Feb 2020 - Mar 2020

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Vol - 14 Issue - 6

Feb - March 2020 PUBLISHER & EDITOR

Harjit Singh Dhaul Editorial Office Global Vision 26-B, Rebellow Cottage, Gaon Devi Road, Poinsur (E), Kandivli 400 101 E-mail:info@pharmamachines.com Advertisement/Circulation/ Subscription enquiries: Tel: 28701520 Fax: 28701848 E-mail:info@pharmamachines.com Website: www.pharmamachines.com All rights reserved. Reproduction in any manner is prohibited. PHARMA Machines & Technology takes no responsibility for validity of claims in advertisement and articles published. Printed & Published by Harjit Singh Dhaul on behalf of Global Vision and printed at Hariom Printers C/70, Akurli Industrial Estate, Akurli Road, Kandivali East, Mumbai 400 101, and published at 26-B, Rebellow Cottage, Gaon Devi Road, Poinsur (E), Kandivli 400 101. Editor: Harjit Singh Dhaul. DEPUTY EDITOR


Ravlin Kaur COVER DESIGN Ki Ideas

Pharma Machines & Technology Bimonthly Update on Quality Movement...

DEAR PHARMA PALS: The exclusive in this issue of Pharma Machines & Technology presents industry and regulatory perspectives on the control of genotoxic and elemental impurities in pharmaceuticals.

The exclusive is based on the presentation by Dr. Atul Awasthi, Director - GTS MSAT AS, Pfizer, at the 8th Annual Global Pharma Regulatory Summit by CPhI Conferences. Dr. Atul Awasthi summarises the discussion on genotoxic impurities as control, scientific knowledge, and compliance. Control of PGI's is one of the main reasons for major deficiencies in DMF's. Following ICH M7 step by step could make control of PGI's right first time. In depth understanding of the formation, fate and purge will facilitate selection of appropriate control strategy. This will reduce the assessment time and increase the chance that the DMF will become adequate with in ANDA first cycle review clock. Compliance with ICH M7 is required in post approval submission. The ICH M7 Appendix-1 provides applicable scope scenarios. According to Dr. Atul Awasthi, the most significant challenges for the industry is the practical implementation of ICH Q3D guideline. Elemental impurity assessment presents new challenges which include determining how to assess or quantify the risks associated with factors such as water, container-closure systems and excipients. Defining where in the assessment process data may be required and identifying where risks can be determined to be negligible through a thorough scientific theoretical risk assessment also present significant questions. Requirement of costly and sophisticated instrument is also a challenge, especially for small scale companies. Starting this issue we have introduced a new column by the name 'Discussion' wherein industry experts speak on various topics. Creating an agile environment to support sustainable growth is the topic of the first instalment. Read on... Harjit Singh Dhaul

Publisher & Editor




Control of Genotoxic & Elemental Impurities Industry & Regulatory Perspectives 18 Based on the presentation by Dr. Atul Awasthi, Director - GTS MSAT AS, Pfizer, at the 8th Annual Global Pharma Regulatory Summit by CPhI Conferences.

Discussion Creating an Agile Environment to Support Sustainable Growth From the panel discussion at Pharma Project & Portfolio Management Summit 2020

Dock Seals Vs Dock Shelters


Reviews CPhI & P-MEC India 2019 Pharma Project & Portfolio Management Summit 2020 Pharma Authors Roundtable 10th Edition of PharmaTech & LabTech Expo

54 44 48 60

Preview 36

11th edition of pharma and lab expo



India Pharma

News & Updates

How coronavirus pandemic can affect India pharma Regulation led to increase in price of essential drugs According to the Economic Survey for 2019-20, the government's move to regulate prices of essential drugs have actually led to increase in their cost when compared to similar drugs that remained unaffected by the price control. The data was analysed for 1751 formulations and 49893 brands and showed that prices of drugs that came under Drugs Price Control Order (DPCO), 2013 increased on an average by Rs 71 per mg of the active ingredient, whereas the prices increased by Rs 13 per mg of the active ingredient for those unaffected by the price control. Prices of those formulations, under price control, sold in hospitals increased as much as Rs 99 per mg, while those formulations which were not under price control and sold in hospitals, increased by only Rs 25 per mg.

Likely to grow at 10-13 per cent in FY'21 According to rating agency Icra, Indian pharmaceutical industry is likely to grow at 10-13 per cent in 2020-21 despite challenges. The expected growth in the next financial year is on the back of healthy demand from the domestic market given increasing spend on healthcare along with improving access. This along with abatement in pricing pressure for the US market, new launches and market share gains for existing products and consolidation benefits will drive growth. Though margins remain healthy, pricing pressures for the US base generics business (albeit moderating), lack of limited competition products and manufacturing quality issues will continue to put margin pressure. The key sensitivities to growth and profitability estimated of the Indian pharma industry will be regulatory interventions such as price controls and compulsory genericisation for domestic market and continued regulatory overhang with respect to manufacturing quality deficiencies during USFDA audits.

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India, the world's third-largest drug producer by volume, imports 70% of its raw materials from China. This may slowdown drastically if the restrictions in the neighbouring country continue for long. China's decision to extend the Lunar New Year holidays and the quarantine of more than 45 million could make imports of key raw materials difficult. Companies including Lupin, Sun Pharmaceuticals, Glenmark, Mankind, Dr Reddy's, Torrent, Aurobindo Pharma and Abbott are hugely dependent on Chinese imports. The problem for the Indian industry has been compounded by the fact that much of Chinese drug raw material production is concentrated in Hubei, whose capital is Wuhan, the epicentre of the coronavirus outbreak.

18% of product launches to be delayed in US Rating agency Crisil predicts that 18% of launches by Indian generic companies will be delayed in the US due to the regulatory action by the US Food and Drug Administration (USFDA). The warning letter issued by USFDA to large pharma companies more than doubled in the first 10 months of 2019 compared with the previous year. Close to 180 generic drug launches will be pushed out from their intended launch dates due to it. According to Crisil, regulatory action in the US could bring down the US growth of Indian companies to 10-11% from the current 16% in the next two years.

India Pharma

News & Updates

Marketers responsible for drugs made by third parties

India to work on vaccines for coronavirus

As per the notification issued by the health and family welfare ministry, pharmaceutical companies that market medicines made by third parties in the country will now be held responsible for drug product quality.

The Department of Biotechnology (DBT) is partnering with the Norway-based Coalition of Epidemic Preparedness and Innovations (CEPI) to fund development of vaccines for the novel coronavirus (Covid-19).

The move will impact many big domestic and multinational pharmaceutical companies that get their medicines manufactured by smaller companies. At present, there is no liability on them for any defect in a drug. Under the Drugs and Cosmetics Rules, only the manufacturer is held responsible for spurious or substandard drug. The marketing companies just require a license to sell their drugs. Once the new rules come into effect from March 2021, the drug regulator can also penalise the marketing companies in case of spurious or substandard medicines. Contraventions to the rules can attract penal punishment of 3-5 years of imprisonment in case the drug is not of standard quality, or life imprisonment in cases where they are found to be spurious.

To reduce dependence on imports of antibiotic raw materials Government is taking steps to reduce country's dependence on imports of antibiotic raw materials. The quantity of raw materials imported for the formulation of antibiotic medicines was reduced to 11,230.50 metric tonne in 2019, as the government has undertaken various steps to promote the production in the country. As per the information from the port offices of the Central Drugs Standard Control Organisation (CDSCO), it stood at 12,006.11 metric tonne (MT) for 2018 and 5,591.44 MT in 2017. The Department of Pharmaceuticals has formulated a scheme, namely 'Assistance to bulk drug industry for common facility centre', for providing assistance to bulk drug segment.

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The DBT under the India chapter of the CEPI will support Indian companies aligned to the development of vaccines against the Covid19 and other emerging infectious diseases. DBT is putting together a network of organisations globally who are working on better diagnostics to detect the infection and also possible monoclonal antibodies.

Medical equipment used on humans or animals as drugs The Union Health Ministry has notified medical equipment used on humans or animals as "drugs" with effect from April 1, 2020, which means that now all imported, as well as locally manufactured medical devices sold in India will be required to clear specific safety and quality standards. Medical equipment include all implantable medical devices, CT scan, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator. Once notified, import, manufacture and sale of all medical devices will need to be certified by the Central Drugs Standard Control Organisation (CDSCO). Manufacturers will also have to seek licences from the Drug Controller General of India (DCGI). Besides it will also make medical device companies accountable for quality and safety of their products.

Global Pharma

News & Updates

vaccine development programmes to advance candidates into clinical testing.

Two new drugs may help treat coronavirus A research team at Zhejiang University in China have found that two drugs, Abidol and Darunavir, may help treat patients infected with the new coronavirus. Preliminary in-vitro testing showed the drugs to be effective in blocking the virus. The team is led by Zhejiang University professor Li Lanjuan, who said that the currently used anti-HIV drug Kelizhi does not exhibit adequate effectiveness and has side effects. Lanjuan calls for the addition of the two new drugs in China National Health Commission's programme for the treatment of pneumonia caused by the new coronavirus. Chen Zuobing, a researcher from the team, noted that Abidol and Darunavir were used to treat patients infected by the virus in Zhejiang Province. Last month, Chinese researchers have selected to test 30 drug candidates for potential therapeutic effects against the Wuhan coronavirus. The selected candidates include 12 HIV medicines, two respiratory syncytial virus drugs, a schizophrenia medication and an immunosuppressant, along with some traditional Chinese medicines.

