

The 17-page report acknowledges that ten of the top 20 generic companies in the US are Indian, and Indian companies command over 40 per cent Gx prescription shares. There is also a nod to India's vaccine dominance which came to prominence during the global COVID pandemic.

However, the authors mince no words when they point out that India is 'ceding ground to Asian peers', pointing out multiple areas where India lags behind Asian peers.

On the manufacturing front, the authors give examples of Chinese (Wuxi Biologics, Innovent, Beigene, etc) and Korean companies (Samsung Biologics, Celltrion, etc) which have invested in biomanufacturing capacities, leaving India far behind.

The authors believe that in biopharma innovation, China has emerged as a global biotech hub (~25 per cent of the global pipeline) with strong domestic talent and significant funding flowing in from investors and Big Pharma in the form of M&A and licensing. South Korea is also catching up with more biotech startups reaching global markets with their first drugs in the recent past.

Innovation, the authors claim, has been 'the orphan child' in India, as the country is not mentioned in the Healthcare Innovation index and does not feature in the top 10 patent publications in any health-related field.

Another fact is that among all the drugs under development, less than two per cent would be developed in India. And the reason is clear when you consider that for pharma companies the economics unfortunately don’t work today, as 'spending millions on clinical trials with no pricing power is not a business they want to be in.' A fact underlined by the largest pharma co in India chose not to market their marquee inn ovative asset in India so far, pointed out the authors.

Suggesting the 'pathway to a powerhouse for innovation' the authors recommend that 'India needs to create a domestic market where innovative drugs can hope to command the right price and enjoy profits.'

Other suggestions include government-provided insurance coverage for novel drugs, investing in core research talent, attracting quality talent back to India, easing the availability of funding for biotechs, and harmonising regulatory standards for manufacturing and clinical trials. They recommend that 'PLI schemes and other manufacturing sops need to be extended to more capital intensive biomanufacturing to level the playing field at least initially with Asian peers.'

As we vote in our next set of policymakers, these suggestions, and many more, underline the fact that while the pharma sector in India has come a long way, ‘there are still promises to keep’ and ‘miles to go ...’

VIVEKA ROYCHOWDHURY, Editor viveka.r@expressindia.com viveka.roy3@gmail.com

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EVENTS

FDD Conclave 2024 to be held in July2024

The seventh edition of this conference will be held in Hyderabad and gather FR&D leaders to discuss how India Pharma Inc can capitalise on its strengths such as technical expertise,cost efficiency,and supportive government policies in its next phase of growth and secure its position in the global pharma R&D landscape

Organised by Express Pharma, FDD Conclave has emerged as 'the' platform for leaders, experts and veterans of FR&D to come together confer and converse, on the current and future trends in the industry, their growth drivers and the challenges to tackle them as well as form meaningful alliances to fast-track progress.

This year, it will be held in July at Hyderabad. FDD Conclave 2024 will focus on the quest for more effective, targeted, and patient-friendly therapeutics, under the theme, ‘Forging the path for tomorrow’s therapeutics. The conclave aims to bring together ex-

Express

perts, researchers and thought leaders to explore novel approaches to FR&D and showcase capabilities to develop new molecules, innovative pharma/biopharma products.

The conclave will gather FR&D leaders to discuss how India Pharma Inc can capitalise on its strengths such as technical expertise, cost efficiency, and supportive government policies in its next phase of growth and secure its position in the global pharma R&D landscape.

They will also delve into the advancements, challenges and opportunities in formulation development and drug delivery driven by technological innova-

tion and evolving patient needs.

Topics to be covered

◆ Cutting-edge formulation strategies (Nanotechnology, biopharma and biosimilars, complex generics, specialty drugs, controlled release formulations etc)

◆ Innovative drug delivery systems (Microneedles, implants, prefilled syringes, self-administered drug delivery systems, transdermal patches etc)

◆ Windows of opportunities to accelerate the development and commercialisation of next gen therapeutics

◆ Barriers and challenges such as bioavailability enhancement, solubility issues, stability chal-

lenges, excipient selection, lab to market scalability, regulatory approvals etc

◆ Emerging technologies and their applications in FR&D Approaches to build a more cohesive and collaborative ecosystem between academia, industry and regulatory agencies

◆ Patient-centric design for formulation and delivery to improve therapeutic outcomes Thus, FDD Conclave 2024 will facilitate progress in the FR&D and contribute through creation of intellectual property, development of novel solutions to address unmet medical needs, enhancement of patient care.

Stay tuned for more details!

Pharma to host inaugural edition of Pharma & Med Devices SupplyChain Conclave in Mumbai this May

Under the compelling theme,"Supply chains of tomorrow: Secure,smart, sustainable",the event seeks to be a platform for industry leaders and experts to explore strategies and technologies to build and maintain resilient, secure,and sustainable supply chains for pharma and medical device sectors

Express

Pharma is organising the inaugural edition of Pharma & Med Devices Supply Chain Conclave, scheduled to take place on May 10, 2024 at Courtyard by Marriott, Mumbai. Leaders and experts from supply chain, procurement and logistics will convene to explore the future of supply chain management in the pharma and medical device sectors at this conference

Under the compelling theme, "Supply chains of tomorrow: Secure, smart, sustainable", the event seeks to be a platform for industry leaders and experts to

explore strategies and technologies to build and maintain resilient, secure, and sustainable supply chains for pharma and medical device sectors.

It presents a great opportunity for supply chain professionals from the pharma and med devices sector to network with peers, gain valuable insights, and contribute to shaping the future of supply chain management in healthcare.

Keypanel discussions

◆ Supply chains of tomorrow: Secure, smart, sustainable

◆ Decoding the dynamics of

medical devices supply chain

◆ From fragile to agile: Building resilience in pharma supply chain the face of disruptions

From cutting-edge technologies to sustainable practices and resilience strategies, the Conclave covers it all.

Whyattend?

◆ Gain insights from top industry experts on navigating challenges and seizing opportunities in pharmaceutical and medical device supply chains.

◆ Network with peers and

forge valuable connections that could propel your career or business to new heights.

◆ Discover innova tive solutions and strategies to optimize your supply chain operations for maximum efficiency and effectiveness. Don't miss out on this opportunity to be part of the conversation shaping the future of supply chain management in pharma and med devices!

Reserve your spot today! Register Now! https://t.ly/10sccT

analytica Anacon India & India Lab Expo 2024 concludes successfullyin Mumbai

The recent Mumbai edition of analytica Anacon India and India Lab Expo, organised jointly by Messe Muenchen India and the Indian Analytical Instruments Association (IAIA), concluded successfully. It comprised technical conferences, hosted buyer programme, prefixed buyer- seller meetings, and much more. Reportedly, the event saw a 63.5 per cent growth in exhibition space over last year. This platform brought together 165 brands displaying 3000 products covering analysis and laboratory equipment, diagnostics technologies, biotech solutions, and instruments for quality control, measurements, and testing. It had a visitor footfall of over 6024 trade visitors from key user industries such as food and pharma, healthcare and diagnostics, chemicals, cosmetics, research institutions, amongst many others.

Some of the leading exhibitors at this edition are Kewaunee Labway India, Agilent Technologies India, Shimadzu Analytical (India), Newtronic Lifecare Equipment, Labguard India, and many others. Certifications and regulatory authorities who participated in exhibition and conferences are Food and Drug Control Administration (FDCA), Indian Pharmacopoeia Commission (IPC), United States Pharmacopeia (USP), National Accreditation Board for Testing and Calibration Laboratories (NABL), and many others. The next edition of analytica Anacon India/India Lab Expo will be held on September 26-28, 2024 at HITEX, Hyderabad, co-located with Pharma Pro & Pack Expo. For press and media enquiries, contact Ayurshi Chaudhary at ayurshi.chaudhary@mmindia.in

MARKET

Asia-Pacific Front Line of Healthcare 2024: Bain & CompanyReport

Bain &Company’s recent report reveals that Asia-Pacific will be the fastest-growing region in healthcare spending,accounting for more than 20 per cent of global spending by 2030.However, access to care,cost,and quality remain critical challenges for healthcare systems

To understand opportunities and challenges in the evolving Asia-Pacific healthcare landscape, Bain & Company conducted a survey in Q4 2023 to uncover consumer-centric trends in healthcare consumption.

The survey was distributed to 2,300 consumers across nine Asia-Pacific geographies (Australia, China, Hong Kong, India, Indonesia, Malaysia, Philippines, Singapore, and Vietnam) in a process similar to the data collections we conducted previously in 2019 and 2021.

Taken independently or in comparison to our earlier AsiaPacific Front Line of Healthcare Reports, the most recent results help us understand how Asia-Pacific consumers’ healthcare behaviors and preferences have changed and provide key insights into emerging trends in the region:

1. Healthcare is no longer a passive experience : Consumers are taking charge of their health, are demanding a better experience, and are willing to invest in wellness.

2. The future of healthcare is everywhere : Consumers expect seamless, omnichannel care experiences that extend beyond traditional hospital settings.

3.Integrated care will become the new standard : Consumers demand a single touchpoint to manage their health and are open to new specialty care models and curated customer journeys.

4. The tech revolution is transforming healthcare: AI and health tech are unlocking the power of personalised care and reinventing how we deliver healthcare.

As these four trends shape healthcare delivery in the region, companies have four strategic opportunities to

Figure1: Consumersareproactivelymanagingtheirhealthandwell-being

Percentageofrespondentsagreeingtothestatements (2023)

Ihaveaninterestin healthmaintenanceand lifestylechanges

Iexpect convenience inadditiontoquality

Ido moreresearchonline tounderstandmysymptomsand treatments

Iammore informedabout mydisease andtreatmentoptions

Iaminterestedinthe lowest costalternativeforaparticular treatment

Notes:Respondentswereaskedthequestion,“Comparedtothreeyearsago,towhatextentarethefollowingstatementsaboutyoutruetoday?”;Percentages includethosewhoresponded“mostlytrue”or“somewhattrue”tothequestion

Source:BainFrontLineofHealthcareAsia-Pacificsurvey,2021(n=1750),2023(n=2300)

Figure2: Astrongdesiretoinvestinproactiveandpreventivecarethroughnutritionandsupplement spending

Percentageofrespondentslikelytospendmoreinnext12months

traditionalmedicine

Notes:Respondentswereaskedthequestion“Howhaveyourspendinghabitschangedoverthepast12monthsversustheyearpriorinthefollowingconsumer healthcategories?”and“Howdoyouexpectyourspendinghabitstochangeoverthenext12monthsversusthepastyearinthefollowingconsumerhealth categories?”

Source:BainFrontLineofHealthcareAsia-Pacificsurvey,2023(n=2300)

attract consumers and improve public health:

1. Reinvent customer experience: Prioritise patientcentered care to deliver personalised recommendations and a seamless omnichannel experience for enhancing outcomes and satisfaction.

2. Coordinate care delivery: Upgrade care management through better collaboration and coordination across

care teams.

3. Future-proof technology infrastructure : Digitise legacy processes and use innovative technologies to empower healthcare providers and consumers.

4. Forge strategic partnerships: Connect care journeys across the broader healthcare ecosystem of partners and break transactional silos.

Keythemes

Consumerism: Consumers across Asia-Pacific are taking a proactive approach to managing their health, fitness, and overall wellness. As a result, an increasing share of consumers are expressing interest in health and lifestyle maintenance and are following through with timely check-ups to take control of their wellbeing.

Consumer-driven health monitoring (e.g., sleep tracking, heart rate monitoring) has increased in the region due to the emergence of increasingly affordable smart wearables, including watches and bands. Brands like Noise in India now provide smartwatches at just $10 to $12, democratising wearable access. As a result, in our 2023 survey, roughly 85 per cent of respondents expressed interest in health maintenance and lifestyle changes.

Consumers in Asia-Pacific also increasingly expect greater convenience in healthcare delivery. They actively seek healthcare providers and services that are more accessible, flexible, and tailored to their specific needs (see Fig 1).

Consumers are increasingly willing to spend more on healthcare. According to 2023 survey results, 51 per cent of Asia-Pacific consumers (58 per cent of Gen Z) say they are willing to pay more out of pocket for healthcare in exchange for better health outcomes, better experiences, and greater efficiency.

The adoption of wellness trends, however, is more common among the “healthy and wealthy” group.

In high-income groups, 50 per cent reported spending more on nutritional supplements, compared to the overall population at 45 per cent. Gen Z exhibits more active involvement in their healthcare compared to other age cohorts, with higher healthcare spending. According to our survey, the Gen Z population is especially focused on preventive products and services in the consumer health category, with a notable surge in demand for nutrition products such as vitamins and supplements (see Fig 2).

