NovaCina

FACILITATING AUSTRALIAN INNOVATION IN MEDICAL MANUFACTURING

NOVACINA HEALTHCARE

THE FUTURE OF P H A R M AC E U T I C A As a prominent supplier of sterile liquid pharmaceutical contract manufacturing services, NovaCina has emerged as a leader within Australia’s pharmaceutical industry. Brett Alderson, President and Site Leader, tells us more about the company’s unparalleled capabilities and its vision for the future Writer: Lily Sawyer | Project Manager: Cameron Lawrence

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s the Australian government seeks to expand its healthcare industry, providing tax incentives of up to 43.5 percent to bolster international R&D within the country, the pharmaceutical sector is growing exponentially.

“This is a very exciting time for the Australian pharmaceutical market,” opens Brett Alderson, President and Site Leader of NovaCina, a pharmaceutical firm dedicated to producing sterile injectable medicines for over 90 worldwide markets.

Since the COVID-19 pandemic, global investment in the nation’s healthcare industry has steadily increased.

“Companies have begun to understand the geopolitically stable nature of Australia, the skill base that exists here, and the country’s proximity to major Asian markets,” Alderson continues.

Moreover, the industry has undergone a recent realisation that the manufacturing and supply of Australian pharmaceuticals cannot sustainably remain local; to achieve sufficient economies of scale and reasonable cost of goods, supply needs to extend across the globe.

“It seems that the timing is right for a company such as NovaCina to not only supply Australia, but also manufacture and ship pharmaceutical products around the globe.”

Thus, in recent years, the company has emerged as a major supplier to big, small, and speciality pharmaceutical businesses, as well as BioTechs and academic institutions, nationally and globally.

STANDING OUT FROM THE CROWD NovaCina is an ex-Pfizer site recently purchased by Bridgewest Group (Bridgewest), an organisation involved in the development of innovative life sciences, software, and deep tech start-ups, who also own another 15 companies globally.

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Brett Alderson, President and Site Leader

EARLY-STAGE DEVELOPMENT FORMULATION DEVELOPMENT: This involves either taking a pharmaceutical formula and converting it to something fit for human use or troubleshooting an existing formulation which may, for example, have solubility or stability issues. This early stage can also include the development and transfer of the analytical methods.

PROCESS DEVELOPMENT: Designing a robust manufacturing process, for example, which can take customers through to the clinical stage but always with future commercial optimisation in mind, such as scaling up.

GMP MANUFACTURING FOR CLINICAL TRIAL SUPPLY, FROM PHASE I – III: This can include products in BFS units, vials, and syringes. For example, NovaCina is launching a new SA25 aseptic robotic filling solution later this year, which will be able to flex between vials, PFS, and cartridges.

Furthermore, the company provides products for a wide range of indications.

With over 40 years of industry experience, it has operated from its headquarters in Perth since the mid1980s. Today, NovaCina boasts nine good manufacturing practice (GMP)compliant filling lines and over 400 employees.

“What started as a local company soon became international: the business rapidly expanded in the 1980s with the inception of blow fill seal (BFS) technology,” Alderson details.

BFS technology has since enabled the supply of generic sterile medicines widely throughout the Australian hospital system.

“At that time, we also added cytotoxic manufacturing, terminally sterilised vials, and other specialty manufacturing lines to our suite of capabilities, which really set us apart from the competition,” he reveals.

In addition, NovaCina has recently acquired a robotics isolator filler to be used alongside clinical trials and small batch runs of vials, pre-fill syringes (PFS), and cartridges.

Over the years, the company has obtained a plethora of achievements, awards, and qualifications.

Many of its achievements demonstrate its unparalleled competency, such as its historically low attrition rate.

In other words, NovaCina has been able to largely retain the knowledge and experience that it has developed within the company.

“We work with some complex and cutting-edge formulations, so the retention of our people is crucial for our ongoing success.”

Furthermore, the company has been audited and approved by seven regulatory bodies, including the Therapeutic Goods Administration (TGA) and the Food and Drug Administration (FDA).

“Our distinguished accreditations give customers and partners confidence that we are the right partner for them and their products,” Alderson states confidently.

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“Merck Life Science has been a terrific partner for our business of manufacturing sterile injectable medicines for over 30 years.

“They have provided what I consider to be industry-leading technical advice and support in filtration, single-use disposables, aseptic processing, and advocacy to regulators.

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- Brett Alderson, President and Site Leader, NovaCina

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“To provide a robust service to customers and patients, we also need a resilient, approved supply chain, reliable partners, and a strong financial platform, which we’re lucky to have,” he surmises.

SAFETY FIRST Due to a demand for highly manual manufacturing processes in the pharmaceutical industry in the early 2000s, workplace injuries were not uncommon.