UK commits £20m to develop vaccines The Government of UK has committed £20m to develop vaccines for the coronavirus, as well as other infectious diseases. The £20m funding will also be used to support the development of diagnostics and cures to address the threat of viruses in the future. The UK is providing these funds to CEPI. Funding will be used for three coronavirus

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Meanwhile, a UK scientist has claimed to fast track development of coronavirus vaccine. The scientist Robin Shattock said his research team was able to reduce a part of the development timeline from the standard two to three years to 14 days. This development is part of a global effort to develop a vaccine to address the ongoing coronavirus outbreak. It is estimated that a vaccine would take at least a year to be commercially available.

Coalition for Epidemic Preparedness Innovations GlaxoSmithKline (GSK) has partnered with the Coalition for Epidemic Preparedness Innovations (CEPI) to aid the development of a vaccine against the new coronavirus. As part of its alliance with the CEPI, GSK will provide access to its pandemic vaccine adjuvant platform technology to help speed-up the development of coronavirus vaccine candidates. Certain vaccines consist of an adjuvant to boost the immune response against infections. In a pandemic, an adjuvant can be useful as it can decrease the amount of antigen per dose, enabling the manufacture of more vaccine doses, noted GSK. The coalition will manage any arrangements between any CEPI-funded entities who want to test their vaccine platform with GSK's adjuvant technology to create coronavirus vaccines. The University of Queensland in Australia signed the first deal for GSK's technology. In addition to the University of Queensland, CEPI is funding 2019-nCoV vaccine programmes by CureVac, Inovio Pharmaceuticals and Moderna, which is working with the US National Institute of Allergy and Infectious Diseases.

Global Pharma

News & Updates

EMA announced support to speed-up development The European Medicines Agency (EMA) has announced support to speed-up the development of vaccines and treatments for the new coronavirus that emerged in Wuhan, China. EMA is calling for the development of preventives and treatments. The agency will offer support to drugmakers to accelerate both the increase and availability of medicinal products. The agency is drawing on the strong expertise of the European medicines network to provide fasttrack scientific advice and give prompt feedback on any proposed medicine developments. The scientists at Public Health England (PHE) in the UK have completely sequenced the genome of the new coronavirus. The sequence offers insights into the mutation of the virus over time and its spread.

Alliance to develop coronavirus drugs Regeneron Pharmaceuticals has expanded its ongoing partnership with the US Department of Health and Human Services (HHS) for the development of treatments to combat the new coronavirus, 2019-nCoV. The company will work with the Biomedical Advanced Research and Development Authority (BARDA) at HHS' Office of the Assistant Secretary for Preparedness and Response (ASPR) to create several monoclonal antibodies targeting the virus. Regeneron's monoclonal antibody discovery platform, VelocImmune, will be leveraged to develop the monoclonal antibodies, which attach to a virus' proteins and reduce its ability to infect human cells. VelocImmune is part of the company's VelociSuite technology, previously leveraged to develop a three-antibody therapeutic to fight the ongoing Ebola outbreak in the Democratic Republic of the Congo.

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Furthermore, the technology was used for a two-antibody therapeutic to treat Middle East Respiratory Syndrome coronavirus (MERSCoV), cutting the development time from years to months. VelociSuite reduced the time taken for antibody discovery and selection, preclinical-scale manufacturing and clinical-scale manufacturing, among other drug development stages. HHS and Regeneron signed an agreement in 2017 to discover, research, develop and manufacture antibodies targeting up to ten pathogens, now including the new coronavirus and influenza virus.

Emory University's drug candidate may help Emory University in the US has announced that an antiviral drug candidate, EIDD-2801, may help treat patients with new coronavirus. The university's wholly-owned non-profit unit Drug Innovation Ventures at Emory (DRIVE) is developing the drug candidate. EIDD-2801 is an oral ribonucleoside analogue, which blocks RNA viral replication in influenza, Ebola, respiratory syncytial virus and chikungunya. The University of North Carolina and Vanderbilt University Medical Center tested the drug candidate. Findings reveal that its active form, EIDD-1931 demonstrates efficacy against Severe Acute Respiratory Syndrome (SARS) and the Middle East Respiratory Syndrome Coronavirus (MERSCoV) viruses, related to the new virus. Funds from the National Institute of Allergy and Infectious Diseases (NIAID) supported the development of EIDD-2801. Based on the drug's broad-spectrum activity against viruses including influenza, Ebola and SARS-CoV / MERS-CoV, it is believed that it will be an excellent candidate.


Facts & Figures

DID YOU KNOW? India's pharmaceutical industry is expected to expand at a compound annual growth rate (CAGR) of 22.4% in 2015–20 to reach $ 55 billion. According to WHO, non-communicable diseases such as cancer, diabetes, and cardiovascular diseases have been collectively responsible for 70 per cent of all deaths worldwide. Vildagliptin, a class of medication called dipeptidyl peptidase IV (DPP4) inhibitors, has about 25% share of the Indian gliptins market of Rs. 3,600 crore. Over 68 per cent of cancer patients, over nearly two-thirds of cancer patients, are dying in India. The market size for chronic Hepatitis B in India is estimated at Rs 140-crore. According to USFDA's definitions, OAI (official action indicated) means "objectionable conditions were found and regulatory administrative sanctions by FDA are indicated" during inspections. According to Pharmexcil, India imported Rs. 17,400 crore worth of APIs from China in FY 2019. Raw materials from China are used in making antibiotics, paracetamol, and diabetes and cardiovascular drugs, among others. About 90% of the needs of antibiotic makers in India is fulfilled by China. According to India's drug regulatory body, the country has 1,500 plants that manufacture APIs. The Ahmedabad-based company Torrent Pharmaceuticals is the only domestic pharma company that has invested nearly $1 billion in local acquisition over the last three years. Wockhardt employs more than 7,000 people and has a presence in the US, Britain, Ireland, Switzerland, France, Mexico, Russia and other countries. It has manufacturing and research facilities in India, the US and Britain, and a plant in Ireland. As per an August 2019 research report by ICICI Securities, Cipla currently has a 5% share of the domestic formulations business. Spending on medicines in India is projected to grow 9-12% over the next five years, putting it in the top 10, according to the Indian Brand Equity Foundation's October 2019 report on the country's pharmaceutical sector. Indian pharma companies total sales from the US market is estimated to be Rs 55 thousand crore.

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Control of Impurities

Control of Genotoxic and Elemental Impurities Industry & Regulatory Perspectives Based on the presentation by Dr. Atul Awasthi, Director GTS MSAT AS, Pfizer, at the 8th Annual Global Pharma Regulatory Summit by CPhI Conferences, a division of UBM India.

What are impurities? Impurities are unwanted chemicals present in the drug substance (DS) or drug product (DP) arising from normal manufacture. Examples: Starting materials and by-products from DS synthesis; components resulting from the DS and excipient interaction. Organic impurities (process and drug related): Starting materials; by-products; intermediates; degradation products; reagents, ligands, catalysts; and geometric and structural isomers. Inorganic impurities: Reagents, ligands, catalysts filter aids, charcoal etc.; heavy metals and other residual metals. Residual solvents: Vehicles used in synthesis and purifications / formulation process.

Genotoxic Impurities – ICH M7 ICH M7 Assessment and control of DNA reactive (mutagenic) im-

18 PHARMA machines & technology

purities in pharmaceuticals to limit potential carcinogenic risk. This guideline emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in final drug substance or product, taking into consideration the intended conditions of human use. ICH M7 guideline is intended for new DS and DP for clinical development and marketing applications; current marketed products; and impurities in excipients that are used for the first time in a drug product and are chemically synthesized. Changes to the drug substance Feb - March 2020

synthesis result in new impurities or increased acceptance criteria for existing impurities. Changes in the formulation, composition or manufacturing process result in new degradation products or increased acceptance criteria for existing degradation products. Changes in indication or dosing regimen are made which significantly affect the acceptable cancer risk level. Threshold of Toxicological Concern Threshold of Toxicological Concern (TTC) is a key concept in ICH M7. TTC is developed to define an acceptable intake for


Control of Impurities

have the potential to cause cancer. High potency mutagenic carcinogens are controlled at/below compound specific acceptable limit.

hysterectomy) treatment, fracture healing (these are acute use but with long half-lives). Treatment duration of > 1 10 years: e.g., stage of disease with short life expectancy (severe Alzheimer's), non-genotoxic anticancer treatment being used in patient population with longer term survival (breast cancer, chronic myelogenous leukemia), drugs specifically labelled for less than 10 years of use, drugs administered intermittently to treat acute recurring symptoms (chronic Herpes, gout attacks, substance dependence such as smoking cessation), macular degeneration, HIV.