Care everywhere: The old

MARKET

notion of hospitals as the sole preferred or preeminent healthcare providers is slowly shifting across the Asia-Pacific region thanks to technological intervention, sustained focus on convenience, and a surge in consumerism.

Today’s patients want to explore care options that are both convenient and affordable. Accessible healthcare options—including wellness support and other non-acute care services—are becoming increasingly available at community clinics, pharmacies, and other non-hospital locations across the region.

Compared to our 2021 results, consumers exhibit greater comfort in 2023 about receiving care outside conventional hospital setups, particularly for routine check-ups and diagnostic services (see Fig 3).

During the pandemic, many consumers received Covid-19 testing and vaccines at pharmacies, helping to normalise the notion that such places could serve as a point-of-care provider. As a result of these experiences, consumers are becoming more comfortable with accessing healthcare services at pharmacies. In fact, 2023 results suggest that at least 65 per cent of consumers (74 per cent in Gen Z) use pharmacies as a primary point of care.

The survey also suggests that in the future, the proportion of consumers willing to seek pharmacy provided healthcare may increase to 73 per cent (82 per cent in Gen Z) in the presence of partnerships between pharmacies and other healthcare providers, including clinics or specialists. Our results found that between 70 per cent of consumers in Malaysia, the Philippines, and Vietnam and 85 per cent of consumers in China, India, and Indonesia are willing to consider pharmacies as their primary healthcare providers when partnerships with other healthcare providers are in place.

Based on our 2023 survey, we anticipate a significant increase in the adoption of pharmacy-provided services such as diagnostic services, health

Figure3: Careisextendingbeyondtraditionalhospitalsettings

Percentageofrespondentscomfortable*receivingcareoutofhospital

Notes:Respondentswereaskedthequestion,“Howcomfortablewouldyoufeelaboutgettingcareforthefollowingservicesawayfromatraditionalhospitalset-up (e.g.,atambulatorysurgerycenters(ASCs),retailclinics,homeservices)?

(*)Percentageofpatientsincludethosewhoresponded,“somewhatcomfortable”and“completelycomfortable”forservicesmovingoutsidethehospital;Imaging includesx-rays,ultrasounds,etc.;Healthcheck-upsincluderoutineandpreventivecheck-ups;Pathologyincludesbloodtests,etc.;Follow-upconsultations includepost-surgeryoracutecareepisodes;Cancercareincludesregularchemotherapysessions.MalaysiaandthePhilippineswerenotcoveredinthe2019 survey.VietnamandHongKongwerenotpartofthe2019and2021surveys

Source:BainFrontLineofHealthcareAsia-Pacificsurvey,2019(n=1823),2021(n=1750),2023(n=2300)

Figure4: Potentialforapharmacytotransformintoahealthcarepartner

Percentageofrespondentsthatarelikelytouseservicesatpharmacyinthenexttwoyears

Note:Respondentswereaskedthequestion,“Whatserviceshaveyouutilizedatyourpharmacy/healthcareretailerinthepast12months,andwhatservicesare youlikelytouse(ifmadeavailable)inthenexttwoyears?”

Source:BainFrontLineofHealthcareAsia-Pacificsurvey,2023(n=2300)

Figure5: Telemedicineisheretostaypost-pandemic

Percentageofrespondentswhousedtelemedicineservicesinthepast12months

Notes:Respondentswereaskedabouttelehealthusageinthepast12monthsacrossthe2019,2021,and2023APACFLoHSurvey.GrowthΔhasadeviationof+/-1%dueto roundingoff;MalaysiaandthePhilippineswerenotcoveredinthe2019survey.(*)VietnamandHongKongwerenotpartofthe2019and2021surveys

Source:BainFrontLineofHealthcareAsia-Pacificsurvey,2019(n=1823),2021(n=1750),2023(n=2300)

screenings, home delivery of medicine, and medication therapy management for chronic illnesses such as hypertension and diabetes (see Fig 4)

Our earlier surveys pinpointed a huge leap in telehealth adoption, which nearly doubled between 2019 and 2021 across Asia-Pacific. In this year’s survey, we observed post-Covid telehealth penetration growth slowing yet persisting across Asia-Pacific markets (see Fig 5).

The benefit of telehealth is evident, especially in lowering healthcare costs. This is primarily attributed to the early triage and steerage to right side of care coupled with the low price point and pharmacy attach rate for teleconsultation compared to in-person primary consultation. For example, according to Halodoc, a telehealth and e-pharmacy platform in Indonesia, the overall cost of telemedicine (including consultation and medication) is three times cheaper than offline mode (see Fig 6).

In addition to being cost-effective, online consultations demonstrated a high-solve rate of more than 95 per cent for the top five online diagnoses (e.g., acute upper respiratory tract infections, nasopharyngitis, fever).

In response to the new digital norms, offline heritage healthcare providers are also doubling down on digital capabilities. In India and Indonesia, provider-owned apps from longtime healthcare players have nearly tripled their active monthly users in the past three years. For example, Indiabased provider Apollo Hospitals has worked to boost its digital services by launching its Apollo 24|7 app, where consumers can access services like video consultations, hospital appointment booking, and at-home medication and diagnostics ordering, all in one place. The hospital network has also expanded access to omnichannel care through its presence across a wide network of hospitals, clinics, diagnostics centers, and pharmacies, enhancing consumer experience and convenience.

Care management: Primary

care is making a comeback post-pandemic: 91 per cent of consumers prefer a single touchpoint to manage their health. Following trends evident in our survey findings, we continue to see strong consumer interest in a single, accessible touchpoint to manage their care.

In most markets where the primary care system is already established, digital health is not displacing primary care but supercharging its effectiveness.

A key exception is China, where digital health is helping reshape consumers’ care delivery preferences. There, 62 per cent of respondents report preferring a virtual touchpoint of care—a trend that has, no doubt, been driven by lower accessibility to independent clinics and long wait times at hospitals (see Fig 7).

Consumers want a single touchpoint to manage their health. Who do they trust to manage and coordinate their overall healthcare needs? Primary care providers remain most trusted across many Asia-Pacific markets for managing overall healthcare needs. In China, Indonesia, and Vietnam, where there is a significant gap in the availability and quality of primary care services, consumers trust hospitals the most. We’ve also observed recent trends hinting at additional trust in non-traditional delivery channels, including retail health outlets and digital-first players, with consumers in India and Malaysia displaying high trust in pharmacies.

Roughly 70 per cent of consumers in India, Indonesia, and China affirmed trust in digital health and tech companies to manage their healthcare needs. Meanwhile, offline providers still hold a roughly 40 per cent trust advantage over digital players in Australia, Singapore, Malaysia, and the Philippines (see Fig 8).

Our 2023 survey results also show that consumers seek integrated care pathways, especially in managing chronic conditions. Respondents highlighted the lack of affordable, accessible care and long waiting times at providers as key

obstacles in their search for chronic care management.

Many respondents noted a lack of adequate patient information or clarity on their care journey as other roadblocks to their care success.

As a result, new care models are emerging to address these concerns by delivering

end-to-end integrated care delivery, bringing more affordable, accessible, and curated care to patients.

Additionally, players are enhancing capabilities and engaging in partnerships to provide integrated care to patients. For example, Singapore-based firm Doctor Any-

where, which specialises in telemedicine and other digital health services, acquired Asian Healthcare Specialists with 12 specialist clinics providing multidisciplinary services (e.g., orthopedics, ophthalmology).

This strategic integration aims to enhance consumer access to secondary care services, pro-

moting a seamless integration between online and offline services.

Today’s consumers expect payers to take an involved, guiding role in their healthcare journey.

Roughly 80 per cent of consumers look to insurance partners for specialist,

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diagnostician, or primary care provider recommendations. Consumers are also increasingly using insurance-backed digital apps, with roughly 50% penetration for services like online appointment booking, self-diagnosis, and digital claim management and is expected to rise to 70% per cent in the next two years.

At the same time, healthcare-related claims costs are rising, with an expected 12 per cent year-on-year increase in Asia-Pacific geography. For example, in Indonesia, as per Halodoc, women are more likely to see outpatient doctors compared to men but spend less on average for inpatient services. The Halodoc report also indicated that the offline outpatient and inpatient claim costs for older members were roughly six times higher (see Fig 9)

As consumers’ expectations change and healthcare claim costs rise, a new archetype of healthcare stakeholders has emerged: health insurers that manage patients’ health and wellness by enabling medical care. These “medicalised payers” offer more patient-centric care by integrating primary to specialty care services, coordinating care across providers and facilities, and improving health outcomes while reducing costs. Major insurers collaborate with healthcare players and digital insurgents, guiding customers in navigating their patient care journey.

Across Asia-Pacific, leading life insurance companies like AIA Group and Prudential are investing significantly in health to build capabilities for coordinated care. For example, Prudential announced its “Transforming Health Business Model” as one of its three strategic pillars and is upgrading health insurance capabilities through advanced products and value-added services like personalised wellness services.

AIA partnered with Amcal and Guardian pharmacies in Australia in 2021 to provide its members with in-store screening services from these pharmacies. In partnership with

Figure6: TelemedicineisthreetimescheaperthanofflineconsultationinIndonesia,asperHalodoc data

Approvedamountforonlinevs.offlineconsultationsandmedicationsfortop5diagnosesforHalodoc memberbase(inUSD),2022

May2024

Note:Exchangerateusedis1IndonesianRupiah=0.000064536106USD(asofDecember2023)

Source:Halodocreport,2022

Figure7: Consumersprefersingletouchpointtomanagehealthcareneeds

Percentageofrespondentspreferring singletouchpoints

Percentageofrespondentspreferring virtualtouchpoint

Notes:Respondentswereasked,“Whichofthefollowingstatementsbestdescribesyourchoiceofinteractionwithhealthcarechannels?–a)Preferto

gotoaclinic/healthcenterinperson;b)Prefertousemysmartdeviceasasingletouchpoint;c)Prefertohaveasinglehotlineasafirstpointofcall; d)Preferto findmydoctorsandotherhealthcarespecialists”;Respondentswhoselectedoptionsa,b,andcprefersingletouchpoint,whilevirtualtouchpoints includeoptions bandc;MalaysiaandPhilippinesnotcoveredin2019survey.VietnamandHongKongwerenotpartofthe2019and2021surveys Source:BainFrontLineofHealthcareAsia-Pacificsurvey,2019(n=1823),2021(n=1750),2023(n=2300)

Figure8: Patientstrusttraditionalcareprovidersbutaregainingconfidenceinpharmaciesandtech companies

Discovery Group, AIA launched “Amplify Health” in February 2022 to improve patient access to the right providers, enabling better care coordination based on patientspecific health risks. In January 2023, Amplify Health acquired AiDA Technologies, whose AI-powered suite aids in claims management through automatic fraud detection, data-driven claims processing, and underwriting, reducing service costs and improving operational efficiency for businesses.

Tech revolution

The Asia-Pacific region is overhauling its healthcare systems, owing to the significant healthcare gaps in emerging Asian markets. These gaps include the burden of disease, demographic transition, limited social health protection, supply constraints with low doctorpatient ratios, and overburdened traditional healthcare channels. To overcome these gaps, healthcare stakeholders have to adopt an open mindset to integrate technology applications, disrupting traditional delivery models to deliver consumer-centric care. Prominent health tech use cases include the rise of connected care systems for real-time monitoring, genomics for personalized treatments, augmented/virtual reality for medical training and patient engagement, and robotics plus automated systems to enhance patient experience. Each of these technologies is driving significant shifts in patient care delivery. Technological advances are shifting care expectations from a consumer perspective. Consumers are increasingly embracing smart wearables, so players now have access to a wide range of personal health data, opening the door to more targeted, personalized care in the future.

Notes:Respondentswereasked,”Howmuchdoyoutrustthefollowingtomanageyouroverallhealthcareandcoordinateyourtreatmentwithotherhealthcare providersinyourcountry?”Percentageofrespondentsincludethosewhoresponded“somewhattrust”or“completelytrust”tothequestion;(*)Vietnamand HongKongwerenotpartofthe2021survey

Source:BainFrontLineofHealthcareAsia-Pacificsurvey,2021(n=1750),2023(n=2300)

State-of-the-art remote patient monitoring devices also shift care delivery by enabling accurate, realtime health monitoring for patients with chronic conditions such as heart disease and diabetes. Many providers now prescribe continuous glucose monitoring

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patches for diabetes management or continuous electrocardiogram smart patches for heart patients.

Health tech’s rising status as a key care delivery module will undoubtedly spur future partnerships between tech companies and healthcare players to pursue more effective, personalised care devices.

Pharma and medtech players are already starting to engage with patients directly, leveraging digital health and smart devices for chronic disease management.

