Business Enquirer Issue 116 | Biocina | August 2023

THE BIOPHARMACEUTICAL BUSINESS TAKING THINGS DOWN UNDER BIOCINA

THE BIOPHARMACEUTICAL BUSINESS TAKING THINGS DOWN UNDER

Rivalling other prime locations worldwide, Australia has come into its own as an international front runner for biopharmaceutical research and development.

One of the major benefits for biotech companies to call Australia home is the financial incentive.

Depending on its revenue, a company may be eligible for up to a 43.5% tax credit on research and development expenditure including clinical trials, analytics and study drug manufacture. In addition, Australia’s Therapeutic Goods Administration (TGA) offers a considerably more efficient regulatory pathway through early clinical trials, than other countries. It can be expected that patient testing for a Phase 1 study may begin in as quickly as four weeks, and the entire Phase 1 trial timeline may be accelerated by as much as six to nine months.

The Australian Government’s Clinical Trials Activity initiative will provide $750 million over 10 years between 202223 and 2031-32 to increase clinical trial activity in Australia. The initiative’s focus has been expanded to enable funding of research projects focused on any disease or condition that meets the objective specified in each grant opportunity. Now, 11% of the world’s clinical trials are taking place in Australia.

One of the businesses to take this opportunity is BioCina, a Contract Development Manufacturing Organisation (CDMO) and one of 15 life science assets, collectively worth $3 billion, owned by investor, The Bridgewest Group.

Whilst the most well-known biotech hubs sit in the Northern Hemisphere, in the likes of Boston, USA, and Cambridge, UK, it is Australia that is on the path to disrupt the industry.

Sven Lee, BioCina’s Chief Commercial Officer.

Developing The Future

Based out of a facility in Adelaide, dating back to 1982 and previously owned by Pfizer, it is currently the only microbial drug substance facility of its kind in Australia to be approved by the US-FDA.

In the last 18 months since it launched, Biocina has developed its offering in three key areas of development through cGMP manufacturing: microbial platform, plasmid DNA (pDNA), and mRNA.

Within miocrobial development of various proteins, BioCina has the ability to maintain cell banks, the experience and capability for clinical manufacturing, and commercial manufacturing.

For pDNA, Biocina supplies bulk plasmid DNA in three grades: Research, Highly Documented, and GMP plasmid DNA for pre-clinical to commercial use. There continues to be growth in pDNA needs for global biotechs developing cell therapies, viral vectors and other platforms.

In April 2023, BioCina announced that it has been awarded a $5 million AUD grant under the Australian Government’s Medical Research Future Fund (MRFF) Grants scheme. This will fund work with its industry partners to develop enabling technologies for manufacture of precision mRNA vaccines.

Currently, BioCina has a GMP suite for the manufacturing of clinical and commercial microbial drug substance materials, with a bioreactor at 750L. They are looking to add an additional bioreactor up to 2000L. “Plasmid DNA can be produced up to 435L and attain yields exceeding 10g, while the RNA is currently at R&D scale of 1L with GMP expected mid-year in 2024,” explained Sven Lee, BioCina’s Chief Commercial Officer.

“We have good quality systems in place to support the products that BioCina develops and manufactures, and opportunities across platforms are growing. With the support of the Bridgewest Group, Biocina is looking to

expand its capabilities to be able to offer more to our clients in the next 12 to 18 months,” he continued.

Company Culture is Crucial

Employing 75 staff at its current facility, Sven anticipates the need to expand personnel and capacity to meet the demand of BioCina’s work in cGMP.

“We also see the potential to expand our footprint in Australia, or possibly locations such as Eastern Europe,” continued Sven.

BioCina puts a big emphasis on trust and open communication with its staff, and a goal of high employee and customer satisfaction. Ranked fourth in the world for work-life balance, this is just another reason why Australia is the perfect fit for BioCina.

During its transition from the Pfizer facility, BioCina, supported by Bridgewest, retained 90% of staff, a testament to its focus on employee happiness and satisfaction.

“We’ve recently employed a new Head of HR to encourage more staff engagement. The team is world-class, and we are very excited to have the opportunity to retain such a capable and experienced group of individuals,” said Sven.

BioCina is particularly proud of its rigorous health and safety measures, which has seen the business achieve eight years serious injury free.

Supporting Growth

After 18 months on the BioCina board, and moving within BioCina as Chief Commercial Officer at the start of 2023, this is not Sven’s first foray in business leadership.

With a degree in Biology, Sven has worked for six years as Chief Business Officer at Abzena, Senior Director of Global Business Development and Sales at Terumo BCT’s Cell Therapy Technology medical device unit, and as Global Vice

President Business Development Catalent Biologics.

During his time in these roles, Sven’s focus has been on business growth.

He has also taken on roles at Crucell (now Janssen), Sanofi and Biogen, including business development, licensing, marketing and strategic planning.

“I’m used to working cross-functionally, and I enjoy working for smaller businesses where you can truly influence growth,” shared Sven

From a leadership perspective, Sven considers it important to hire people with experience, who have the ability to “jump in and move at a quick pace”.

Leading by example, the core team at BioCina is made up of individuals with decades of clinical and commercial microbial fermentation experience.

To support BioCina’s growth, Sven believes it is imperative to form partnerships with vendors to ensure minimal disruption to clients.

“The last three years have been challenging for the industry, but there is now a lot of investment being made into CDMOs and so it's a positive time to be taking strides in the industry, and in Australia,” said Sven.

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