Acceptable Intake Treatment duration needs to be considered for applying acceptable intake. Treatment duration should be located in RLD label. Alternatively, refer to treatment durations based on clinical use scenarios (ICH M7, Note 7). Following are acceptable intakes for an individual impurity. Acceptable intakes for multiple impurities are slightly different. Duration of treatment

≤1 month

Daily intake (μg/day)


>1–12 months

>1-10 years

>10 years to life time




Treatment duration of ≤ 1 month: e.g., drugs used in emergency procedures (antidotes, anaesthesia, acute ischemic stroke), actinic keratosis, treatment of lice. Treatment duration of > 1 – 12 months: e.g., anti-infective therapy with maximum up to 12 months treatment (HCV), parenteral nutrients, prophylactic flu drugs ( ~ 5 months), peptic ulcer, Assisted Reproductive Technology (ART), pre-term labour, preeclampsia, pre-surgical

20 PHARMA machines & technology

Treatment duration of > 10 years to lifetime: e.g., chronic use indications with high likelihood for lifetime use across broader age range (hypertension, dyslipidemia, asthma, Alzheimer's (except severe Alzheimer's disease), hormone therapy (e.g., growth hormone, thyroid hormone, parathyroid hormone), lipodystrophy, schizophrenia, depression, psoriasis, atopic dermatitis, Chronic Obstructive Pulmonary Disease (COPD), cystic fibrosis, seasonal and perennial allergic rhinitis. Feb - March 2020

A TTC-based acceptable intake of a mutagenic impurity of 1.5 µg per person per day is considered to be associated with a negligible risk (theoretical excess cancer risk of <1 in 100,000 over a lifetime of exposure) and can, in general, be used for most pharmaceuticals as a default to derive an acceptable limit for control. This approach would usually be used for mutagenic impurities present in pharmaceuticals for long-term treatment (> 10 years) and where no carcinogenicity data are available (Classes 2 and 3).

ICH M7 Classification of Impurities Class 1: Known mutagenic carcinogens. Class 2: Known mutagens with unknown carcinogenic potential (bacterial mutagenicity positive*, no rodent carcinogenicity data). *Or other relevant positive mutagenicity data indicative of DNA-reactivity-related induction of gene mutations (e.g., positive findings in in vivo gene mutation studies). Class 3: Alerting structure, unrelated to the structure of the drug substance; no mutagenicity data. Class 4: Alerting structure, same alert in drug substance or compounds related to the drug substance (e.g., process intermediates) which have been tested and are non-mutagenic.


Class 5: No structural alerts, or alerting structure with sufficient data to demonstrate lack of mutagenicity or carcinogenicity.

(Q)SAR Systems A (Q)SAR (Quantitative structure–activity relationship) model can estimate the relationship between the structure of chemical substances and another property, e.g. the substance's ability to cause toxic effects. (Q)SAR models can therefore be used to predict the properties of substances that are harmful to the environment or health. For Phase 2b and Phase 3 clinical development trials, a list of the impurities assessed by (Q)SAR should be included, and any Class 1, 2, or 3 actual and potential impurities should be described along with plans for control. The in silico (Q)SAR systems used to perform the assessments should be described. The results of bacterial mutagenicity tests of actual impurities should be reported.

Control of Impurities

Combination of two (Q)SAR Tools to predict Ames Mutagenicity Company

QSAR Tools

A. 608 chemicals (25% positive)





























B. 269 chemicals (14% positive)

C. 119 chemicals (31% positive)

Sensitivity Specificity Concordance (%) (%) (%)

the large body of Ames data and the strong correlation between chemical structure and Ames mutagenicity. Ames results are important for decisions on the development of chemical products and pharmaceuticals and the assessment of chemical safety, given that a positive result corresponds to increased cancer risk from exposure to the chemical even at a low level.

The ICH-M7 guideline currently recommends two QSAR models (expert rule-based and statistical) to predict Ames mutagenicity for AMES/QSAR International initially assessing DNA-reactive Collaborative Study impurities in pharmaceuticals. Robust QSAR models defining This is the first international toxicological endpoints are deguideline addressing the use of sirable to enable regulatory auQSAR in lieu of an actual toxicothorities to identify chemicals pos- logical study for human health sibly causing adverse effects with- assessment. Thus, QSAR models out performing actual toxicologi- for Ames mutagenicity now recal studies. Much effort has been quire much greater prediction invested in the development of power to ensure the safety of QSAR models to predict Ames chemicals. To increase this premutagenicity, among many toxidiction power, experimental data cological endpoints, to exploit sets as training data to build the

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models are important. Large numbers of highly reliable data sets will allow development and improvement of QSAR models with high predictive power. The Division of Genetics and Mutagenesis, National Institute of Health Sciences (DGM/NIHS) has Ames mutagenicity data for approximately 12,000 new chemicals. The Ames assays were conducted according to the OECD TG471 guideline and Industrial Safety and Health Act in Japan under GLP-compliant conditions. DGM/NIHS now provides these Ames data to QSAR builders/vendors to improve their QSAR models for predicting Ames mutagenicity with the permission of the Industrial Safety and Health Department of the Ministry of Health, Labor and Welfare (MHLW), Japan. The Ames/QSAR international collaborative study leaded by DGM/NIHS was launched on 2014. Because most of the Ames data are confidential, the


QSAR builders/vendors participating in the project must execute a confidentiality agreement. Twelve QSAR builders/vendors from USA, UK, Italy, Spain, Bulgaria, Sweden, and Japan are currently participating in this project. Chemical Classes in Industrial Chemicals (CPPB) and Expected Chemicals as impurities

Industrial Chemicals: Aromatic amine or amide, N=Nitro or N-nitroso compound, Aromatic nitro compound, Alkylating agent, Aromatic azo compound, Epoxide, Halogenated alkene, Misc Alerts (<5). Expected Chemicals as impurities: Alkylating agent, Aromatic amines, amides, and N-hydroxylamines, Aromatic nitro derivatives, Acid chloride derivatives, Alkyl aldehydes, Hydrazine derivatives, Boronic acids, Misc Alerts (<20).

Control Strategy A control strategy is a planned set of controls derived from current product and process understanding that assures process performance and product quality. A control strategy can include, but is not limited to, the following: Ÿ Controls on material attributes

(including raw materials, starting materials, intermediates, reagents, solvents, primary packaging materials); Ÿ Facility and equipment operat-

ing conditions; Ÿ Controls implicit in the design

24 PHARMA machines & technology

Control of Impurities

Reviewer's Checklist Stage Prior to assessment



Reviewer's Checklist 1. Conclusion 2. Locate Treatment duration and MDD in RLD label 3. Identify Acceptable intakes and calculate TTC 1. Identify alerting structures based on synthetic route 2. Search internal (Q)SAR database and submit internal (Q)SAR request 3. Submit Pharm/Tox consult if Ames test report provided (3 months) 4. Submit ComTox consult if (Q)SAR report provided (2 weeks) 5. If Control Options of ICH M7 adopted, assessment is Immediate. 1. Conclude the assessment and cite appropriate deficiency

of the manufacturing process; Ÿ In-process controls (including

in-process tests and process parameters); Ÿ Controls on drug substance

and drug product (e.g., release testing). There are 4 potential approaches to development of a control strategy for drug substance: Option 1: Include a test for the impurity in the drug substance specification with an acceptance criterion at or below the acceptable limit using an appropriate analytical procedure. Option 2: Include a test for the impurity in the specification for a raw material, starting material or intermediate, or as an in-process control, with an acceptance criterion at or below the acceptable limit using an appropriate analytical procedure. Option 3: Include a test for the Feb - March 2020

impurity in the specification for a raw material, starting material or intermediate, or as an in-process control, with an acceptance criterion above the acceptable limit of the impurity in the drug substance, using an appropriate analytical procedure coupled with demonstrated understanding of fate and purge and associated process controls that assure the level in the drug substance is below the acceptable limit without the need for any additional testing later in the process. Option 4: Understand process parameters and impact on residual impurity levels (including fate and purge knowledge) with sufficient confidence that the level of the impurity in the drug substance will be below the acceptable limit such that no analytical testing is recommended for this impurity (i.e., the impurity does not need to be listed on any specification).


Control of Impurities

Without compromising drug substance quality, select best control option to minimize the assessment time. A control strategy that relies on process controls in lieu of analytical testing can be appropriate if the process chemistry and process parameters that have an impact on the levels of mutagenic impurities are understood and the risk of an impurity residing in the final drug substance above the acceptable limit is determined to be negligible. In many cases, justification of this control approach based on scientific principles alone is sufficient. Elements of a scientific risk assessment can be used to justify an option 4 approach. The risk assessment can be based on physicochemical properties and process factors that influence the fate and purge of an impurity, including chemical reactivity, solubility, volatility, ionizability, and any physical process steps designed to remove impurities. The result of this risk assessment might be shown as an estimated purge factor for clearance of the impurity by the process. Option 4 is especially useful for those impurities that are inherently unstable (e.g., thionyl chloride that reacts rapidly and completely with water) or for those impurities that are introduced early in the synthesis and are effectively purged. In some cases an Option 4 approach can be appropriate when the impurity is known to form, or

26 PHARMA machines & technology

is introduced late in the synthesis; however, process-specific data should then be provided to justify this approach.

Where industry can improve? Sub type of potential genotoxic impurity (PGI) related deficiencies and recommendations: PGI not addressed Provide a complete list of PGIs from reagents/starting materials/in-situ or isolated intermediates/by-product through simple comparison with a known alerting functionality, and through searches of published information such as CCRIS. Control not sufficient For Option 3, Acceptance criterion above the TTC, demonstrate process capability at the pro-

posed level with spike/purge data. Ames (Q) SAR data not sufficient Quality data of AMES test, which can be performed per ICH S2(R1) and OECD 471 Bacterial Reverse Mutation test (Ames test). Quality data of (Q)SAR, from ICH M7 compliant software. TTC not acceptable Calculate with MDD and Acceptable intakes per RLD information. M7 exemption not Acceptable M7 Exemption applies to drug substance and drug product intended for advanced cancer indications; or, drug substance itself Genotoxic at therapeutic concentrations.

Control ~ Scientific Knowledge ~ Compliance Control of PGI's is one of the main reason for major deficiencies in DMF's. Following ICH M7 step by step could make control of PGI's right first time.

In depth understanding of the formation, fate and purge will facilitate selection of appropriate control strategy. This will reduce the assessment time and increase the chance that the DMF will become adequate with in ANDA first cycle review clock.