However, having engaged leaders in site safety improvement programmes since, NovaCina now boasts an unmatched safety record.

“There is nothing more important to us than the safety of our colleagues – our deep belief in the betterment of human health opposes injuries,” 8 | APAC Outlook Issue 66

NOVACINA – AT A GLANCE • Formulation and process development.

• Clinical and commercial GMP manufacturing for BFS amps, vials, PFS, and soon to include cartridges.

• Handling of highly potent and cytotoxic compounds, often required for oncology indications and controlled substances, needed for chronic pain control and more recently for mental health indications.

Alderson outlines.

In recent years, the company has been able to design automated filling and packaging lines that remove the necessity for manual activity and dramatically reduce the injury rate.

“It is now not unusual for the site to go a whole year without recordable incidents, while maintaining a healthy reporting culture,” he continues.

NovaCina’s safety programmes have been well recognised by Pfizer, leading to the company being in receipt of a number of safety awards over the past five years.

“We are strong believers in behavioural-based safety and the engagement of safety achievements from everyone in the company,” Alderson insights.

SUPPLYING PACKAGING SOLUTIONS SINCE 1972 Located in Perth Western Australia, Percival Print & Packaging is an Australian-owned company who has served the fibre-based packaging market of Australasia for over 50 years. We have earnt our reputation as specialists in our field and are highly regarded for our craftsmanship as well as our sustainable, custom-made solutions.

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Sales Director – Anthony Pittaway

Managing Director – Colin Lamond

NOVACINA HEALTHCARE

LUMACINA In addition to the NovaCina brand, its sister company, LumaCina, specialises in the manufacturing of sterile injectable pharmaceuticals and has a portfolio of products that are actively produced at the Perth site.

LumaCina currently markets a suite of 29 individual critical care injectable medicines widely used throughout Australia today.

Furthermore, the company boasts a fully integrated R&D organisation, which works to develop additional critical products to serve not only Australia but wider global medical markets.

NovaCina is currently looking to differentiate LumaCina by increasing its development technologies and product offerings, both of which are considered key components of the company’s development pathway.

As such, LumaCina is actively licencing products for the Australian market to supply critical pharmaceutical needs and aims to expand its manufacturing capabilities to support critical dosage forms within the region.

“ T H I S I S A N I N D U S T R Y T H AT AT T R A C T S P E O P L E W H O CO N T I N U E TO I N S P I R E M E . H AV I N G T H E O P P O R T U N I T Y T O C O L L A B O R AT E W I T H S O M A N Y TA L E N T E D P E O P L E , M O T I VAT E D T O I M P R O V E T H E L I V E S O F O T H E R S , I S A P R I V I L E G E T H AT I N E V E R TA K E F O R G R A N T E D ” – B R E T T A L D E R S O N , P R E S I D E N T A N D S I T E L E A D E R , N O VA C I N A

POST-COVID PROGRESS Since the COVID-19 pandemic, NovaCina has undergone much change and alteration. Despite relative fluctuation, the company today is arguably stronger than ever.

“Lots of businesses have an interesting COVID-19 story to tell, and we are no different,” reveals Alderson.

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Within the first few months of the pandemic, NovaCina was informed by Pfizer of its decision to exit the facility.

Thus, the search for a new buyer began.

“Throughout this trying time, our amazing colleagues at the Perth site continued to manufacture and supply critical medicines to Australia and the

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rest of the world.”

In fact, the company’s supply performance improved, as it became among the highest achievers within the Pfizer sterile injectable network.

Consequently, NovaCina was able to support the provision of the vaccines pillar of the COVAX programme during the pandemic, which was introduced to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines - especially for lower and middle-income countries.

“Almost on the day that the COVID-19 travel restrictions were lifted in Western Australia (WA), new prospective buyers toured the Perth site. This ultimately led to Bridgewest’s acquisition of the

company, which was completed in April 2023,” Alderson continues.

Looking to the future, NovaCina is planning to add a new platform of technologies to make the best use of what it considers to be its core capabilities – the manufacture and worldwide supply of important sterile injectable medicines.

“This will include additional PFS and biologics capabilities,” Alderson divulges.

Moreover, the company is expanding its facilities to incorporate small-batch manufacturing, using state-of-the-art technology to develop drugs which can support specialised clinical trials and orphan drugs - pharmaceutical agents developed to treat rare medical conditions.

“This is a great addition to our capabilities in high-volume BFS and cytotoxics manufacturing,” Alderson concludes.

Tel: +61 8 9362 0666 enquiries@novacina.co

www.novacina.co

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15 Brodie-Hall Dr, Bentley WA 6102 Tel: +61 8 9362 0666 enquiries@novacina.co

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