For example, AstraZeneca partnered with Adherium Limited to offer a mobile-based smart inhaler linked to a digital portal that tracks medication dosage and enables data sharing with physicians. The goal is for patients to properly adhere to prescription guidance, achieving better patient health outcomes.

Similarly, M-Wear, a health wearable by Mindray, provides real-time patient health tracking for post-surgery or chronic care cases, providing doctors with reliable, real-time patient data and alerts if acute care intervention is warranted.

Among these technologies, AI-backed devices are netting distinctive investor traction, with reported cumulative deals of $9 billion in 2021 across the region. According to an analysis using Crunchbase data, China ($970 million) and Hong Kong ($250 million) boasted the highest funding, while Indian start-ups offering AI-driven health solutions recorded deals valued at $60 million. Clinical decision support and drug discovery use cases received the most investment funding between 2015 and 2022.

Consumers are also embracing AI in healthcare for enhanced access and better outcomes. According to our 2023 survey, more than 50 per cent of respondents now feel comfortable with AI-powered healthcare delivery—including care delivery through AI only and healthcare providers powered by AI—for preventive and wellness care and less severe physical conditions (see Fig 10).

However, for more severe

or urgent physical conditions

(e.g., persistent chest pain, coughing blood), 70 per cent of consumers prefer to receive care through human healthcare providers only.

There has been a significant increase in healthcare technology adoption in the Asia-Pacific region over the

past few years. Compared to 2019, only 22 per cent of respondents in Asia-Pacific used telehealth services that involved a human doctor at the other end of the virtual platform; in 2023, over 50 per cent of respondents are open to having AI as a facilitator in their healthcare delivery, par-

ticularly for p reventive care and less severe physical conditions, demonstrating the substantial optimistic sentiment consumers now have toward the use of technology, especially AI.

Furthermore, in an environment where medical professionals are scarce, AI applica-

tions and technologies reinvent how care is delivered by supporting physicians’ abilities to make better clinical decisions and automating and streamlining hospital administrative tasks. Providers across the Asia-Pacific region are actively ideating and fine-tuning AI-powered tools for enhanced

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productivity, cost-effectiveness, and superior patient outcomes.

For example, India-based start-up Qure.ai aims to innovate radiology imaging analysis through AI-powered, automated clinical decision support tools. Their imaging solutions cover a range of specialties, with highly accurate image processing (over 90 per cent) and reduced turnaround time (less than 20 seconds processing time for orthopedic scans) compared to traditional methods.

Strategic opportunities

Asia-Pacific healthcare continues to undergo dramatic shifts in consumer demand, technological integration, and available care delivery modules. To appropriately capitalise on both existing and forecasted trends, Asia-Pacific healthcare companies can focus on four key opportunities:

1. Reinvent customer experience: Most Asia-Pacific patients prefer a single touchpoint to manage their healthcare needs. While face-to-face interactions are more commonly preferred, the pandemic has increased acceptance of virtual touchpoints. Therefore, healthcare providers must strike the right balance between online and offline interactions throughout the patient care journey. Digital transformation involves seamlessly integrating online and offline experiences, embedding digital tools and processes, and connecting important workflows. With the help of technology, healthcare professionals can collaborate more effectively and provide patients with a seamless omnichannel experience.

Healthcare players should stay attuned to evolving consumer needs, including increasing demands for wellmapped, easy-to-navigate customer health journeys. Further, they should deploy mechanisms, such as Net Promoter ScoreSM, to measure their customers’ experience and demand for particular services. This will enable providers to effectively re-evaluate and re-design their services and

Figure9: InIndonesia,inpatientclaimcostsarehigherforolderandmalemembers,asperHalodoc data

AverageclaimamountforIPandOfflineOP pertotalmemberbyagegroup(inUSD),2022

AverageclaimamountforIPandOfflineOP pertotalmemberbygender(inUSD),2022

Notes:OP=outpatient;IP=inpatient;Exchangerateusedis1.0IndonesianRupiah=0.000064536106USD(asofDecember2023)

Source:Halodocreport,2022

Figure10: AIispoisedtoplayalargerroleinsupportinghealthcaredecisions

PercentageofrespondentscomfortablewithAI-backeddecisionsupportacrossusecases

May2024

(e.g.,fitnessworkouts,nutrition plans,curateddiets/vitamin supplementsbasedonmedical condition)

(e.g.,persistentcough,testsfor persistentstomachache,treatment forfoodpoisoning)

(e.g.,dealingwithanxiety, stress,depression)

(e.g.,persistentchestpain, coughingblood)

Notes:Respondentswereasked,“Aspatients,whichofthefollowingdeliveryformatsdoyoufindmostsuitableforvarioushealthcareneeds?”;23responses excludedwhereoptedforseverephysicalconditionandnotpreventive

Source:BainFrontLineofHealthcareAsia-Pacificsurvey,2023(n=2300)

delivery modules to match consumer preferences.

Additionally, healthcare players could look to tailor or curate services for targeted cohorts of patients. Awareness of demographic preferences— for example, Gen Z’s greater usage of nutritional care—can help shape providers’ customised offerings. This approach requires increased focus on need-based segmentation, personalised care, and tailored recommendations that match individual consumers’ needs to capitalise on current consumer trends.

2. Coordinate care delivery: As rising claim costs deeply impact payers, insurance providers should look for ways to integrate patient care management more effectively toward better care delivery. When payers play a greater role in patient steerage and guidance, they can help limit the need and associated costs of more severe diagnoses and treatments.

Specifically, to achieve better health outcomes and more optimised costs, payers could play a proactive role in providing care guidance through services such as medical concierges and preferred panels. Payers can also focus on mapping the customer journey and identifying areas for intervention to assess different care managment needs for the member population segment. This could be followed by designing an optimal operating model that meets business needs and customer expectations.

Additionally, payers can’t do everything simultaneously and need to thoughtfully prioritize efforts where they can be only “good enough” vs. where they can create “delight” across the member segments. Additionally, retail pharmacies could benefit from patients’ growing willingness to seek primary care services outside of conventional setups by extending their capabilities across additional service offerings. Pharmacies might build capabilities in-house and partner with other providers to deliver a suite of service offerings, including diagnostics,

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consultations, medication management, and more.

3. Future-proof technology infrastructure: Healthcare incumbents should look to digitise legacy processes and ensure front-end digital interface integration if they hope to maintain relevance in the modern healthcare market’s growing omnichannel delivery ecosystem.

The digitisation of existing healthcare systems can increase efficiency and productivity gains for healthcare providers. This includes integrating more efficient patient record management, databacked health insights, and clinical decision support tools.

The emergence of new technologies, such as robotics, AR/VR for workforce training, and generative AI for improving diagnosis and bringing efficiencies in admin processes, can further empower health-

Awareness of demographic preferences—for example,Gen Z’s greater usage of nutritional care—can help shape providers’customised offerings.This approach requires increased focus on need-based segmentation,personalised care, and tailored recommendations that match individual consumers’needs to capitalise on current consumer trends

care delivery improvements across the Asia-Pacific region.

Healthcare systems are already widely using these tools to mitigate challenges due to staffing shortages without compromising care quality.

One example is Apollo Hospitals in India, which has utilised Google Cloud’s Vertex AI and generative AI models to

develop a Clinical Intelligence Engine tool as a clinical decision support system for doctors.

Finally, companies can concentrate on providing the necessary tools to further enable consumers to take control of their healthcare. Consumers are increasingly comfortable using smart wearables and

digital apps for regular health monitoring. Players should leverage these emerging trends and equip consumers with innovative technology solutions to forge stronger connections between patients and healthcare providers, ensuring a more comprehensive and patient-centric approach to healthcare.

4. Forge strategic partnerships: With the growing traction for convenience-led integrated care points, healthcare players may wish to establish a presence across the entire care continuum. This goal will require building new capabilities and skills.

As these shifts occur, the Asia-Pacific healthcare sector will likely witness strategic partnerships across delivery formats and player archetypes—for example, between payer-backed providers, pharmacies powered by specialty clinics offering “one-stop shop” solutions, and pharma and medtech companies leveraging tech capabilities for better patient engagement.

Digital insurgents’ partnerships with incumbents could make for an interesting play as they offer superior digital capabilities while benefiting from the legacy player’s trusted brand and scale advantages.

INTERVIEW

Phloton has been developed for the remotest, most extreme geographies of not onlyIndia but the entire developing world

Enhanced Innovations,a company backed by BIRAC-KIITBhubaneswar and Social Alpha,has launched Phloton,a device that can address the critical issue of vaccine wastage and improve last-mile healthcare delivery. Ankita Mittal ,CEO,Enhanced Innovations,shares more details about Phloton,and its applications and impact on immunisation,medication and diagnostics delivery,in an interview with Lakshmipriya

What is Phloton and how does it work to address the challenges faced in last-mile healthcare delivery?

Phloton is a portable, active cooling device that can be used to strengthen point-ofcare services for immunisation, medication and diagnostics delivery. It can help in transporting temperature sensitive vaccines, medicines and diagnostics samples safely while maintaining the required temperature.

In India alone, we have 91 districts where less than 50 per cent of children are fully immunised against preventable life-threatening diseases. In addition to this, India is also home to almost four crore pregnant women and newborn children who have not been fully immunised. This is despite intense efforts by the government through far reaching and critical programs on immunisation. The situation is similar across other developing countries as well. WHO estimates say that globally, 50 per cent of all temperature sensitive vaccines manufactured go to waste.

There are many reasons that have contributed to this landscape, and two important factors are insufficient lastmile cold chain capacity and inadequate temperature monitoring. These gaps lead to vaccine spoilage leading to women and children getting

Nair

Our product is uniquely positioned to attract institutional investors with deep impact in the pharma sector, where two-third of all new therapeutic interventions have biologics or active ingredients which require cold chain transportation

no or ineffective immunisation.

Phloton has been developed to address these critical gaps by ensuring temperature sensitive vaccines are stored and transported safely while maintaining the required temperature. The Phloton device itself is designed to be easy to handle for frontline health care providers.

How does Phloton differentiate itself from existing solutions/services in the market?

Phloton is an active cooling solution which makes it more effective and reliable as a cold chain solution for vaccines, medication and diagnostics storage and transportation.

An example of this differentiation is that at an ambient temperature of 35 deg Celsius, the ice-packs that are traditionally used to store and transport vaccines, lose 50 per cent of their coldness within 60 minutes. This makes them an unreliable storage mechanism for temperature sensitive vaccines, medicines and diagnostics.

Through Phloton, we are able to address these problems by maintaining a chamber temperature of 4 deg Celsius or lower in ambient temperatures ranging between -20 deg Celsius and 65 deg Celsius for at least 10 hours, depending on the ambient temperature. The device is currently equipped

to carry up to 60 vials in its 2 litre chamber which can be scaled up to 50 litres. This makes its application to all aspects of the healthcare cold chain easy – especially with its simple plug and play modality.

What are the technologies or innovations that Phloton uses to address the issue of vaccine potency loss during transportation and storage?

Phloton relies on active cooling to maintain temperatures and as a result, vaccine potency. Other key innovative features of the Phloton system are highlighted here:

◆ Phloton uses IoT/AI-ML to improve system performance with real time updates to improve battery efficiency –its centralised cloud based repository ensures that every vaccine vial is delivered with no loss to efficacy due to lastmile cold chain gaps, which we know contributes to greater than 50 per cent vaccine losses.

◆ Phloton utilises a high performance insulating material with lowest thermal resistance to isolate the vaccine chamber from conduction, convection and radiation based heating.

◆ An example of this is that Phloton is designed to keep vials/bottles at a very precise temperature. The insulation system in Phloton is effective enough to maintain its chamber temperature for an extra 4 hours after the cooling

system shuts down, before the inside temperature gets above 8°C. This is the threshold safe temperature after which vaccines start losing their efficacy at an exponential rate.

◆ Phloton has been developed for the remotest, most extreme geographies of not only India but the entire developing world – designed to reduce the burden on the existing ecosystem in such low resource settings. Phloton has an integrated solar panel module which can easily charge the Phloton device in the absence of grid power –ensuring that the device does not solely rely on external or non-renewable power sources.

◆ In addition to the solar panels, Phloton also offers a high positive environmental impact as the device system does not use any refrigerants which are currently used to cool ice packs. These

refrigerants contribute 2000 times more to global warming as compared to carbon dioxide.

◆ Phloton system is already in touch with several drone manufacturing organisations for transport of biologics through air.

What is the role of BIRACKIIT Bhubaneswar and Social Alpha in supporting and backing in this venture?

Any plans for future investment rounds to support the growth and expansion of Enhanced Innovations and Phloton?