Compliance with ICH M7 is required in post approval submission. See ICH M7 Appendix-1 for applicable scope scenarios.

Feb - March 2020


Control of Impurities

NDMA/NDME Regulatory Perspective & Lesson Learned CASE STUDY Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure. Background In July 2018, EMA & FDA cited a major issue related to genotoxic impurity, NDMA (N-nitrosodimethylamine), and subsequently NDEA (N-nitrosodiethylamine) An API used to manufacture generic angiotens in receptor blockers (ARBs) was supplied by two Chinese companies, Zhejiang Huahai and Zhejiang Tianyu. It was later discovered in API manufactured by Indian manufacturer Hetero Labs. Both NDMA and NDEA are considered genotoxic compounds as they contain a nitroso group, which is a gene mutating group. Most ARBs have a chemical structure that includes a 'Tetrazole' group. These impurities also have potential to roll over to other 'Zoles' such as Omeprazole.

Regulatory perspective of post approval changes As per EDQM guideline (revised 2014) for revisions to an ap-

What's gone wrong in Valsartan? proved certificate of suitability (CEP,) major change is seen as changes in manufacturing process/addition of an alternative manufacturing process for a starting material, intermediate or final substance likely to change the qualitative and/or quantitative impurity profile. (e.g., new reagents, solvents, materials are introduced in the synthesis). The alternation of solvent was a major change, however the manufacturer missed reporting the generation of the new impurity (NDMA/NDEA). EDQM subsequently (September 2018, with implementation date of January 2019) changed the above revision guideline to include evaluation for genotoxic impurities as well. Apart from valid CEPs, a few India companies withdrew their filings while four were suspended by EDQM. USFDA guideline 'The guidance Changes to an Approved NDA or ANDA' is clear to alert manufacturers to evaluate and assess the new impurities that may form during the changes.

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New draft guidance Postapproval Changes to Drug Substances Section VIII.B (Changes in Route of Synthesis of One or More Steps) clearly states explicitly about impact assessment as per ICH M7 for genotoxic impurities. Nitroso impurities are very well studied and documented in food industry and drinking water specifications worldwide. However, their origin and impact were not studied or extrapolated in pharmaceutical substance manufacturing processes.

Lesson Learned To avoid cases similar to this in the future, the pharmaceutical industry may have to consider adopting a collaborative approach during the research, development, and manufacture of drug substances to absorb the knowledge available in other domains.


Control of Impurities

ELEMENTAL IMPURITIES The presence of elemental impurities in drug products can potentially have adverse health effects. Limits have been established for permissible amounts of elemental impurities in drug products. Elemental impurities may include catalysts and environmental contaminants. Elemental impurities may arise from natural occurrence in raw materials introduced inadvertently (for example from manufacturing equipment).

Element Toxic Effects Cd: Lung Cancer/ Stomach Irritation/Prostate Pb: Brain/ Kidney damage/Central Nervous system As: Skin Damage/Carcinogenic /

Chromosomes Hg: Nervous Centre - Brain /Kidney/Fetuses

Existing Elemental Impurities Test: USP <231> USP <231> is a test for "heavy metals". Test indicates the total content of metal impurities using a colored sulfide precipitate. It is in use since 1905. It is not element specific, but a visual (subjective) comparison test. Standard solution color can change over time resulting in poor reproducibility. There are also issues with poor recovery when ash sample prep procedure is used.

Guidelines available on Inorganic Impurities and its estimation

EMA ICH Q3D Guidelines (EMA/CHMP/ICH/353369/201 3) −Effective from: 01/06/2016 (for new marketing authorisation applications) 01/12/2017 (for authorised medicinal products). USP General Chapters: USP Establishes January 1, 2018 as Implementation Date for Elemental Impurities. −<232> Elemental Impurities—Limits in Drug Products −<2232> Elemental Contaminants in Dietary Supplements −Removal of <231> Heavy Metals

Classification of Elemental impurities Class

Toxicity & likelihood of Occurrence


Class 1

Human toxicants, minimum or no use in the manufacture

Arsenic (As), Cadmium (Cd), Mercury (Hg) and Lead (Pb)

Class 2 A

Human toxicants (route specific) , high probability of occurrence

Cobalt (Co), Nickel (Ni), Vanadium (V)

Class 2 B

Human toxicants (route specific) , Low probability of occurrence

Silver (Ag), Gold (Au), Iridium (Ir), Osmium (Os), Palladium (Pd), Platinum (Pt), Rhodium (Rh), Ruthenium (Ru), Selenium (Se), and Thallium (Tl)

Class 3

Low toxicities (oral route)

Barium (Ba), Chromium (Cr), Copper (Cu), Lithium (Li), Molybdenum (Mo), ANTIMONY (Sb) and Tin (Sn)

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Feb - March 2020


Control of Impurities

Potential sources of elemental impurities

Examples of potential outputs of the risk assessment

Elemental impurities that are unintentionally added and are potentially present in the drug substance, water or excipients used in the preparation of the drug product. Elemental impurities that are potentially introduced into the drug substance and / or drug product from manufacturing equipment.

Elemental impurities excluded from the risk assessment (see Q3D: Table 5.1)

Risk assessment approaches Here are examples of general approaches that may be considered during elemental impurities risk assessment. These approaches or others may change as information becomes available or additional experience is gained. Assessment of potential elemental impurities in the drug product: Determine or assess the levels of elemental impurities in the final drug product. Depending on the formulation type, an evaluation from the container closure system may also be required. Assessment of potential elemental impurities from each component of the drug product (API, excipients, container closure system): Assess each component for potential sources of elemental impurities; identify known or likely elemental impurities; and determine the contribution of each component or source of elemental impurity to the levels in the final drug product.

32 PHARMA machines & technology

Elemental impurities that may exceed the control threshold but are below the PDE in the drug product

Elemental impurities in this category would be those that have Class 2B elements that are not inthe potential to be found in the tentionally added. Elements in drug product or in drug product Table 5.1 that may be excluded components. based on the route of adminisExample: Pb is a potential imputration. rity in K2CO3. If the formulation Example: For a solid oral drug contained 500 mg K2CO3 in a product, the following class 3 ele1 g tablet and the observed Pb mental impurities were not intenlevel in K2CO3 was 1-8 µg/g, tionally added and therefore the total amount of Pb contribuwere not considered in the risk tion to the drug product would assessment: Li, Sb, Ba, Mo, Cu, be 0.5-4 ppm. The range of obSn, and Cr. served levels is above the control threshold but below the PDE (5 Elemental impurities that µg/g). may be present below the control threshold in the drug Elemental impurities that product may exceed the PDE in the Elemental impurities in this category would be those that have the potential to be found, but if present would be found at low levels. They are often associated as low level impurities in components that can be handled through incoming material controls or with GMP Quality System elements (e.g. vendor/supplier qualification processes and procedures). Example: Pb is a potential impurity in TiO2. If the formulation contained 10 mg TiO2 in a 1 g tablet (1% TiO2) and the observed Pb level in TiO2 was 1-10 µg/g; the total amount of Pb contribution to the drug product would be (0.010.1 µg/day), less than the control threshold of Pb (1.5 µg/g) in the drug product. Feb - March 2020

drug product Elemental impurities in this category would be those that exceed the PDE in the drug product. Example: Cd is a potential impurity in CaHPO4. If the formulation contained 500 mg CaHPO4 in a 750 mg tablet and the observed Cd level in Ca2HPO4 was 8-9 µg/g, the total amount of Cd contribution to the drug product (5.3 - 6 µg) would exceed the PDE for Cd 5 (µg/day). Comparison of Observed Levels with PDE The elemental impurity level is <30% of the PDE. If this is the case, then no additional controls are deemed necessary. The elemental impurity level in the drug product is greater than


the control threshold but does not exceed the PDE; additional measures may be implemented to insure that the level does not exceed the PDE. If the elemental impurity level exceeds the PDE , additional measures should be considered to ensure the levels do not exceed the PDE.

Control of Impurities

product sections of the application, sections S4.2 and 3, P5.2 and 3. Excipient contributions may be included in their controls or referenced to a Drug Master File (MF) of the supplier, Type IV. GMP expectations for EI

EI test data documentation rational for setting specifications in When additional measures are eithe drug substance and drug ther not feasible or unsuccessful, product. levels of elemental impurities Testing Laboratories are subject higher than the established PDE to GMPs. Full validation of anamay be justified in certain cirlytical methods at the site and in cumstances. the application is needed. The safety impact of the elemenJustification for EI higher tal impurity level should be evalthan established PDE uated as described in Q3D. It should be noted that if an acIntermittent dosing; short term ceptable level (AL) is the level dosing (i.e.,30 days or less); and forming the basis of the compar- specific indications (e.g., life ison, the final acceptance of the threatening, unmet medical proposed limit is dependent on needs, rare diseases). approval by the appropriate regProposed level higher than an esulatory authority. Module 1 contablished PDE should be justified tains additional information on case-by-case. the establishment of ALs.

Documentation and control strategy Filing expectations for new drugs Risk assessment for elemental impurities – (Summation option). Contribution of components of the drug product to be included in the "Pharmaceutical Development Report", section P2.3 of the application. Specifications for elemental impurities to be set according to ICH Q3D limits. Testing methods and validation for controlled EI to be included in the drug substance and drug

34 PHARMA machines & technology

This is also confirmed on three production scale batches where Pt were found in 24%, 19% and 22% of an amount corresponding to a PDE calculated by Option 2b. For these three batches the levels of Pt is below 30% of the PDE. However, impurities introduced late in the synthesis constitutes a higher risk of being carried through and the control threshold could be exceeded. A specification for the drug substance was set that ensures compliance of the drug product with the PDE. The applicant proposed to apply Periodic Testing after confirmation on 10 batches.

Industry Challenges The most significant challenges for the industry is the practical implementation of ICH Q3D guideline.

Elemental impurity assessment presents new challenges which include: determining how to assess or quantify the risks associated with factors such as water, conCan periodic testing be aptainer-closure systems and explied to elemental impuricipients; and defining where in ties? the assessment process data may Caste Study: An applicant has be required and identifying developed a new tablet form where risks can be determined to medicine. The active substance be negligible through a thoris manufactured by a route ough scientific theoretical risk aswhere the last step is a catalytic sessment also present significant hydrogenation with platinum on questions. carbon as catalyst. Development and validation of After filtration to remove the cata- analytical method used to deterlyst, the substance is isolated by mine elemental impurities; time crystallization. consuming analytical method and increase in analysis cost; In the risk assessment the appliand requirement of costly and socant concludes that the filtration phisticated instrument are the and the crystallization are likely other challenges. to reduce the levels of Pt. Feb - March 2020


Agile Environment

Creating an Agile Environment

to Support Sustainable Growth The panel discussion at Eminence Business Media's 3rd Annual Pharma Project & Portfolio Management Summit 2020 deliberated on “Creating an Agile Environment to Support Sustainable Growth”. Here's what the experts had to say...

'Desperately looking forward to agile framework' ile frame work should be understood by the project portfolio and CXO people in right perspective. It will not establish overnight. Moreover, it requires systematic planning by top management. The initiative should be initiated from the CEO desk with proper detailed execution plan. The critical work will not be reduced but losses, rework, delay, Mr. Milind Wakaskar lag time, time consumAgile Coach & Sr. Program Manager ing processes will be reduced to considerable L&T Infotech Ltd extend. This is the The pharma industry is value addition agile is bring to desperately looking forthe table. ward to agile framework The tasks alignment as per the anticipating the desired change on these areas. However, the ag- market demands/fluctuations

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Feb - March 2020

and concerns/challenges with respect to the safety of the molecule can be better addressed by agile way of working rather than waterfall methodology. People interaction and knowledge is the backbone of agile framework. It is more people oriented than process, but keeps the process authenticity intact. Critical process we must follow that is the customisation we need to configure when it comes to pharma agile project management. Less documentation does mean exclusive sprint have their place where team will document the artefacts which was not planned in previous sprints due to exigency or adhere to agile framework. Such customization is the responsibility of agile leaders and SMEs of the respective functions.


Agile Environment

Roadmap to induce agility to pharma industry Agile Transformation Plan: Pharma companies need a systematic agility culture percolating from the desk of CEO, COO, CFO, CIO to across the organisation to all individuals. The industry is very rigid and has tremendous misconception and phobia for Agile Way of Woking (AWOW). Need of visionary agile leaders to set up and nourish agile environment at org level across the organisation till the last person in the hierarchy. Person with visionary mindset is needed not just an agile project manager. There are thousands of agile project manager we have in IT but very few has visionary eye site. Very few has enterprise level experience of implementing agile at org level. Moreover, the pharma industry needs agile leader who can understand their business and has experience of implementing enterprise level project in agile way. Preferably a pharma graduate who knows the pharma operations like R&D, regulatory affairs and manufacturing with enterprise level agile project implementation experience from IT is the right person. Transparency, sharing and discouraging information silos. Collaborative approach than solitary. Induce empathy traits among the employee for problem solving. Design systematic customised organisation specific agile framework and integrate to function specific agile plan like R&D, regulatory, operations, sales & marketing, finance & procurement etc. Encourage brain storming interactive discussion with respect to issues, concerns, process within the teams, inter-department and outside systems like drug approval authorities etc. on daily basis or as appropriate. Delegating powers to the team to take decision and creating sense of ownership and accountability for the work items in their bucket. Inducing right attitude for Accepting “New Way Of Working” (NWOW), “New Way Of Thinking” (NWOT) culture. Revisit the processes for process improvisation and discover trade off for optimal goal objectives. Comprehensive training plan on agile methodology to render training, workshops to facilitate the agile culture on regular basis. Appoint inhouse CXO level panel to create a war room for addressing the concern and issues pertain to filing, registering the molecules to fast track or to achieve optimal TAT in response by FDA and respective country specific drug approval authority. Automation and cutting age technology like AI and ML have bigger role to play for the success of agile framework. The AI and bots will replace monotonous repetitive work with minimum human intervention and decision making will be easier and more automated.

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AWOW Agile Way Of Woking

One thing is clear and obvious that pharma industry must think seriously on AWOW and there is no way out. It is now or never. The cost and time benefits must be perceived in right perspective by implementing agile. Novartis perceived the benefits and are the early mover on implementing agile framework. The trend will be shortly picked up by couple of more companies soon however majority are still spectator standing on the river bank and hesitate to jump in the main stream. Rigid mindset pulling the people back and are reluctant for new change however day is near that people willing or by force to accept the change.

Hope the discussion was an eye opener who attended the Summit and I feel such more events we need to facilitate the acceptance of AWOW among the pharma world. - Mr. Milind Wakaskar Agile Coach & Sr. Program Manager, L&T Infotech Ltd


Agile Environment

'Emerging markets will become increasingly important'


It's a very old story in the Indian pharma that the generics industry is being driven by the regulated markets. We as organisations tried to sell our products to the regulated markets of US and Europe. But in today's scenario wherein cost erosion, competition, different US laws, etc. are making us difficult to introduce new products, or the already commercialised products are making less margin. In this scenario, the profits are not being as it used to be.


Each organisation strives for the market or the products which are lucrative. There are a number of molecules which are still lucrative in the regulated markets, but they are highly complex, and are high barrier molecules. In general terms, there are a number of molecules which have lost their credibility in the US market. This situation has created a new opportunity for the pharma industry in emerging markets like Brazil, China, Russia, Mexico, etc. How these markets can help organisations to build sustainable growth, and how the agile technology in place of waterfall will help introduction of all these products which are already there in the regulated markets or the new developments in the emerging markets are what we should be discussing. - Dr. Mahendra Shiradkar Lead: FDS Project and Portfolio Management, Mylan

'One day you will have to accept agile, willingly or by force'


Agile is based on people's interaction, the technology they utilize, their focus, and the turnaround time. It's about fast-tracking project management. Here the people are more interactive, and they are not sitting on information silos. They are vocal if they are facing any problem. Brainstorming is another factor of agile project management. Agile is more goal-oriented, that you are going to achieve this goal. If you want to modify the process, notify the stakeholders that you are going to modify this process because you are facing this problem, and escalate it with people who are the main stakeholders. - Mr. Milind Wakaskar, Agile Coach & Sr. Program Manager, L&T Infotech Ltd

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Agile Environment

'We do discuss with people, we do interact with people'

I frankly disagree when anybody says that we are not agile. We do have waterfall concept, but at the same time one cannot say that we are not agile. We do discuss with people, and we do interact with people. The thing is that we set small, small targets, and when that small milestone is achieved we come together and discuss what went wrong and what went right. How do we go about it when we are behind the plan, and what's the business impact? On one fine day we don't say that this project is going wrong, and that we have lost money. We don't do that. It's the same with API as well as formulation.

Many of us are working on both the regulated and non-regulated markets. The major reason for going to non-regulated market is cost, it's the business decision. We need to be very costcompetitive in non-regulated markets. We need to be very agile in our approach when we are shifting from the US market to a non-regulated market. We need to consider the IP scenario, and our efforts need to be more diversified.

Ms. Princy Achankunju, General Manager & Head - Project Management, Lupin

It won't happen one night that all projects would go agile. You have to train people, and you should have the agile transformation plan in place on how you are going to introduce agility. It should percolate from the top management to down the line. The top management, the leaders are responsible for making an agile transformation plan, and then you can go step by step down the line.

The pharma people who are only on waterfall will have to willingly or by force accept agile one day. For that you have to do the necessary groundwork and homework. You have to focus on your strength on whether you organisation can accepts agility. All the HoDs, research and development, QC, operations, marketing, IT, and all should be taken into confidence. Are we prepared for agile? Are we going to go for agility, and then how? It's the agile transformation plan that makes it happen, that how you are going to percolate agility, the agile culture down the line. - Mr. Milind Wakaskar, Agile Coach & Sr. Program Manager, L&T Infotech Ltd

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It's very clear that there are lots of changes taking place world over. The amount of change that is taking place today is just so enormous that project management is not going to be the same again. I always consider the project manager to be the CEO of his project. If he is unable to understand what's happening in the world right now, he will be unable to adapt to those changes. - Dr. Sudhir Nambiar, President – Research & Technology, Hikal Ltd

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EBM Event

Pharma Project & Portfolio Management Eminence Business Media's 3rd Annual Pharma Project & Portfolio Management Summit 2020 successfully concluded on January 23rd & 24th, 2020 at Hotel Hilton, Mumbai. The theme of the summit was “Grooming Project & Portfolio Management teams for opportunities and uncertainties�. The event had100+ delegates attending the summit with I2E Consulting, Innoventic Research & Business, and Product Dossier Solutions India Pvt. Ltd. partnering the event. The two-day event ensured the continuous engagement of the audience, speakers and exhibitors through various networking activities and discussions with regards to the ever-evolving challenges of the pharmaceutical companies related to project and portfolio management and how to overcome those challenges. The event saw as many as 17+ sessions and a panel discussion over the two days, attended by the CEO's, MD's, CXO's, Presidents, Sr. VP's, VP's, Directors, Associate Directors and Functional Heads of Project Management, Portfolio

44 PHARMA machines & technology

Panel discussion on 'Creating an Agile Environment to Support Sustainable Growth' at Pharma Project & Portfolio Management Summit 2020. Management, R&D and IP teams of the pharmaceutical and biopharmaceutical manufacturing companies. The day started with Ms. Guneet Kaur Hayer, Managing Director, Eminence Business Media welcoming all the delegates and thanking all the partners for their contribution towards the event. She also spoke about Eminence Business Media's initiative towards women empowerment via Remarkable Women Camaraderie and girl child education.

the presence of various eminent personalities from the pharma industry. The opening remarks were followed by the presentations by the chairperson and speaker Mr. John Robert, Sun Pharma; Mr. Jayesh Khatri, Enaltec Labs; Mr. Sandeep Kumar, Product Dossier Solutions India Pvt. Ltd; Dr. Srini Srinivasan, PMI India; Mr. Anand Sinha, Innoventic Research & Business; Ms. Princy Achankunju, Lupin; Dr. Gazala Khan Koticha, Novartis; Mr. PurabJajoo, Dr. Reddy's and Mr. Manish Gumber, Cipla.