◆ Social Alpha was the first to support our vision to build a robust last mile cold chain using green technology. We have leveraged Social Alpha’s network of engineering and academic support to develop the Phloton prototype.

◆ KIIT-TBI supported our

vision for Phloton by giving us the opportunity to apply for schemes such as MEITY TIDE and BIRAC SEED.

There is an intent to further the development and utilisation of Phloton through investments in the future. Our product is uniquely positioned to attract institutional investors with deep impact in the pharma sector, where two-third of all new therapeutic interventions have biologics or active ingredients which require cold chain transportation. Even the Universal Immunisation Program is expanding to increase vaccines from the mandated 11 interventions to more in the coming future for example HPV, HEP-B etc. – and Phloton is an apt partner for this expansion

Can you share any successful case studies that showcase the effectiveness

of Phloton's services?

◆ We have worked with several foundations such as Selco to support animal vaccination programs.

◆ Additionally, Phloton was tested by the Akshaykalpa Foundation in Karnataka to address animal vaccine spoilage – it proved effective in maintaining vaccine temperatures in a real-world deployment scenario.

◆ FaunaTech Solutions is a quantitative milk assessment company – they deployed Phloton to safely transport milk samples for assessment. The company reported a positive experience with Phloton in Bangalore Rural’s milk cooperatives with Phloton demonstrating efficiency in sample collection and reliable temperature control, which is vital for accurate analysis.

◆ Other Phloton active

deployment case studies are currently ongoing at URMUL (Rajasthan), NDRI (Haryana), Vivekananda Youth Movement Hospital (Karnataka) and KRYSPR (Karnataka)

What partnerships or collaborations are in the offing to scale and expand the reach of Phloton's services?

◆ Phloton is working with veterinary institutes to transport vaccines and blood samples to mitigate the spread of infection borne diseases.

◆ Phloton has received working orders from several hospitals across India including a leading eye care chain in West Bengal to transport critical biologics across their hospital network.

lakshmipriya.nair@expressindia.com laxmipriyanair@gmail.com

Ahmedabad Pharma Summit 2024 brought industry thought leaders together to chart the course for innovation and growth in India's pharma landscape

Panel Discussion: WhyAhmedabad is a go-to destination for pharma manufacturing?

(L-R) SG Belapure,Sr Technical Advisor,IPA(Moderator); RajivGandhi,CEO & MD,Hester Pharmaceuticals; Dr Viranchi Shah,National President,Indian Drug Manufacturers Association (IDMA); SanjaySharma,Sr VP& Head-Manufacturing Science and Technology,Zydus Group and VijayCharlu,President,Corona Remedies

The inaugural session at Ahmedabad Pharma Summit 2024 was a panel discussion titled "Why Ahmedabad is a Go-To Destination for Pharma Manufacturing." Industry experts convened to understand the factors driving Ahmedabad's rise as a premier hub for pharma manufacturing.

Led by SG Belapure, Senior Technical Advisor at IPA, the discussion brought together esteemed panelists who provided valuable insights on Ahmedabad's pivotal role in India Pharma Inc’s growth story. Belapure was joined by Dr Viranchi Shah, National President, IDMA; Vijay Charlu, President, Corona Remedies; Rajiv Gandhi, CEO & MD, Hester Biosciences; and Sanjay Sharma, Senior VP & Head-MS&T, Zydus Group for this discussion.

The discussion commenced with the panelists highlighting the key factors that have propelled Ahmedabad to be a key hub for the pharma sector. They emphasised the city's entrepreneurial mindset, conducive business climate,

KEYTAKEAWAYS

1.Ahmedabad's entrepreneurial mindset,conducive business climate,and abundant resources have made it a leading pharma hub

2.Gujarat's significant contribution to India's pharmaceutical industry,producing one-third of the country's drugs and exporting 28 per cent of its pharmaceuticals

3.Reputed academic institutions in Gujarat have contributed to the creation of a strong and skilled workforce in Ahmedabad

4.Ahmedabad's expertise,experience,India-first approach,great connectivity,and facilitative policies have fueled its growth as a major pharma hub

5.Supportive regulators,facilitating policies,and a cohesive environment have driven Ahmedabad Pharma Inc's growth story

and abundant resources as catalysts for its success in this industry.

Then, they shed light on Gujarat's significant contribution to India's pharma industry, citing statistics that underscored the state's pivotal role. It was noted that Gujarat produces one-

third of the drugs manufactured in India and exports approximately 28 per cent of the drugs produced, solidifying its status as the pharmacy of India.

The discussion also focused on the role of reputed academic institutions in Gujarat in nurturing a skilled workforce,

which has been instrumental in Ahmedabad's success as a pharma hub. Key collaborative efforts between academia and industry in fostering talent development and innovation were also highlighted.

The panelists stressed on Ahmedabad's expertise and experience in pharma manufacturing, coupled with an India-first approach and excellent connectivity and transport facilities. The city's ability to attract top talent and investment was also cited as a reason for its growth into a major pharma hub.

Over the course of the discussion, the panelists also stressed the importance of facilitating policies and supportive regulators in Ahmedabad's pharma growth story. The cohesive environment created by industry stakeholders, regulators, and policymakers, has fostered a conducive ecosystem for pharma manufacturing, according to the experts on the panel.

The panel discussion gave a deeper understanding of the city's strengths driving its success in the pharma sector.

Polymeric solutions for pharma industry

Prabhat Balyan, Business Development Manager, Ami Polymer gave an informative presentation showcasing his organisation’s latest innovations and developments.

He said that Ami Polymer, established in 1998, has continually tried to improve and enhance its offerings of polymeric products. He also informed the audience about the company’s new facility in Kala, Dadra Nagar Haveli which will boost its manufacturing capabilities.

He also showcased a diverse range of products from the company tailored

such as tubings made of silicone, TPE, and fluoropolymer to single-use plastic components and bags etc.

Balyan also introduced the Ami Polymer's sterile sampling system. He highlighted that this system reduces the risk of contamination, thereby ensuring the integrity of pharma samples.

He also gave a sneak peek into the company’s ongoing research and development efforts and assured the audience that Ami Polymer’s products are made in adherence to international standards and tests, ensuring

Creating and training a future-readyworkforce

Naresh Gaur, Sr VP – Manufacturing Operations, Amneal Pharma gave a detailed presentation on strategies for reskilling and upskilling the pharma workforce in the face of disruptive technological advancements.

He delved into the critical need for workers to adapt swiftly to emerging technologies such as such as AI, IoT, data sciences, cybersecurity, etc, and underscored the importance of fostering a culture of continual learning and development.

He spoke on building a futureready workforce by establishing specialised centers such as Skill Development Centers and Centers of Excellence. He also advised the industry to identify training needs, select trainees, and motivate them by

aligning training initiatives with performance appraisals.

He also shed light on the top 10 skills identified by the World Economic Forum as crucial for reskilling and upskilling. Key skills included analytical thinking, active learning, leadership, and proficiency in emerging technologies, underscoring the importance of adaptability and agility in today's workforce.

He advocated for a comprehensive framework to guide organisations in workforce planning, skill identification, modernising learning strategies, and integrated learning to develop future-ready workforces.

The overarching message was the importance of cultivating a culture of continuous learning to thrive in the rapidly evolving landscape.

Technologyleadership and brand repositioning

Sri Harsha V, AVP – BD and Sales, Sigachi Industries explored technology leadership and brand repositioning in his session at Ahmedabad Pharma Summit 2024. The session provided valuable insights into the evolving landscape of pharma and the role of innovative dosage forms, especially in addressing the needs of elderly patients.

Sri Harsha stressed the importance of technology leadership in the pharma industry. Emphasising the need to identify target audiences and highlight unique brand propositions, he also explored strategies to curate compelling brand positioning that resonate with consumers.

A significant portion of the session was dedicated to understanding the unique challenges faced by geriatric patients in medication adherence and acceptance. Topics such as polypharmacy, swallowability, and palatability were discussed, shedding light on the importance of developing age-appropriate drug delivery solutions.

Attendees learned about the benefits of mini-tabs and multi-particulate drug delivery systems in reducing pill burden and improving therapeutic

Sri

Harsha V,AVP– BD and Sales,Sigachi Industries

Technology leadership involves age appropriate drug delivery. Sigachi can be a good partner for pharma companies seeking business growth through technological innovation

outcomes for elderly patients.

He also showcased Sigachi's range of high-functionality excipients and pre-formulated offerings tailored to meet the unique formulation requirements of mini-tabs. He reiterated that Sigachi can be an ideal partner for formulation development and excipient solutions.

Naresh Gaur,Sr VP- Manufacturing Operations,Amneal Pharma

Opportunities and challenges for quality

Dr Girisha Patel, Head - Corporate Quality, Corona Remedies conducted an insightful session at Ahmedabad Pharma Summit 2024, shedding light on the challenges and opportunities in quality management. The session provided invaluable takeaways into fostering a culture of quality excellence within organisations.

Dr Patel commenced the session by emphasising the pivotal role of organisational culture in shaping quality standards. She highlighted that quality starts from the very fabric of an organisation's culture, encompassing shared beliefs, employee treatment, and behaviour.

Dr Patel also delved into the various challenges faced by organisations in maintaining quality standards including excessive documentation, human resource development, management commitments, lack of process, outdated technology, changing requirements, and misunderstanding customer needs. She un-

Dr Girisha Patel,Head - Corporate Quality,Corona Remedies

derscored the importance of addressing these challenges to uphold

high-quality standards in pharma operations.

Dr Patel pinpointed factors such as the lack of logical understanding during document creation, undefined selection and development criteria, time-based directives, poor subject knowledge, resistance to change, slow response for adaptation, and reluctance to welcome new ideas as factors causing challenges to quality.

Moreover, providing practical strategies for overcoming these challenges and seizing opportunities on a day-to-day basis, she emphasised the importance of accountability, compliance, ownership, management focus, systematic approaches, quality matrices, and proactive, risk-based strategies.

The session comprised several insights for organisations to rethink their approach to quality management, and pave the way for enhanced efficiency and compliance.

Transforming pharmaceutical excellence: Introducing L4 solution for next-generation traceabilityand efficiency

Hiren Rathod, Regional HeadSales (West & Madhya Pradesh), Optel Group gave a sessionat the Ahmedabad Pharma Summit 2024 about Optel's innovation the Verify L4 Solution, and how it can usher traceability and efficiency in pharma operations. The session titled, 'Transforming pharmaceutical excellence: Introducing L4 solution for next-generation traceability and efficiency', focused on Optel's next gen pharma traceability solutions.

He started his session by informing the audience about Optel's expertise in traceability and vision systems. Then, he gave an in-depth overview of the Verify L4 Solution, highlighting its

differentiators, key features, and modules. He said that with a focus on transparency, efficiency, and compliance, Verify L4 offers a comprehensive suite of tools designed to streamline traceability processes and drive operational excellence.

He went on to inform that the Verify L4 Solution sets itself apart with its transparent pricing model, robust reporting capabilities and validation processes, which reduces efforts and ensures compliance with regulatory requirements such as DSCSA.

He concluded his session by assuring the audience that Optel's solutions can help the pharma companies to enhance their operations and mitigate risks.

Hiren Rathod,Regional Head - Sales (West & Madhya Pradesh),Optel Group

Building next-gen pharma facilities

Sanjay Singh, VP-Operations, Cadila Pharmaceuticals delivered an interesting presentation on "Building next-gen pharma facilities" during Ahmedabad Pharma Summit 2024. Singh highlighted the importance of leveraging digitalisation, automation, robotics, and nextgeneration analytics to create futureready pharma facilities.

Singh provided an overview of the challenges faced by traditional pharma facilities, including late material deliveries, paper-based processes prone to errors, demand fluctuations, production non-transparency, and rising cost pressures. He emphasised the need for next-gen facilities to install digital and flexible production operations, implement augmented reality for efficient line set-up, integrate ERP systems with shop floors for production transparency, and adopt real-time integrated production planning and scheduling.

To overcome quality operation challenges, Singh recommended digital quality controls, optimising processes, real-time feedback, visual quality inspections, advanced data analytics, and full automation of testing.

Singh opined that next-gen pharma

facilities have the potential to drastically increase agility, efficiency, flexibility, and quality in industrial production processes. He highlighted the significant benefits that pharma supply chains, production processes, dis-

tribution, and inventory frameworks could derive from the adoption of nextgen technologies and strategies.

Singh underscored the importance of embracing digitalisation, automation, and advanced analytics to

Next generation pharma facilities should be created by leveraging digitalisation, automation, robotics and next generation analyticssupported by the right set of strategies, processes,people, culture and partners

enhance operational efficiency, quality, and flexibility in pharma manufacturing.