The event was inaugurated with the opening remarks by Mr. Debasish Mitra, Vice President Project Management, Cipla, in

After receiving multiple feedbacks from the delegates that panel discussions are usually too formal and mostly useless,

Feb - March 2020


EBM Event

included Mr. Sudhir Nambiar, Hikal; Mr. Milind Wakaskar, L&T Infotech, and Ms. Princy Achankunju, Lupin.

Eminence Business Media created more relaxed atmosphere by using high stools instead of formal seatings. More relaxed body language during the panel discussion helped delegates open up into conversations with panel members during the session and was appreciated by everyone. The panel was moderated by Dr. Mahendra Shiradkar, Mylan, and the panel members

The event also witnessed highly interactive sessions like working tables where delegates were masters of their own sessions while Mr. Rohit Shinde, Lupin; Mr. Phanindra Akella, Syngene; Mr. Prasad Joshi, Wockhardt; and Mr. Jayesh Khatri, Enaltec Labs helped them arrive at the right solutions to the case studies issues. The day two of the event included presentations by Dr. Laila Fatima, Dr. Reddy's; Dr. Paras Vasanani, Kashiv Biosciences; Dr. Archana Badhwar, Cipla; Mr. Arunkumar Mantri, Mankind Pharma; Mr. Abhishek Mittal, GSK Consumer; and a masterclass by Mr. Umesh Kunte, Pharma & Medical Concepts Pvt. Ltd, resulting in a standing ova-

tion for him. Based on the advice that no presentations can cover the communication lag between the project and portfolio management teams, and to overcome that, Eminence Business Media organized a unique moot court session led by Dr. Bharati Nadkarni, Appropriate IP Services as the judge and jury. Dr. Laila Fatima, Dr. Reddy's; Dr. Paras Vasanani, Kashiv Biosciences were advocating project and portfolio management teams respectively while Mr. Jayesh Khatri, Enaltec Labs and Dr. Mahendra Shiradkar, Mylan, witnessing the real time responsibilities between these two highly important teams on the day two of the event. A special networking session was also arranged on day two for all the attendees where they interacted with each other and the partners also presented their solutions and services to the attendees. Eminence Business Media, maintaining the uniqueness in their event activities as always, celebrated the 71st Republic Day with all the delegates by wearing ethnic clothes as one big family together. The event was concluded with the closing remarks by Mr. John Robert, AVP Project Management, Sun Pharma followed by a group photo of all attendees.

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Feb - March 2020


EBM Event

Pharma Authors Roundtable Eminence Business Media organized “Pharma Authors Roundtable� on January 22nd, 2020 at Hotel JW Marriott, Mumbai, inviting all the young writers and authors to present their ideas, success stories, case studies on how did they manage/handle a project successfully. This event was Eminence Business Media's initiative towards creating a platform for established and new authors to get their names featured as the coauthor of an upcoming book on project management by Mr. John Robert. The roundtable was led by Ms. Guneet Kaur Hayer, MD,

Eminence Business Media. She set the expectations and rules for idea presentation and final paper submissions. The event witnessed a gathering of like-minded experts sharing their unique ideas and success stories in the presence of Mr. John Robert, AVP Project Management, Sun Pharma and

author of three very successful books on project and portfolio management. Mr. John Robert also shared his thoughts on how to be a successful author and what does it take to get your book published. He shared his ideas of his upcoming book and how to coauthor it.

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Feb - March 2020



Loading Dock



t may seem like a small issue, but each little gap you see around a parked trailer at the loading dock is costing you money each and every day. The heating and air conditioning that escapes through these gaps can cost you hundreds of dollars per year, per dock position, and that's just a start. Those gaps also allow unwanted outside elements like dust, wind, rain, bugs and rodents into your facility. This can easily contribute to product damage, cause issues with warehouse inspections and create an uncomfortable environment for your employees to work a wide variety of trailer heights in. and styles while being subjected to less damage from daily wear To combat these areas, Rite-Hite provides a series of dock shelters and tear since they aren't designed to be compressed into by and dock seals, to ensure that the trailer. They also allow for the only things going in and out full, unobstructed access to of the loading dock door are loads on the trailer for maximum things that should be. While loading and unloading effidock shelters and seals have the same goal of environmental con- ciency. trol, they are uniquely designed As a category, dock shelters histo serve different applications, so torically could not provide as knowing the differences between tight of a seal as foam dock the two will help you make the seals, but newer models are right choice for your needs. equipped with features that allow

Dock Shelters Dock Shelters are enclosures that seal the perimeter of the trailer to form a seal. This is accomplished by applying pressure against the sides of the trailer with fabric curtains fitted with fiberglass stays. They fit larger dock door openings and service

50 PHARMA machines & technology

them to match the sealing effectiveness of foam seals. For example, some older or less expensive dock shelters leave trailer door hinge gaps unsealed, amounting to about 2.5 sq ft of open space at every dock position through which energy flows out and contaminants flow in. Additionally, many shelters have less-thanFeb - March 2020

ideal sealing at the tops of trailers, and most leave large corner gaps when the trailer is backed in. Newer models, like the EclipseÂŽ shelter, however, include side curtains with a hook on the edge that wraps around the hinge gap on each side of the trailer, allowing for a complete seal. Plus trailer tops are more tightly sealed with weighted, gravitybased head curtains and corner gaps get plugged through engineered side curtain/head curtain functioning.

Dock Seals Dock Seals are foam pads that the trailer compresses into when it backs in and comes to rest against the dock bumpers, forming a seal around three sides of the trailer. Generally, dock seals provide a tight seal for a relatively


Loading Dock

be the route that makes sense.

low price, but they can become worn easily at loading docks that receive heavy traffic. Dock seals are best used when there is a minor variation in the size and style of trailers being served.

Like dock shelters, some dock seals perform better than others. Top-of-the-line dock seals are built with special features that protect against specific sources of damage, including trailer pressure and friction, burns from trailer marker lights, as well as head pad sag and pop-off.

Because of their design, foam compression dock seals can restrict forklift access to the trailer. This happens as foam and fabric from the dock seal side pads enter the trailer opening when they are compressed by the trailer. Dock seals, by design, however, typically take up less space on the outside of the dock, so if space is an issue then this may

To give you a clearer picture of how dock seals and shelters compare on a number of factors, see the chart below. Ultimately, what's important when choosing between a dock

shelter or dock seal is determining the right solution that will help you to eliminate gaps at the dock in the most efficient way possible. Both options have their advantages and disadvantages. Talk with a trained professional to analyze your loading dock to give you the individual recommendation based on your specs, needs and restrictions. Gandhi Automations provide information on the different types of Dock Shelters and Dock Seals that they offer to give you an idea of what you should be looking for.

Dock Shelters vs. Dock Seals Dock Shelters


Sealing Effectiveness


Head Curtain


Dock Seals

Generally more expensive than dock seals, and priced based on level of sealing effectiveness and durability.

Generally lower priced than dock shelters, although top dock seal models can be more pricey than low-end shelters.

Depends on the model chosen. Some provide excellent sealing effectiveness, on par with the best compression dock seals. Others leave significant gaps. Types of trailers being served can also affect sealing effectiveness. So selecting the right model is the key.

Generally very good to excellent, depending on whether top is sealed with head curtain or head pad, and whether or not seal has added sealing features.

Able to fit larger dock door openings and service a wide variety of trailer heights and styles. Less subject to damage over time.

Good for applications where dock openings are relatively small, variety of trailer sizes being serviced is limited, and/or space between door openings is tight.

Higher-end models use weight and gravity to keep in contact with the roof of the trailer and automatically position on trailer top.

Manual adjustment required

Less subject to damage from daily wear and tear

Prone to wear and tear, but these can be reduced by adding features like replaceable reinforcement boots and friction-resistant fabric.

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Feb - March 2020


CPhI & P-MEC India 2019

Over 45,000 visitors, 1,600+ exhibitors from 44 countries CPhI & P-MEC India 2019 – organised by Informa Markets – recently closed its doors to over 45,000 visitors and 1,600+ exhibitors from 44 countries, making it the largest pharmaceutical trade show in South Asia. Mirroring the event's success, India is set for rapid growth in 2020 according to the recent CPhI Annual Report Pharma Index. Cara Turner, Brand Director at Informa, said: "CPhI & P-MEC India is emblematic of the performance of the Indian pharmaceutical industry, which has made fantastic progress in the last 12 months. With remarkable results seen in the 2019 CPhI Pharma Index serving as its backdrop, this year's exhibition welcomed a record-breaking number of attendees to New Delhi. Now in its 13th year, three days of CPhI & P-MEC India staged a breadth of informative content sessions, with pharma experts from across the entire supply chain sharing their knowledge. One key trend to emerge was the continued goal of aligning India to Western regulatory standards, which experts suggest will help the country sustain significant increases in exports if harmonization of regulations continues.

54 PHARMA machines & technology

Innovation was another major talking point, with the widespread view that the current lack of innovation could potentially be one drag factor for India in the near future. Pharma experts discussed a number of proposed ideas for boosting innovation, including government investments in research initiatives and talent to form an 'Innovation Hub', as well as shifting manufacturing towards biologics development. In fact, raising regulatory standards and enhancing innovation are two crucial milestones the country must reach if the market is to achieve its 'Vision 2030' aspiration, which could result in a market valued at $130bn by the end of the next decade. There was huge interest in the latest machinery driven by the exFeb - March 2020

panding production base in India, as well as continued efforts to lower production costs and adapt equipment to the evolving drugs pipeline. In response, P-MEC India was larger than any previous year, with cutting edge manufacturers displaying the newest commercial machinery and technologies on the market. Investing in the right technologies has become an integral part of industry efforts to prepare for the next wave of growth. In its 4th consecutive year, India Pharma Week hosted a plethora of initiatives spanning over five days, giving executives the chance to engage in thoughtprovoking discussions about how to propel the country's pharmaceutical market forward. Notably, the CEO roundtable


CPhI & P-MEC India 2019

saw pharma leaders explore the benefits of Indian companies tapping into the Chinese and Russian markets. For example, the Russian government provided a number of cost-saving incentives that Indian pharma could capitalise on. This year's Women in Pharma Summit – a platform where women in the industry can give accounts of their personal experiences and success stories – proved to be a major triumph. It included a celebration of contributions made by some of pharma's brightest female stalwarts, as well as progressive approaches to better shaping a future-fit industry. The Pre-Connect Congress event brought together stakeholders from all aspects of the pharma supply chain to discuss the key drivers in Indian pharma

for the upcoming year. On top of the aforementioned 'improving regulatory compliance' and 'innovation' topics, the implications of Pharma 4.0 and Artificial Intelligence were discussed, as well as the benefits of companies diversifying their generics portfolios. Finally, the India Pharma Awards saw winners spanning 18 categories and all aspects of

the supply chain. Notable victors include Syngene, who won the 'Excellence in Contract Research & Manufacturing' award, as well as Biocon, who were bestowed the prestigious 'Company of the Year' award. Rahul Deshpande, Group Director at Informa commented, "The event never fails to educate visitors on the latest trends to emerge in Indian pharma, including new innovation initiatives and rapidly advancing harmonization efforts – it's a really buoyant time across pharma in India. Already, we are excited to return to Delhi next year, as we anticipate both Indian pharma and CPhI & P-MEC India to be hugely successful in 2020." CPhI & P-MEC India 2020 will take place at the India Expo Centre next November (25-27), with all market indicates pointing to an extremely prosperous few years ahead.

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Feb - March 2020


Mumbai Event

11th edition of pharma and lab expo


harmaTechnologyindex.com Pvt Ltd has successfully organized ten events including three at Indore, four at Ahmedabad and three events at Chandigarh. There has been substantial growth of about 25% in visiting entrepreneur and participating companies in past events. The 11th edition of PharmaTech Expo & LabTech Expo 2020 will be held from 4th to 6th March 2020 at Bombay Exhibition Centre, Mumbai. PharmaTech Expo & LabTech Expo 2020 is an international exhibition on pharma machinery, formulations, API's, nutraceutical, analytical, lab and packaging equipment. This will give opportunities to suppliers, manufacturers, industrialists, entrepreneurs, buyer and consultants to interact at this common platform.

Pharma industry in India The record of growth of the Indian pharmaceutical industry is virtually unmatched amongst other sectors of the Indian industry. Today, what is striking is that the export from this industry is more than 40 % of production in the country. The export has reached to US$ 19.13 billion during 2018-2019 and being exported to about 200 countries. The most significant aspect of the Indian pharmaceutical industry is that at the time Independence the foreign manufacturers had stranglehold on the market but today the Indian manufacturers have turned the table with the market share close to 75%. In fact India is now the fifth largest producer of drugs and pharmaceuticals after USA, Japan, Europe and China.

The industry includes about 20,000 companies at present and pharma market is expected to reach to US$ 32.2 billion by 2023. Indian companies manufacture 85% of the active pharmaceutical ingredients (API) reIndo-African Chamber of quired by the country and account for 90% of the pharmaCommerce & Industry is coceutical exports. The Indian pharcurrently organizing Reverse Buyers Seller Meet (RBSM) and in- maceutical sector has made the country self-sufficient in almost viting about 25-30 buyers, all the 300 essential drugs Ambassadors and Consulate through indigenous process techGenerals from the African counnology. The pharmaceutical intries and also will discuss about opportunities of technical collab- dustry employs close to 30 lakh people and more than two third orations, technology transfer & employed are highly qualified in investment opportunities in areas like research, quality asAfrica. The exhibition will be spread over an area of 11000 square meters and about 250 companies will display their products and expected to be visited by 8000 industry people.

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surance, pharmacy and chemistry, engineering, business and technical managers. India is the only country with largest number of US-FDA compliant plants (more than 262 including APIs) outside of USA. We have nearly 1500 WHO-GMP approved pharma plants, 253 European Directorate of Quality Medicines (EDQM) approved plants with modern state of the art technology. No other country can boast of such an infrastructure.

Pharma engineering and machinery sector About 1000 pharmaceutical equipment and machinery manufacturing units cater to the demand of the domestic pharmaceutical industry. The estimated production is about rupees 1500 crores with about 10% growth and 7% export market. Maharashtra and Gujarat are key equipment manufacturing centers in the country with Haryana, Gurgaon, Faridabad and Ambala emerging as the new production hubs. India currently exports pharmaceutical machinery and equipment to over 80 countries globally with the key export destinations such as USA, UK, Middle East, EU, etc. Thus along with the development of pharmaceutical companies, pharmaceutical machinery manufacturers are also advancing themselves to meet the challenges of pharmaceutical industries.


PharmaTech Expo

10th Edition of PharmaTech & LabTech Expo After successful deliverance of the past nine events including three at Indore, three at Ahmedabad and three at Chandigarh, the10th Edition of PharmaTech Expo & LabTech Expo was held from 20th to 22nd August 2019 at Gujarat University Convention Centre, Ahmedabad. PharmaTech Expo & LabTech Expo, organised by Pharma TechnologyIndex.com Pvt. Ltd, is a premier event dedicated to pharmaceutical innovation, technology and knowledge. Over a period, it has emerged as a crucial platform for showcasing the latest innovation and technologies throughout all phases of the product lifecycle, focusing on pharma manufacturing and processing technology, pharmaceutical systems and services. The Drug Marketing & Manufacturing Association was the Event Partner.

The focus of the 10th edition of the event, held in August 2019, was on the pharmaceutical machinery and equipment manufacturing sector and pharmaceuticals packaging, lab and analytical Instruments, along with special pavilion for pharmaceutical formulations and nutraceutical, ayurvedic, cosmetic, API’S, and chemicals and fragrance. The exhibition was planned in a space of 9000 square meters.

This year there were more than 300 exhibitors, displaying machinery and equipment for producing drugs and pharmaceutical products. More than 8000 business visitors visited the event. The exhibition area had also been increased by 20 % and there was 25% increase in number of exhibiting companies and visitor flow was increased by 20% compared to the earlier event. The inauguration function saw following dignitaries gracing the occasion: H.E. Mr. Demeke Atnafu Ambulo, Consul General Ethiopia; Dr. Bharatbhai Boghara, Chairman, Sardar Patel Sahbhagi Jal Sanchay Yojana; Dr. H. G. Koshia, Commissioner, FDCA, Gujarat; Shri P K Jha, Zonal General Manager - Central Zone, NSIC; Mrs. Sunanda Rajendran,

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PharmaTech Expo

Secretary General, IACCI; Shri Gautam Shah, Ex Mayor of Ahmedabad; Shri Jayantibhai Sanghavi, Director, Ratnamani Healthcare Pvt. Ltd; Shri Ramesh Shah, Chairman, Pharma Technologyindex.com Pvt Ltd; and Shri Amit Thakkar, President, DMMA. A large number of industry representatives, entrepreneurs, Government Officials and academicians were present during the inauguration function.

Business Seminar A Seminar on “Business & Investment Opportunity in Ethiopia Specially in Pharma & Healthcare Sector� was organised on 20th August 2019 in Association with Indo-Africa Chamber of Commerce and Industry (IACCI). In the seminar H.E. Mr. Demeke Atnafu Ambulo, Consul General Ethiopia and Mrs. Sunanda Rajendran, Secretary General, IACCI apprised the delegate

about the business and investment opportunities, export potential of various industry including pharma and healthcare sector in Ethiopia.

Reverse Buyer Seller Meet Indo-Africa Chamber of Commerce and Industry (IACCI) had organized Reverse BuyerSeller Meet concurrently with the event and brought delegates from African Countries including Cameroon, Congo, Ethiopia

and Ghana. One to one meeting with entrepreneurs / industrialist from African countries had been organised from 20th to 22nd August 2019. During the three days interaction meet between Indian exhibitors, entrepreneurs and foreign buyers, about 500 meetings were held resulting into commercial dealing.