Smart manufacturing technologies for pharma industry

Ashwani Kumar Verma, Senior General Manager - Operations at Intas Pharmaceuticals spoke on "Revolutionising Pharma Production: Smart Manufacturing Strategies" at Ahmedabad Pharma Summit 2024. It covered various aspects of smart manufacturing in the pharmaceutical industry.

Highlighting the multifaceted challenges faced during production, including stringent regulations, quality control, and supply chain management, he pointed out that inefficiencies in production processes often lead to increased costs and time-to-market delays and emphasised the need for smart manufacturing solutions.

He also spoke on several key technologies driving smart manufacturing in the pharma industry, such as advanced robotics, additive manufacturing/3D printing, IoT, AI, cloud computing, and

cybersecurity.

He gave an overview of the evolution of pharma manufacturing processes and accentuated the role of digitalisation in transforming pharma manufacturing. He also showcased how smart manufacturing technologies like SAP S4 Hanna, LIMS, MES, SCADA, IoT sensors, robotics, track and trace, and digital twin/simulation/AR/VR etc enhance process efficiency, improve product quality, boost production capabilities, reduce time to market, enable cost savings, and ensure compliance with regulatory standards.

Thus, the session provided valuable insights into the potential of smart manufacturing and reiterated how leveraging advanced technologies and adopting a holistic approach to digitalisation can help pharma companies to enhance efficiency, quality, and compliance while addressing business and digital challenges.

SanjaySingh,VP-Operations,Cadila Pharmaceuticals

Ashwini Verma,Sr GM-Operations,Intas Pharmaceuticals

Emergent technologies and systems in steam sterilisation and glassware washing

The session on "Emergent Technologies and Systems in Steam Sterilisation and Glassware Washing," was delivered by Sagar Shah, Director, Equitron Medica. He provided insights into advancements in laboratory sterilisation and glassware washing technologies.

He shared valuable insights into key considerations for steam sterilisers, such as the importance of orbital welding, how swept-piping design minimises dead-leg etc. The session also highlighted considerations while choosin how to select horizontal and vertical autoclaves, with a focus on optimising loading capacity and overcoming common servicing issues. He

Sagar Shah,Director,Equitron Medica

also addressed the need for routine maintenance and validation procedures to ensure integrity and efficacy of autoclaves.

On glassware washers, Shah spoke on the importance of full-sized glass doors for monitoring the wash process and avoiding sample contamination. Overall, the session provided valuable insights into the latest advancements and best practices in steam sterilisation and glassware washing technologies. Attendees got insights on key considerations such as certification, efficiency, and water conservation, along with practical strategies for optimising autoclave and glassware washer performance in laboratories.

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Panel Discussion: Decoding the path to progress

Prashant Sharma,CTO,Zydus (Moderator),Pradipta Kumar Swain,COO,Innoxel,Mahesh Bhalgat,Group CEO,Veeda,Parag Swadia,CEO,Otsuka Pharma,Sudhir Vaid,CMD,Concord Biotech

The final panel discussion at Ahmedabad Pharma Summit 2024, organised by Express Pharma, was a riveting one. Titled, "Decoding the Path to Progress," it was moderated by Prashant Sharma, Chief Technology Officer at Zydus. He was joined by a stellar lineup of industry leaders who sought to unravel the strategies driving the pharma industry forward. They were Pradipta Kumar Swain, COO, Innoxel; Dr Mahesh Bhalgat, Group CEO, Veeda; Parag Swadia, CEO, Otsuka Pharma and Sudhir Vaid, CMD, Concord Biotech.

The discussion offered a lot of food for thought and touched upon several key issues and aspects that are crucial for the industry’s sustained progress. The panelists emphasised the importance of aligning vision and values across all organisational levels for sustained success. They highlighted the significance of this alignment in fostering a cohesive organisational culture.

KEYTAKEAWAYS

1.Vision and values must be aligned across all levels for organisational success

2.Cultivating leaders at all levels is essential for long-term sustainability

3.Leaders playa crucial role in building a culture of qualityand accountability

4.The right talent is vital for creating patient-centric and forward-looking organisations

5.Continuous upgrading and upskilling are imperative for thriving in a rapidly evolving industrylandscape

The discussion also debunked the notion of "superhero leaders." Panelists pointed out that while strong leadership is essential, the cultivation of leaders at all levels is the key for long-term success. They emphasised that “leaders make leaders," and underscored the importance of nurturing talent and empowering individ-

uals to take ownership and initiative.

The discussion also accentuated the importance of walking the talk to build a culture of quality and accountability within organisations. The leaders on the panel agreed that it is important to lead by example and create an environment where quality is ingrained in every aspect

of operations.

The panelists also drew attention to the critical role of talent acquisition and development in driving organisational progress. The need for the right talent, both at the corporate and site levels, to create patient-centric and forward-looking organisations was underscored. They importance of investing in talent and fostering a culture of continuous learning and development was particularly highlighted.

Panelists unanimously agreed that in an era of transformation, organizations must prioritize continuous learning and adaptation to stay ahead of the curve.

The discussion concluded with valuable insights and actionable strategies to navigate the path to success in an increasingly complex and dynamic environment. As the pharma industry continues to evolve, discussions like these serve as catalysts for innovation, collaboration, and growth.

RESEARCH

AI: The elephant in your lab!!

Dr Ashok Kumar,President-CRD,IPCALaboratories explores the impact of AI in scientific research and drug development,from predicting protein structures to self-driving chemistry labs. He points out that AI is revolutionising how we approach complex tasks,and in future,AI-driven innovations may reshape our understanding of science and enhance productivity

Technologies are evolving quickly, and some of them could significantly alter the kinds of goods and services we are accustomed to as they are so disruptive. Disruptive technologies, whatever their nature, have greatly improved our work and lifestyle. Computers, the Internet, Google search engines, and smartphones, while partially to blame for the demise of many indispensables in the recent past, like the gramophone, telegraph, and typewriter, have had a profound impact on both our professional and personal lives.

The most significant shift that is currently occurring is the result of artificial intelligence (AI) and machine learning (ML), which have made thinking machines more dependable and efficient than people at handling tasks like gathering and aligning data, analysing it, and making better decisions. Like humans, it gains efficiency over time by constantly learning from experience, but, on the contrary, without incurring errors (positive), in whatever activity it undertakes.

Two of the most significant turning points in the history of artificial intelligence were Deep Blue's 1997 victory over chess champion Garry Kasparov and Deep Mind's 2016 victory over Go champion Lee Sedol, both of whom were thought to be beyond the capabilities of the most advanced computer systems. The key characteristic of the Alpha Go algorithm is that, instead of only reacting to the information that is provided, it learns the game's rules, uses tactics that have never been considered by humans, and even finds new rules as it goes.

Another example of a coming technology that will un-

AI has already made deep inroads in areas of scientific research.It will revolutionise scientific research by bringing new insights from experiments because of its ability to learn more than a billion times faster, gobble up unlimited data, retrieve information at the speed of light,and draw quick conclusions from massive and even disorganised datasheets that are incomprehensible to the human mind

doubtedly alter the direction of the automotive industry and those connected to it is the development of AI-powered self-driving cars.

Nonetheless, Chat GPT, which debuted at the end of

2022, might be regarded as a true disruption of the present. In just five days following its release, over a million people looked at it for different reasons. It genuinely deserves the acclaim it has received, as it

not only provides concise and straightforward answers to the questions but also explains the ideas in plain language. Not only does it create original ideas, but it also offers advice on how to plan events and businesses, composes articles, essays, and poems on the subjects assigned, solves challenging arithmetic problems, and even helps select appropriate gifts for specific occasions.

Launched on March 14, 2023, ChatGPT-4 is its next avatar and is 40 per cent more effective than its predecessor at providing factual responses. It is trained in around 26 languages, has a larger general knowledge base consisting of approximately 100 trillion parameters compared to 175 billion, and can solve complex problems. It is not just eighty percent more intelligent at spotting unnecessary queries, and it can also take image inputs in addition to text. In contrast, GPT-3.5 is limited to processing text inputs. Because ChatGPT-4 is interactive, it answers follow-up inquiries, acknowledges errors, refutes false premises, and grows from its mistakes.

When compared to the caliber of human professionals, GPT-4 has scored in the 90th percentile on US bar exams and shown above-average undergraduate ability in medical assessment exams and coding, which calls for strong math and science knowledge.

It is easy to see from these advancements that AI/ML will continue to advance in capabilities, and depending on how we interpret these developments, their future iterations will continue to astound or surprise us.

AI and scientific research

Traditionally, people have

thought that creative and innovative vocations, including the fine arts, science, and complicated decision-making requiring critical thinking, are exclusively human domains and will never be impacted by AI. But it doesn't seem like this theory is correct, as exemplified by a few recent developments in chemistry and related fields.

New drug discovery: Finding new targets is essential to developing new drugs, but doing so demands a difficult-to-get structural understanding of proteins and how they behave. In this regard, the DeepMind algorithm AlphaFold has significantly enhanced the ability to predict the three-dimensional (3D) structures of proteins from their amino acid sequences. It disclosed the projected structures of over 200 million proteins that are currently known to science or humanity in July 2022. It's crucial to remember that, thanks to this new technology, determining a protein's 3D structure may now be completed in a matter of hours as opposed to years.

For example, when protein structure is unknown, AlphaFold can be used in conjunction with two other AI tools, PandOmics and Chemistry 42, to enable an end-toend procedure for the new discovery. Target discovery engine PandOmics sheds light on the association between a target and a disease, while Chemistry 42 proposes binding sites for putative drug candidates by analyzing AlphaFold's predicted protein structure (ChemWorld '40, March '23). Because AlphaFold2 can anticipate multiple protein configurations, it is not only helpful for researching protein dynamics but also has the potential to revolu-

tionise drug development by identifying new targets. New drug development: The field of new drug development is expanding its use of AI and big data in a synergistic way. This includes lead optimisation and the prediction of the pharmacokinetics (ADMET) of possible drug candidates, in addition to early drug discovery that focuses on creating new targets or hits. Clinical trial patient subgroup selection and trial prediction are now commonly done by AI, which helps significantly cut down on costs, time, and, of course, late-stage failures. It is crucial to understand that bringing a new medication to market can cost up to several billion US dollars and take 12 to 15 years. According to the CPhI Annual Report of 2023, which is based on data from 250 international pharmaceutical companies, more than half of all approved medications would use artificial intelligence (AI) in their development or production within ten years.

Because AI can process and analyse large, complex data sets to find patterns that are invisible to the human eye but essential for accurately determining the underlying cause of an illness and, of course, choosing the best course of treatment, it has already proven to be a game changer in the healthcare industry.

Enzyme function prediction: CLEAN, a novel deep learning system, makes predictions about the function of enzymes by analysing their amino acid sequences. This online tool, which is free to use, can assist in swiftly characterising and identifying the appropriate enzyme for the intended production of a substance or chemical.

(www.science.org/doi/10.1126/science.adf2465) .

Enzyme engineering: An enzyme created by an AI/ML system that breaks down plastic may depolymerise a whole plastic tray in less than 48 hours. It accomplishes this for fifty-one (51) distinct PET products more quickly and even at lower temperatures

than the next best thing that was created by humans (Nature 604, 662, 2022).

De Novo enzyme design: The development of unique proteins with novel behaviors, functions, or goals has been made possible by directed evolution. Ho wever, the lack of knowledge of the physicochemical forces at work necessary to give a protein its threedimensional shape continued to hinder the design of a protein from scratch. With the aid of recently developed AI technologies, this now seems to be feasible as well.

For instance, researchers can construct novel protocols utilising various algorithms, such as the open-source AI platforms ColabFold, and ColabDesign to produce structures, design sequences, and fold to validate proposed sequences that could create the designed proteins. It is crucial to understand that researchers can now employ these methods without being constrained by their understanding of the physics and chemistry of these molecules.

A new generative AI model called CHROMA has recently been shown to create artificially intelligent proteins with programmable features that have the potential to be curative (C+EN, Nov. 2023, 24).

Synthetic route design: Synthia, Chemetica's newest incarnation, recommends synthetic routes for complicated molecules using a retro-synthetic methodology. It is based on 100,000 hand-coded rules and a database. Additionally, novel strategies that are almost unheard of in the literature are suggested by this Merck KGA tool.

ROBOT RXN, the algorithm developed by IBM, is comparable to Synthia, makes > 4 million reaction predictions, and is already used by > 30000 chemists worldwide.

Reaction condition predictor: The AI empowered robot that learns from the outcomes of the reaction not only predicts the best conditions but also carries out the experiments using the predicted conditions to give double the human optimised yield in

Suzuki- Miyamura coupling reactions.