Innovation Gallery The event partner, Drug Marketing & Manufacturing Association (DMMA) had setup Innovation Gallery wherein the members of DMMA had displayed their new innovative products.

PharmaTech Expo & LabTech Expo 2020 Mumbai: 4-6 March 2020, Bombay Exhibition Centre. Chandigarh: 17-19 April 2020, Parade Ground, Sector 17. Ahmedabad: During August 2020.

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Tech News

Technology Updates

To deliver innovative solutions and platforms Advanced container closure integrity testing Italian-based Stevanato Group, a leading producer of glass primary packaging and provider of integrated capabilities for combination products and the US-based Pfeiffer Vacuum specialized in leak testing and CCIT technologies has announced an agreement thanks to which the US Technology Excellence Center (TEC), opening in Boston in the second half of 2020, will be providing characterization testing of the containerclosure system for the biopharma industry. Leveraging the experience of SG Lab, TEC will provide analytical and testing services related to the container closure system, drug delivery devices and a set of customized services for biopharma companies' drug formulation and manufacturing process. Thanks to a highly skilled team in the area of primary container testing and a wide network of partners, TEC will guide biopharma customers in the choice of the best-suited container for their drug as well as guide them in the testing for integration in drug delivery devices as well as device selection.

Data integrity capabilities for particle counters TSI Incorporated, manufacturer of real-time viable particle counters and airborne particle counters for contamination control monitoring, has announced enhanced data integrity capabilities for all AeroTrak Portable Airborne Particle Counters, AeroTrak 9306 Handheld Airborne Particle Counter and BioTrak RealTime Viable Particle Counter. Having the capability to operate in new Data Integrity Mode, these instruments ensure complete, consistent, and accurate data according to ALCOA+ principles. Data Integrity Mode is enabled with use of TSI TrakPro Lite Secure (TPLS) Software. TPLS Software comes standard on all AeroTrak Portable, 9306 Handheld and BioTrak Particle Counters. It functions as a complete data integrity solution to centralize system management, configure instruments and generate reports. At a time when data integrity remains a focus for regulatory scrutiny, these new capabilities will ensure confident compliance for all users.

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Honeywell, a Fortune 100 technology company, has announced its collaboration with Bigfinite focused on delivering innovative solutions and platforms for the life sciences industry. The two companies will combine Honeywell's deep expertise in process automation and controls technology with Bigfinite's data analytics, artificial intelligence and machine learning platform, designed specifically for the biotechnology and pharmaceutical industries. Honeywell's life sciences-focused offerings, powered by the Bigfinite platform, will enhance manufacturing process operations and consolidate compliance-related manufacturing data contained in disparate systems across the enterprise into a single, visual interface for drug manufacturers. This will include data from laboratory information management, batch management, control, quality management, manufacturing execution and inventory systems. The goal is to enable more efficient audit-readiness and faster delivery of medical therapies to customers. Together, Bigfinite's cloud-based Softwareas-a-Service (SaaS) platform and Honeywell's advanced process automation and visualization provide real-time visibility and predictive insights through advanced analytics, artificial intelligence and Internet-of-Things (IoT) technologies with end-to-end data integrity. Through enhanced transparency, regulatory visibility and digital transformation of manual processes, the new solutions will allow life sciences companies to minimize regulatory risk, increase operational efficiencies and deliver products to customers faster while reducing rejections and waste of products.

Tech News

Technology Updates

Prefabricated cleanrooms delivered in 8 months G-CON Manufacturing, the leader in prefabricated, flexible cleanroom solutions, has announced that it has successfully delivered to Rubius Therapeutics multiple PODs with included corridors totaling 6,500 sq. ft. of cleanroom space. The PODs will provide the clean environment for Rubius' allogeneic red cell therapy clinical manufacturing facility in Smithfield, RI. The PODular facility includes areas for cell expansion, cell culture and filling areas. All PODs were built to BSL 2 requirements. The manufacturing facility boasts flexibility with the cleanroom suites being able to serve different campaigns in parallel. The facility was designed with the cleanrooms and corridor subPODs connecting them. Speed was a critical element for Rubius and achieving an 8-month turnaround (POD order to IQ/OQ) was only possible due to the dedicated and urgent work of all parties involved in the project. Prior to delivery and installation, the PODs were Factory Acceptance Tested (FAT) at G-CON's manufacturing facility in College Station, Texas, further reducing the time and complexity of installation at the Rubius site.

Celebrating 45 years of tablet deduster technology Kramer AG invented and launched the first ever vertical tablet deduster in 1975, the E79, to the world's pharmaceutical industry to address dusty tablets that caused a great deal of production problems. Kramer's invention proved highly successful in dedusting and deburring efficiency making the Kramer name synonymous with tablet dedusters. The E79 can still be found in many tablet production suites which is a testament to the efficiency, quality, design and construction of Kramer products. With this lowly beginning Kramer has become the worldwide market leader in tablet dedusting. Drawing upon 45 years of experience Kramer has continued to innovate, producing many more firsts. Kramer starts its 45th year with more product offerings than ever before, from the economical KD30 line, to its validated and tested to ISPE standards KD7070 WIP/CIP machines, and vertical capsule polishers.

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Partnership to offer better IRT experience Almac Clinical Technologies, a member of the Almac Group, has announced the launch of a standardized, operationallyproven integration between its Interactive Response Technology (IRT) platform - IXRS 3 and Exostar's Identity and Access Management Platform. The two global companies first announced a pilot partnership in December 2016 to demonstrate a proof-of-concept for eClinical application users to benefit from Exostar's industry-leading Single Sign-On (SSO) expediency and enhanced security. This latest technological advance will enable users of Almac Clinical Technologies' Interactive Response Technology (IRT) to harness Exostar's industry-leading credentialing, federation, and web-based Single Sign-On (SSO) capabilities to seamlessly and securely log in to Almac's IXRS 3 with credentials provided to each user by any member of the Exostar Life Sciences Community – which includes Trial Sponsors, Contract Research Organizations (CROs), cloud application providers, and others. Half of the world's 20 largest pharmaceutical companies and nearly 15,000 industry organizations actively participate in the Exostar Life Sciences Community. In addition, the collaboration with Exostar allows Almac to further its mission of enhancing the patient experience. The upgraded identity management capabilities within IXRSŽ 3 created as a result of the integration eliminate a major burden on trial sites, and enable them to focus more time and energy on patient care. Learn more at https://www.almacgroup. com/events/clinical-technologies/scope2020/.

Tech News

Technology Updates

Innovative compact and modular feeder design The new Coperion K-Tron line of feeders has been specifically designed to meet the growing demands of continuous processing in the pharmaceutical industry. Thanks to the use of a smaller D4 platform scale incorporating the patented and highly accurate Smart Force Transducer (SFT) weighing technology, they require significantly less floor space compared to previous models. The modular quick change design allows the easy exchange of feeder types and sizes as well as hoppers or agitators using the same scale & drive for fast adaptation to new processes and formulations while also ensuring easy cleaning and maintenance. The three available Coperion K-Tron feeder types QT20, QT35 and QS60 can be used with the same scale and drive units. The new design is ideal for multi feeder clustering in a variety of continuous processes, including direct compression (CDC), continuous extrusion, wet and dry granulation, and continuous coating, as well as traditional batch processes.

Advanced blockchain-based supply chain solution ACG Inspection has introduced an advanced blockchain-based solution that meets and exceeds traceability and anti-counterfeiting requirements in the pharmaceutical supply chain. The company's Brand Security Platform combines GS1 2D Data Matrix, smart contracts, geolocation identification and product biometrics tracking to ensure the whereabouts and contents of packaged medicines are tightly monitored through their entire supply chain journey from manufacturer to end user. The comprehensive new system provides a seamless, uncompromisingly transparent experience to all stakeholders along the supply chain, simplifying the overall process through distributed ledger technology and single ownership. It is designed to overcome several longstanding obstacles to advanced traceability, including the challenges of establishing single-owner data sets, and the prevalence of digitally broken supply chains stemming from, among other issues, struggles with GS1 universality, personnel error and new business models disrupting traditional procedures.

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To develop novel manufacturing processes Almac Group, the global contract pharmaceutical development and manufacturing organisation, has been awarded $200,000 by the Bill & Melinda Gates Foundation (BMGF) to develop novel biosynthetic routes with the aim of substantially lowering the cost of selected steroidal Active Pharmaceutical Ingredients (APIs) and enable their use in developing world aid programs. The programme of work will see the development of novel biocatalytic routes to Etonorgestrel and Levonorgestrel APIs by Almac Sciences' established team of biocatalysis experts based in Ireland. Etonorgestrel is a highly potent material currently made with mid-twentieth century chemistry which makes it very expensive at almost $200k/kg and therefore unaffordable to women in the developing world. Almac aims to reduce the cost to just $5k/kg which will make a big difference for treating patients in the developing world. Almac's proposed new route investigation builds on established methods for Norgestrel and Etonorgestrel, using a common and less expensive steroid precursor starting material. Dr Stefan Mix, Head of Biocatalysis, Almac Sciences, who developed the idea, will lead a team of three dedicated scientists through the initial proof-of-concept (PoC) stage. Upon successful completion of the PoC, the team will increase in size involving additional biologists, biocatalysis chemists and API chemist resources over the next two years. As a result of receiving this BMGF funding, the project commenced in January 2020 with the initial phase expected to last for at least three months.