Furthermore, Chemists can improve reaction quality and prevent certain side reactions by using the cheat sheet that was developed from meta-analyses of all the literature on Buchwald-Hartwig (>62000) reactions. In order to promote the intended changes more successfully, the algorithm also anticipates the use of suitable reagents and conditions.

Another machine learning system called Labmate makes recommendations for the temperature, solvent concentration, and anticipated duration of a given reaction in order to help optimise the reaction conditions and produce the highest yields. Additionally, it suggests doing experiments to try to improve upon the current state of affairs (DOI: 10.1016/j.xerp.2020.100274).

Enantioselectivity prediction: Trained to determine the activation energy for the competing R and S pathways, which can then be translated to enantiomeric excess (ee), is quite remarkable in predicting the enantioselectivity of an asymmetric transformation (DOI:10.1038/s 41560-02100813-w).

Atom tracking: Without human assistance, an ML algorithm called RXN Mapper can track atoms in the product from reactants with >99% accuracy (Nature Communications (DOI: 10.1038/41467-01909990-2).

Catalyst discovery: In its first project, the robot chemist in Andy Cooper's lab at the University of Liverpool carried out 688 experiments in eight days by modifying ten variables, ultimately finding a photo-catalyst mixture that was six times more active than

the original formulations (Chem World P23, Feb. 2023). Stereospecific C-C bond formation: The core component of the naturally occurring neurotoxic substance Kalkitoxin, which is produced by a cyanobacterium, is made using a fully automated robotic platform that enables carbon chains to be grown one atom at a time with control over chain length and stereochemistry.

Self-driving chemistry labs

An end-to-end AI research assistant called Coscientist, which decides reaction conditions and also writes codes for automated systems based on single English Prompt has recently demonstrated Suzuki and Sonogashira coupling reactions without any human intervention. Interestingly, it designed experiments suitable enough to be performed within the hardware that was available, executed them, and analyzed the results, as expected from a chemist to give the output (Nature 2023, 62Pg, 570; Chem.World P41, Feb. 2024).

Another advanced LLM version of Chatbots, namely ChemCrow, has also demonstrated capabilities similar to or better than those of Coscientist. When asked to make an insect repellant, ChemCrow first carried out a literature search to find one, translated its chemical name into SMILES, designed the synthesis, and operated the robotic laboratory system at IBM to produce a physical sample of DEET, a known insect repellent, without any human assistance (DOI:org/10.48550 /avXiv.230 4.05376).

Yet another example of a self-driving lab is AlphaFlow, which produces derived Quantum dots by managing more than 40 variables of the reaction condition, allowing it

to discover > 1012 potential sequences in a month, and that too using a novel recipe (C+EN P4, April 17/24, 2023). Like the previously mentioned cases, it completed the task without the need for human assistance.

The final word

There are enough reasons in the aforementioned description to conclude that AI has already made deep inroads in areas of scientific research. It is not difficult to imagine that artificial intelligence (AI) will rev olutionise scientific research by bringing new insights from experiments because of its ability to learn more than a billion times faster, gobble up unlimited data, retrieve information at the speed of light, and draw quick conclusions from massive and even disorganised datasheets that are incomprehensible to the human mind. I-agent systems, which are quickly approaching, will soon provide the current LLMs with abilities like self-thinking, brainstorming, and refining data while handling or researching complex tasks!

This is just the beginning. Imagine what AI will be able to do when a highly developed generative AI architecture backed by a quantum computer endowed with all the principles, rules, and knowledge of the chemical or biological sciences becomes accessible!

Be assured, this will occur sooner than anticipated!

One might think that AI will never surpass human intelligence or be able to completely replace people (hope it proves true in the future), one thing is certain: those who understand when and how to use AI to get the most out of life and work will undoubtedly replace those who haven't learned to make friends with this behemoth!!

Suzuki- Miyamura Reaction

Buchwald-Hartwig Coupling Kalkitoxin

STRATEGY

Global healthcare partners and Indian pharma companies: Making medicines affordable

Dr Anil Gulati,Chairperson and CEO,Pharmazz highlights that our country plays a pivotal role in delivering quality-certified medications at significantly lower costs,with its dominance in generic medicine production,resilience amidst the COVID-19 pandemic,leadership in vaccine manufacturing,and collaborative efforts in research and development

In the expansive landscape of global healthcare, India has emerged as a pivotal player, shaping the accessibility and affordability of essential medicines worldwide. As the world’s leading supplier of generic drugs, India’s pharmaceutical industry has become a ray of hope for millions as it ensures quality-assured and cost-effective treatments reach those who need them the most. With its dominance in generic medicine production, resilience amidst the COVID-19 pandemic, leadership in vaccine manufacturing, and collaborative efforts in research and development, our country plays a pivotal role in delivering quality-certified medications at significantly lower costs.

Dominance in generic medicine production

India’s capability in the pharmaceutical sector is evident in its staggering production figures. The country accounts for 20 per cent of the world’s generic drugs and 60 per cent of the global vaccine supply. It also contributes to 40 per cent of medications in the US and 33 per cent in the EU. This dominance is built upon a robust infrastructure, stringent quality control measures, and a firm commitment to delivering high-quality generic alternatives at significantly lower costs than their branded counterparts.

Resilience in challenging times

The COVID-19 pandemic presented unprecedented challenges, yet it also catalysed the growth of the Indian pharmaceutical industry. Driven by

the urgent need for essential medicines, vaccines, and medical supplies, India’s swift response in ramping up production underscored its reliability and resilience in times of crisis. The industry’s ability to rapidly adapt and meet global demands ensures India’s position as a trusted partner in global healthcare.

Vaccine manufacturing leadership

India’s leadership in vaccine manufacturing is unparalleled, with the country producing 60% of the world’s vaccines. Indian pharmaceutical companies play a crucial role in fulfilling global demand for critical vaccines, including those en-

dorsed by the World Health Organization (WHO) for diseases (like Tetanus, Pertussis, Diphtheria, and Bacillus Calmette-Guerin), highlighting India’s indispensable contribution to global immunization efforts.

Transforming access to treatment

The availability of affordable generic alternatives from India has catalysed significant improvements in access to treatment, particularly in combating diseases like AIDS. Between 2003 and 2009, the number of AIDS patients receiving treatment increased 18-fold, thanks to the accessibility of affordable medica-

tions. This impact extends beyond borders, with North America emerging as a key market and accounting for 34 per cent of India’s pharma exports, closely followed by Africa at 19 per cent. The impact of India’s pharma exports will likely improve access to cost-effective treatment for many other diseases worldwide.

Collaborative efforts for innovation

Global healthcare partners often collaborate with Indian pharma companies in joint research and development initiatives. It enables the sharing of knowledge, resources, and expertise and leads to the development of more cost-effective medicines. Such partnerships are particularly valuable in addressing the healthcare needs of low- and middle-income countries.

Facilitating technology transfer

Global healthcare partners frequently leverage technology transfer programs with Indian pharmaceutical companies. This process involves transferring manufacturing know-how and processes, enabling the production of affordable generic versions of patented drugs once their patents expire. It facilitates the availability of affordable alternatives to expensive medications, ultimately benefiting patients worldwide.

Government support and industrystrategies

The Indian government’s initiatives, such as the Production Linked Incentive (PLI)

scheme, aim to bolster the domestic active pharmaceutical ingredients (API) industry. By strengthening indigenous manufacturing capabilities, these initiatives reduce dependence on imports and ensure a stable supply of essential medicines that align with long-term healthcare goals.

Strategies for market expansion

Amidst evolving global dynamics, Indian pharma companies are exploring new export markets and diversifying their supply chains. The COVID-19 pandemic has prompted a re-evaluation of global drug supply chain models, emphasising resilience and adaptability. India’s reputation for affordable, quality manufacturing positions it favorably to capitalise on emerging opportunities and consolidate its global leadership in the pharmaceutical sector.

Conclusion

The collaborative efforts of global healthcare partners and Indian pharma companies have been instrumental in making essential medicines more accessible and affordable worldwide. Through research, development, manufacturing, and advocacy, they collectively address global health challenges and improve the quality of life for millions. As the world caters to the evolving healthcare dynamics, this essential partnership will continue to play a pivotal role in ensuring equitable access to lifesaving treatments and driving progress toward a healthier, more inclusive global community.

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PHARMA PULSE

Unity600 blister packaging line from Romaco Noack

For more sustainability and performance

The Unity600 blister packaging line from Romaco Noack impresses with more sustainability coupled with the highest possible performance and process reliability. Furthermore, for the first time, the monobloc’s inn ovative transfer unit enables blisters to be traced back to the primary packaging unit.

Romaco Noack has expanded its state-of-the-art Unity family with the Unity 600 blister packaging line. The technology leads the way in terms of sustainability, process reliability and performance. The heart of this monobloc is the innovative transfer unit, which is not only designed for much higher cycle numbers, but also provides more format flexibility as well as better traceability and energy efficiency. All in all, the double-lane high speed line – comprised a blister machine with rotary sealing and a continuous motion cartoner – achieves a maximum output of 600 blisters and 350 cartons per minute. With a maximum foil width of 304 mm, blister packs up to 145 mm long and 90 mm wide can be safely processed.

And for all applications demanding even higher performance, Romaco offers a three-lane version of the Unity600 with an output of up to 750 blisters per minute.

More energyefficiency byeliminating vacuum pumps

With the Unity600, blisters are transferred to the cartoner via an indexing wheel with a downstream stack transfer unit. First, the diecut blisters are removed from the die-cutter by vacuum and then placed on the transfer belt to the cartoner by a carousel-shaped shuttle. The vacuum is generated in a Venturi process, eliminating the need for a conventional vac-

uum pump. Apart from reducing noise emissions, this has the advantage that significantly less heat radiation is emitted in the cleanroom –which would have to be cooled down in an energy-intensive operation. What’s more, the suction cups of the indexing wheel are only ever active while blisters are being transferred. This means that no air is drawn in erroneously and power consumption is min-

imised.

Better traceabilityin the primarypackaging process

The Unity600’s stack transfer unit stacks the blisters from below and guides them safely from all sides, ensuring ultra-stable processes that are gentle on the product. The blister stacks are subsequently positioned one behind the other in the cartoner’s

bucket chain by so-called stack carriers. Only complete stacks are transferred to the cartoner. For the first time, any compensation of gaps in the process is mapped in the software, so that good blisters no longer have to be held back. As a result, a manual blister top-up magazine can be dispensed. This highly automated transfer solution from Romaco Noack additionally allows seamless tracking and tracing of blister packs from the product feeding unit onward.

Features for more sustainability

Romaco Noack’s Unity600 was developed according to the principle “avoidance is better than reduction is better than compensation”, the aim being to dramatically reduce the blister packaging line’s carbon footprint both during its manufacture and later in operation. That is why the line ships with an energy monitor that measures not only power and air consumption, but also the machine’s carbon dioxide emissions during production. Its smart standby functions enable a reduction in base load without any negative impact on OEE (overall equipment effectiveness). Components made from carbon-reduced ASI aluminum and a recycled acrylic glass housing give the line an even better environmental balance. The insulated heating plates of the blister forming station moreover restrict the amount of waste heat in the air-conditioned primary packaging room. And the cartoner abides by the same principle: Romaco relies on the more sustainable Venturi process to produce the vacuum that is essential for carton and leaflet pick up. Last but not least, the blister line features motors with energy recovery.

The Unity600 can be sup-

plied in a carbon-neutral version on request. Romaco’s offsetting initiatives are undertaken together with Forliance – one of the “Alliance for Development and Climate” foundation’s offsetting partners –on behalf of the German Federal Ministry for Economic Cooperation and Development.

Wide range of applications

The Unity600 blister packaging line from Romaco Noack meets all the requirements of the pharmaceutical and nutraceuticals industry when it comes to flexibility, quality and performance. The technology is utilised for the primary packaging of solid products such as tablets, capsules and oblongs, and is also suitable for manufacturing sustainable packaging like paper blisters. This GMP compliant line convinces with excellent OEE values – due to short changeover times and very good line clearance.

On show at Achema in Frankfurt/Main (Germany) from June 10 to 14, 2024 (Messe Frankfurt, Hall 3.0, Booth B49).

For more information on Romaco, visit: www.romaco.com

Company contact Susanne Silva

Market Communications

Romaco Group Am Heegwald 11 76227 Karlsruhe

Germany

T: +49 (0)721 4804 0 E: susanne.silva@romaco.com

Press contact Micha L. Harris

Senior PR Consultant Carta GmbH

Iggelheimer Str. 26 67346 Speyer

Germany

T: +49 (0) 6232 100 111 20

E: harris@carta.eu

Unity600 blister packaging line from Romaco Noack

Blister transfer with the Romaco NoackUnity600’s indexing wheel

Stacktransfer unit of the Romaco NoackUnity600

PHARMA PULSE

Waters launches newGTxResolve Premier SEC columns

New line of GTxResolve Premier SEC Columns provide higher sensitivity,resolution,and throughput to accelerate the development of cell and gene-based therapeutics.

Waters Corporation has introduced new GTxResolve Premier Size Exclusion Chromatography (SEC) 1000Å 3micron (3 μm) Columns. Waters has implemented a unique combination of novel packing materials and MaxPeak Premier High-Performance Surface (HPS) technology into the columns to help scientists accelerate the development of gene-based therapeutics, including cell & gene, mRNA and LNPs.

The pipeline of nucleic acid therapeutics continues to grow at a double-digit pace as developers strive to submit new investigational drug filings and complete their first in-human trials. The new Waters GTxResolve Premier SEC Columns supports the growing demand for mRNA, lipid nanoparticle, and viral vector-based therapies with columns that are more robust and provide higher efficiency. These SEC columns help to standardise measurements needed to fulfill biological license applications, achieve accelerated approvals, and establish effective release testing strategies," said Erin Chambers, VP, Consumables and Lab Automation, Waters Corporation.

SEC has emerged as an important platform analytical technique, but existing technologies require extensive column conditioning, consume large amounts of sample, and require lengthy run times to resolve impurities, making them an imperfect solution.

Waters GTxResolve Premier SEC 1000Å 3 μm Columns address those challenges by providing higher sensitivity, resolution, and throughput by combining novel particle technology with low adsorption MaxPeak Premier HPS Technology. They make it possible for scientists to assess drug safety and efficacy more quickly and expedite the development of gene-based therapeutics and vaccines that are both more efficacious and accessible to patients globally.

"RNA lipid nanoparticles are analytically complex ther-

apeutics. Traditional batch analysis techniques only discern information of the drug product as a whole and fail to detect the subtle difference in particle size populations and corresponding compositional variations therein. SEC analyses afforded by these new column technologies are promising because they have shown separations of LNP populations that can be coupled with online or offline detection. These insights could aid the development of more potent, more stable LNP therapeutics," said Adam Crowe, Analytical Development Manager, Precision Nanosystems.

GTxResolve Premier SEC Columns are engineered to reduce problematic non-specific binding, minimise mobile phase method development challenges, and provide higher throughput separation effi-

Reduces problematic nonspecific binding,minimises mobile phase method development challenges,and provides higher throughput separation efficiency.Increases resolution up to 50 per cent for components present within mRNA,lipid nanoparticles (LNP),and viral vectors for more confident measurement of critical quality attributes tied to safety,stability,and potency

ciency. They offer up to 50 per cent increases in resolution for components present within mRNA, LNPs, and viral vector samples. They offer low out-ofthe-box secondary interactions, enabling robust multi-attribute platform methods and more than 2x improvements in sample consumption, run times, and sensitivity versus existing 5 and 10 μm HPLC columns.

Waters GTxResolve Premier SEC 1000Å 3 μm Columns are now available globally, alongside Waters previously released GTxResolve Premier BEH SEC 450Å 2.5 μm Columns. These column technologies are quality control batch-tested with an industry-first use of both protein and nucleic acid test mixtures to ensure new levels of separation reproducibility.

Automation Studio CoPilot: Your AI companion for B&R software

With clearly structured,well commented code,CoPilot makes collaboration more efficient, helping teams spend less time troubleshooting and more time innovating

In today’s industrial landscape, the software is getting more and more powerful to help machine developers. The newly released Automation studio 6 introduces CoPilot which helps with creation of machine software in languages like Structure Text, C and C++. At the click of a button engineers can leverage the power of generative AI to generate and optimize code. The system is designed to integrate effortlessly with B&R's existing libraries and conventions, so there's no learning curve. The result will have a significant reduction in manual coding that frees up engineers to focus on more creative problem-solving and rapid prototyping.

ABB Group) | Pune

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Time-to-market is an essential metric for any business, especially in the rapidly evolving machine automation industry. CoPilot empowers developers to manage increasingly complex systems efficiently. It simplifies workflows and reduces time to market for new machines, providing a substantial competitive edge to help machine builders lead in competitive markets. Code quality is another critical focus area for machine builders, and that’s where CoPilot's automated code commenting, and optimization features come into play. The software intuitively annotates code, improving both readability and longterm maintainability. With clearly structured, well commented code, CoPilot makes collaboration more efficient, helping teams spend less time troubleshooting and more time innovating.

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CoPilot empowers developers to manage increasingly complex systems efficiently.It simplifies workflows and reduces time to market for new machines, providing a substantial competitive edge to help machine builders lead in competitive markets

PROSOLV® SMCC byJRS Pharma: Single excipient, manyroles

The development of coprocessed, multifunctional excipients has enabled formulators to address multiple challenges with a single excipient, resulting in enhanced production and better finished product quality.

WhyPROSOLV® SMCC?

Attaining good hardness at low compaction forces is quite essential while considering suitability of excipient for tablet formulation. Microcrystalline cellulose is one of the widely used and accepted excipient in tablet dosage form. Compactability of microcrystalline cellulose (MCC) is of prime importance during compression.

MCC compact cohesion (which directly affects tablet strength) will be determined by the compaction pressure, all other conditions being equal.

PROSOLV® SMCC is a novel high-functionality tableting excipient. The material is manufactured by co-processing MCC with colloidal silicon dioxide (CSD) and can be used to improve flow, lubricant sensitivity and tablet strength.(1) (2) (3)

The addition of CSD in MCC helps improve compactability. It has recently been reported that silicification appears to have no apparent effect on the primary chemical and polymorphic characteristics of MCC. (4) This suggests that bulk modification of MCC does not occur during silicification and that the CSD, either by providing surface modification or by modifying strengthening interactions, is primarily responsible for the improvements in functionality, in particular tablet strength. This may be solely due to a morphological property or some other silicon dioxide MCC interfacial interaction.

Based on scanning electron microscopy studies together with electron microprobe analysis it was stated that silicon dioxide is primarily lo-

PROSOLV® SMCC is 30–50% percent more compactible than MCC.Therefore,the same hardness as observed with MCC tablets can be achieved with less compaction force.This results in more porous tablets which enables faster disintegration and more complete drug dissolution.

PROSOLV® SMCC also has approximatelyfive times the surface area of MCC,which in terms of blend quality, promotes better blending,homogeneity,dispersion,and overall content uniformity.

Belowimage compares tablets made with PROSOLV® SMCC 90 (left) and MCC+CSD (right).Blue pigment was added to the blending as a demonstration of content uniformity.In this example,PROSOLV® SMCC 90 promotes interactive blending and clearlycreates a more uniform blend.

cated at the surface of the SMCC particles, while certain amounts of silicon dioxide were detected in the internal regions of some particles, the colloidal silicon dioxide particles present at the surfaces of the SMCC particles are shown to be uniformly distributed. (5)

PROSOLV® SMCC for robust tablet production…

Taking the evolution of cellulose-based excipients further, JRS Pharma has improved MCC for direct compression by co-processing colloidal silicon dioxide and MCC in a spray-drying process. The result is PROSOLV® SMCC, which is almost dust free and flows significantly better than nondirect compression grade MCC. It also offers superior compactability as compared to regular grade MCC.

Effects of PROSOLV® technology

Silicification of MCC reduces the cohesiveness of the powder bed. Consequently it has much better powder flowability than traditional MCC grades of the same particle size leading to more manufacturing output via high speed tableting. Compared to traditional MCC the unique surface structure of PROSOLV® SMCC enables excellent blend homogeneity and content uniformity even for low dose micronized active pharmaceutical ingredient (API)

Benefits of using PROSOLV® SMCC

◆ PROSOLV® SMCC has superior flow and allows dust free handling

◆ Improves compressibility and helps in rapid formulation development

◆ Improved compactability is achieved leading to more robust tablets

◆ Provides hard compacts in

PHARMA PULSE

roller compaction

◆ Can be used for sticky, hygroscopic and compression sensitive API

◆ Excellent content uniformity in potent API can be achieved

◆ As co-processed has good solubility characteristics for insoluble API

◆ Frequently used in Multi unit particulates (MUPS) formulations

◆ Provides smaller tablet sizes as fewer excipients are needed at lower usage levels

Formulation examples using PROSOLV® SMCC technology

A) Low dose API formulation study:

A client was making a generic low dose levothyroxine product but was having content uniformity problems. The original product was mad with a MCC/lactose wet granulation process. In an attempt to improve content uniformity the company tried a direct compression blend with MCC 102 with little improvement.

The client then tried a direct compression blend with PROSOLV® SMCC 90 and saw immediate improvement in content uniformity. To achieve even better results the company made a pre-blend with 15% of PROSOLV SMCC 90 and geometrically blended it with the bulk of PROSOLV® SMCC. The content uniformity further improved and so did the % RSD.

Going a step further the client took the same pre-blend of API with PROSOLV® SMCC 90 of the requirement. They then blended it with PROSOLV® SMCC 50 & PROSOLV® SMCC 90 (50% each) to try and minimize the disparities which exist between the particle size of API and excipients. By using that formula and direct compression process achieved excellent content uniformity and % RSD of 0.08-0.1%

B) Reducing tablet size for a higher drug load

1) Formulation Challenge:

PROSOLV® SMCC 50 LD Best in class filler

PROSOLV® SMCC 50 LD Formulas in which optimal compaction and decent floware required

PROSOLV® SMCC 90 Formulas in which a balance of flowand compaction are required

PROSOLV® SMCC HD 90 Formulas in which optimal flowand consolidation are required.This grade shows the best disintegration time

PROSOLV® SMCC 90 LM Equivalent to PROSOLVSMCC 90 with lower moisture content (<3%)

Conclusion

PROSOLV® SMCC can be used by formulators to address challenges which occur due to conventional granulation processes. It serves as a multifunctional excipient enabling fast and simpler formulation development which is hassle free with proven benefits.

References

1) Sherwood, B. E., Hunter, E. A., Staniforth J. N. (1996) Silicified microcrystalline cellulose (SMCC): a new class of high functionality binders for direct tableting. Proc. AAPS Conf. PT 6164

2) Staniforth, J. N., Tobyn, M. J. (1996) towards a new class of high functionality tablet binders. III: Physical characteristics and particle morphology of silicified microcrystalline cellulose (SMCC). Proc. AAPS Conf. PT6162

3) Sherwood, B. E., Becker, J. W. (1998) a new class of high functionality excipients: silicified microcrystalline cellulose. Pharm. Tech. 22: 78-88

blend Direct compression blend with PROSOLV® SMCC 90

PROSOLV® pre-blend Pre-blend with 15% of SMCC 90 requirement 0.8-1.0%

PROSOLV® mixed grade pre-blend Pre-blend with 15% of PROSOLV® SMCC 90 requirement; titrated with 50/50 PROSOLV® SMCC 90 and PROSOLV® SMCC 50 0.08-0.1%

Exceptional tablet hardness Hardness 90-120 N Friability0.08%

Excessive tablet weight > 1800 mg

Lowbulkdensity,Active with poor flow

Significant segregation of active Fine particles seen floating on top of blend

The 19 active formulation including herbal constituents, required large amounts of both MCC and DCP to achieve workable compactability, yet still exhibited significant segregation, low content uniformity, and poor flow. The resulting tablet also exceeded target size due to multiple components

Target weight achieved < 1300 mg

Consolidated powder blend with excellent flow

Non- segregating formulation

Separation of fine particles reduced < 2 % RSD in tablet weight

and large amount of excipients.

2) Formulation results:

After formulating with PROSOLV® SMCC the need for Dicalcium phosphate was eliminated. Compactability, segregation and content uni-

formity were improved and tablet weight was reduced by 33%. Finally due to improved flow characteristics and consolidated blending, tableting speed and production efficiency both were increased.

4) Tobyn, M. J., McCarthy, G. P., Staniforth, J. N., Edge, S. (1998) Physicochemical comparison between microcrystalline cellulose and silicified microcrystalline cellulose. Int. J.Pharm. 169: 183-194

5) B. van Veena, G.K. Bolhuisb, Y.S. Wub, K. Zuurmanb, H.W. Frijlinkb (2005) Compaction mechanism and tablet strength of unlubricated and lubricated (silicified) microcrystalline cellulose. Eur. J. Pharmaceutics & Biopharmaceutics. 133-134

Author Mr. Suyesh Kale Technical Manager, JRS Pharma India

Email id: Suyesh.kale@jrsindia.com

PHARMA PULSE

NewAge docklevelers from Gandhi Automations

Gandhi Automation’s Dock Levelers are equipped with the most secure safety devices and accessories

Gandhi Automations –

India's No.1 Entrance Automation and Loading Bay Equipment Company.

This widely recognised position has been achieved over years of hard work, innovation, commitment to quality and reliable customer service. The company is also proud to be certified to EN ISO 9001:2015, EN ISO 14001:2015 & ISO 45001:2018 by TÜV Austria.

Since inception in 1996, Gandhi Automations has been manufacturing, importing, distributing and installing products that are problem-free and easy to operate.

The company offers complete logistics solutions, by providing Dock Levelers, Dock Shelters, Sectional Overhead Doors and Dock Houses.

Electro-hydraulic Dock Levelers offered by Gandhi Automations are not only 'a bridge for connecting a vehicle‘, but also facilitate fast, smooth and safe transition by compensating the difference in heights between the loading bay and the vehicle. This contributes to minimising energy use and savings on heating and chilling costs, resulting in maintaining the quality of the transported goods. Dock Levelers offered by Gandhi Automations are designed per EN 1398 standard for the most demanding loading and unloading operations.

Efficient loading and unloading the goods

The importance of efficient loading the goods has always been evident, and it has increased over the years, essentially for two reasons: the lesser availability and the higher cost of manpower. Consequently lesser qualified manpower is being utilised, which leads to damage to the goods.

The cost of loading and unloading the goods can be calculated precisely and is exactly definable, which allows for a

scientific approach to find out the investment that goes in the process. Gandhi Automations has always designed solutions based on such a scientific approach and feedback from clients. The Dock Levelers offered by the company ensure loading and unloading with lesser effort and minimal cost. It is possible to load and unload your products in a safe way and in the process obtain remarkable energy savings. The Dock Leveler remains with the Loading Bay in rest position and the Sectional Overhead Door closed, until the vehicle is positioned. The driver drives back, turning to the Dock Shelter, and stops the vehicle the moment it gets in contact with the bumpers.

The Sectional Overhead

Door is then opened only when the vehicle is positioned, brakes are applied and the engine is shut off. This eliminates the exit of hot air, intake of cold air (or the opposite in hot area and inside conditioned places) and intake of exhausting gases in the warehouse. After the Sectional Overhead Door opens, the lip of the Dock Leveler connects to the truck bed for loading/unloading to take place.

At the end of the loading/unloading, the Dock Leveler is put in restposition and the Sectional Overhead Door is closed, without moving the vehicle. The vehicle then departs at the end of the process. Following are the two types of Dock Levelers.

a) Radius Lip Dock Levelers

Radius Lip Dock Levelers

Since inception in 1996,Gandhi Automations has been manufacturing,importing, distributing and installing products that are problem-free and easy to operate

are available in multiple sizes and capacities. It allows the dock to connect with the truck bed, thus making it convenient to drive directly on and off with forklift trucks, etc. Also, the self-cleaning lip-hinge system does not retain dust or dirt, which allows a smooth operation.

b) Telescopic Lip Dock Levelers

Telescopic Lip Dock Levelers are ideal for connecting vehicles unable to drive near docks, i.e., sea containers, side loading railway wagons, etc. These dock levelers can be supplied with a lip extending up to 1 m.

c) Edge-of-Dock Levelers

Edge-of-Dock Leveler is developed in compliance with the latest European safety standard, EN 1398. It has a capacity of 6000 kg and is suitable for use with all types of material handling equipment.

d) Forklift Roll-off Barrier

Lip Dock Levelers

The newly introduced product, Forklift Roll-Off Barrier Lip Dock Leveler, adds run-off protection that prevents accidental forklift roll-off when the overhead door is open and no trailer is stationed at the dock. These dock levelers are designed and built to provide all the benefits of the hydraulic dock leveler, along with the additional benefit of providing a formidable barrier.

Gandhi Automation’s Dock Levelers are equipped with the most secure safety devices and accessories.

For further details, contact: Gandhi Automations

Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064, India

Off : +91 22 66720200 / 66720300

Fax: +91 22 66720201

Email : sales@geapl.co.in

Website: www.geapl.co.in

PHARMA PULSE

Complete environmental monitoring solution – testo Saveris Pharma

testo Saveris Pharma monitors and documents temperature,humidity,differential pressure,and other parameters without interruption and compliantly with GxPso that audits and inspections are conducted smoothly

There are several critical applications in the industry like research and development that demand for continuous and reliable monitoring of important environmental parameters. From medical, bio-technical, chemical and pharma laboratories to cleanrooms, biobanks up to blood and tissue banks, a holistic monitoring system is very necessary which reliably records different measurement parameters in these rooms and at equipment. Wherever there is a need to adhere to necessary standards, ensure traceability and audit compliance, especially pharma, these solutions become crucial in the facility operation.

The most efficient way to address this requirement is the implementation of fully automated environmental monitoring system testo Saveris Pharma. It monitors and documents temperature, humidity, differential pressure, and other parameters without interruption and compliantly with GxP so that audits and inspections are conducted smoothly. As a complete solution, testo Saveris Pharma combines:

◆ High-precision measurements with secured data communication

◆ Intuitive and pro validation software

◆ Comprehensive services.

◆ The system consists of following components

Data logger and communication modules

Data loggers are the components that measure/log the data continuously at different locations in the facility. They communicate with the base unit to transfer the recorded data. Because there are numerous tasks to fulfil in research and development, there are various models of data logger to measure different pa-

rameters. Another important task is data transfer and for that communication modules are used. Each data logger can be flexibly connected to one of the three communication modules.

◆ WLAN Module

◆ LAN Module

◆ Radio via Testo Ultra range communication Module testo UltraRange ensures that a strong and robust radio signal is available even over long distances or in closed rooms. All data loggers can be exactly calibrated, and depending on the model, can record temperature and relative air humidity. As per the applications, data loggers are selected for environment monitoring for warehouse, analytical/microbiology lab, animal house or equipment monitoring like refrigerator, freezer, chiller, walk in chamber, etc.

The base station

The base is literally the heart of testo Saveris Pharma sys-

tem. It can connect with 1000 different Data Loggers at a time. It collects measurement values and analyse it limit value violation or any other critical event occurs. It plays an important role in prompt alarm management. The base unit can be positioned centrally at a given facility location or office. Base station delivers alarms to users via an alarm relay and an LTE stick that enables alarms by SMS as well in addition to visual and audible alarms.

Digital and analog sensors

The instrumentation utilised to measure parameters like temperature and humidity is in the form of variety of digital and analog sensors that are easy to handle and install. The Digital sensors has advantage over analog sensors as it can be quickly exchanged during continuing operation for calibration or defect correction. Calibration of Digital Sensor is

independent of its Logger. Thus, it ensures no gap in the measurement values or documentation. The measuring ranges of the temperature probes extends from -200 °C to +1300 °C, covering almost any possible scenario in the field of research & development.

The integration of other measurement parameters such as differential pressure, particles etc. also work smoothly with the analog coupler as a standardised interface.

System software

Once the data is recorded by Loggers and analysed by the base station, the testo Saveris Pharma software comes into play where all readings are collated, stored, visualized, and backed up seamlessly. Automatic reports are generated and sent over email to concerned users. Some important features are applied like electronic signature, Electronic Record, Access Control, Audit Trail, Alarm Logs. There are two versions of the testo Saveris software; testo Saveris PRO software- It is suitable for the automated and uninterrupted data monitoring with less stringent regulations, normally other than Pharma Industry. testo Saveris CFR software – It guarantees unconditional adherence to US 21 CFR Part 11 as well as Annex 11 of the EU guidelines for GMP. In addition to the range of function of the PRO version, it offers Audit

Trail and electronic signatures.

In addition, we provide Web access to the data with testo Saveris Pharma Cockpit - a web based and intuitive user interface which allows data access from different end devices. Alarms can be identified and acknowledged via a smartphone, tablet or PC at any time. It also supports features like digital signature post any action as well as a mandatory comment on the event.

Comprehensive services

The most important aspect of any solution is after sales service. This is one of the strongest values offered by Testo to its customers. Testo extends its support from site survey, Installation commissioning, IQOQ documentation to annual maintenance work and recalibration. So, all the end-to-end services are offered under one roof as an OEM by Testo. Thus, user do not have to run pillar to post to get support, Testo ensures rich user’s experience throughout life cycle of the system.

Areas of application

◆ Area monitoring in labs, production, warehouse, animal house in pharma

◆ Equipment monitoring for QA/QC, microbiology in pharma

◆ Clean room area monitoring in pharma

◆ Refrigeration and deepfreezer applications in pharma

◆ Uninterrupted cold chain monitoring and controlled freezing in blood and bio banks

◆ Applicable for lab equipment from laboratory extractor to water bath

◆ Data centre area monitoring

◆ Calibration and testing lab area monitoring

For more details, login to www.testo.com or write to info@testo.in

PHARMA PULSE

Yokogawa Helps to Revolutionize the Field of Single-Cell Lipidomics

Yokogawa Electric Corporation’s latest singlecell analysis solution, the Single Cellome™ System SS2000, has been featured in an article published in the highprofile journal Analytical Chemistry regarding groundbreaking work conducted by researchers at the University of Surrey in the emerging field of single-cell lipidomics*1. The SS2000 is a live cell image device equipped with Yokogawa’s original dual-microlens spinning disk imaging technology, and enables cutting-edge life science research.

*1 Single-Cell Untargeted Lipidomics Using Liquid Chromatography and Data-Dependent Acquisition after Live Cell Selection | Analytical Chemistry:

https://pubs.acs.org/doi/10.1021/a cs.analchem.3c05677

Lipidomics is the large-scale study of lipids, a large family of molecules that play biological roles ranging from maintaining normal operation of the human body to the development of major diseases*2. Lipidomic studies are conventionally conducted by bulk isolation and analysis of lipids from many cells. While bulk lipid analyses can provide scientists a population average of the lipid pro-

file, they are unable to discern subtle cell-to-cell variations or reveal the spatial or temporal differences to the lipidome caused by cell-cell interactions. Single-cell lipidomics is an emerging field where the lipid composition of single cells is analyzed. These studies help overcome the challenges of bulk lipidomics by offering scientists a means of exploring spatial and temporal differences in addition to intercellular variability. Understanding

these differences is key to creating a more complete picture to understand diseases such as cancer*. One challenge facing researchers is the ability to isolate single cells in a way that maintains the natural lipidome of a cell. Current methods of single-cell isolation detach and suspend multiple cells at once and then isolate them through a narrow channel, but this can be particularly stressful to cells and may result in alterations to cellular lipid make up. Yoko-

gawa’s Single Cellome System SS2000 uses confocal imaging technology to help abrogate challenges with single-cell lipidomics. It is a dual-purpose system that enables live cell imaging and also performs fully automated single-cell and subcellular sampling without going through the suspension process, thereby minimizing stress on the cells.

Yokogawa’s collaborators at the University of Surrey have shown that Yokogawa’s SS2000 is a vast improvement over other single-cell isolation technologies in the context of single-cell lipidomics. With the ability to sample adherent cells in culture, the SS2000 has allowed researchers to maintain the natural lipid profile of sampled cells while also providing spatial and temporal information based on real time imaging. The researchers have taken advantage of this unique dual capability to create a workflow that is not feasible with other technologies. They have coupled the spatial and temporal information gained from the SS2000’s dual-microlens spinning disk imager with liquid chromatography mass spectrometry data conducted on each sampled cell. This novel approach is a radical step forward in the field of

lipidomics, which will help lead to breakthroughs in alternative treatments and therapies for cancer, diabetes, and cardiovascular disease*.

In this way, Yokogawa will continue to provide our customers with new value and the latest technology, and help ensure well-being for all.

*2 Zehua Wang, Mingjun Cao, Sin Man Lam, Guanghou Shui. Embracing lipidomics at single-cell resolution: Promises and pitfalls. TrAC Trends in Analytical Chemistry, Volume 160, 2023, 116973, ISSN 01659936, https://doi.org/10.1016/j.trac.202 3.116973.

For more information

New cancer research made possible as Surrey scientists study lipids cell by cell | University of Surrey: https://www.surrey.ac.uk/news/ new-cancer-research-madepossible-surrey-scientistsstudy-lipids-cell-cell

Single Cellome™ System

SS2000: https://www.yokogawa.com/solutions/productsand-services/life-science/single-cellome/ss2000/

The names of corporations, organizations, and products herein are either trademarks or registered trademarks of their respective holders.

Image 1.Single Cellome System SS2000

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