FUJIFILM Irvine Scientific’s COO on cell therapy, COVID vaccines

Culture changes – FUJIFILM Irvine Scientific’s COO on cell therapy, COVID vaccines and 50 years of the company

From animal processing, to cell therapy and AI, Tim Mullane, president, and chief operating officer tells pharmaphorum how FUJIFILM Irvine Scientific has evolved to become one of the top manufacturers of cell culture media.

Although Irvine Scientific joined parent company Fujifilm in 2018, its roots can be traced back to the 1970s, where it started life as a bovine and animal serum processing company.

Founded by three people working in the medical diagnostic business, the Japan Energy Company (JEC) acquired a majority stake in the firm in the mid-80s.

Less than a decade later, it acquired a portion of Hana Biologicals, one of the first manufacturers of serum-free media for Chinese Hamster Ovary (CHO) formulations and what is now considered the gold standard for biologics production.

It was this acquisition that paved the way for the company’s focus on cell culture, says Tim Mullane. As chief operating officer, Mullane has supported rapid expansion of the business as it branches into new geographies and business areas including the cell therapy market.

“When I joined the company over 10 years ago it was known for its in vitro fertilisation (IVF) business. The company was also moving from being a general supplier for research applications and more into the medical and life sciences business,” he says. “We knew that based on what we had developed and acquired there was a great opportunity to serve the biopharma market.”

The company invested money to develop innovative media and modernise CHO formulas, so they were more ‘purpose-designed’, says Mullane. “We call it Rational Media Design, for specific applications. We also began servicing several small to medium-sized biotech’s that were being underserved by the larger media companies.”

According to Mullane, this strategy was the foundation for the business taking off. “We went from a very small market player to a significant one. We’re definitely in the top tier of bioprocessing media suppliers at this point, which is phenomenal growth over the last decade.”

‘Aggressive’ approach to cell therapy

The foundational businesses in embryo culture and bioprocessing also helped the company move into the emerging market of cell therapy in 2013.

“The reason we did this is because the market was already coming to us due to our expertise in embryo culture, and IVF media. These are highly regulated markets so our knowledge and experience in manufacturing high-quality products was very appealing to the cell therapy players.”

With freezing of cells and gametes taking place for decades in the IVF market, the company’s innovation proved invaluable.

“We were an innovator in moving clinics away from using slow freezing techniques – which does not offer high recovery – to vitrification, which is flash freezing and very high recovery (almost a 100% recovery). We use that to help cell therapy companies be able to freeze their cells as well.”

The company has developed a suite of media and targeted the most advanced areas of cell therapies including mesenchymal stem cells, T cells, natural killer cells, and dendritic cells.

“We’ve launched ourselves in the market in a very aggressive way,” says Mullane. “But we are passionate about cell therapy – as is our parent Fujifilm.”

However, cell therapy companies are facing challenges in trying to scale up processes in an efficient way. “It’s been a real struggle for companies and our role is to help them go through the multiple steps associated with isolating, washing, expanding, and then freezing those cells in preparation for the therapy. We work alongside not only the companies developing those therapies but also the platform technologies they’re offering from the equipment, to different portions of the process.”

FUJIFILM Irvine Scientific is also marking special milestones, last year celebrating its 50th anniversary and this year preparing to open a new European facility in Tilburg, Netherlands. The facility will reside within one of Fujifilm’s largest production centres outside of Japan. The >100,000 square foot space will be used for manufacturing of dry powder media, liquid media, and downstream bioprocessing liquids.

“Customer satisfaction is not a goal, it’s our policy,” says Mullane. “Our people really live this mission and that sometimes creates a high demand environment internally, but this is the basis on how we have grown from a small player to stand side by side with much larger organisations in just a few years.”

COVID-19 vaccine innovation

For COVID-19 vaccine development, changes in media use impacted FUJIFILM Irvine Scientific before the pandemic.

“After the last flu outbreak, the World Health Organization and groups like BARDA offered to fund preparation if there could be a move from traditional vaccine methods into cell culture vaccine approaches, so we developed a suite of chemically defined serum-free vaccine media in preparation.”

“We are a critical raw material to therapies and vaccines and because of that demand has been unmatched in our history. Thankfully, we invested in the expansion of our production capacity before the pandemic, so we have capacity to grow.”

The company supports multiple pharmaceutical programmes within Operation Warp Speed, a public-private partnership initiated by the US government to accelerate development of COVID-19 vaccines, therapeutics, and diagnostics. Along with sister companies FUJIFILM Diosynth Biotech which is producing vaccines, and FUJIFILM Toyama Chemical which developed the antiviral therapy Avigan Tablet, the Fujifilm group of companies are providing solutions for the pandemic.

As the market continues to focus on developing efficient manufacturing operations, technology will also play a bigger role. “I think we have got some major paradigm-shifting opportunities in front of us and we are looking at all the ways we can innovate. Our parent company Fujifilm has heavily invested in this area, but we also believe that the use of data through AI is going to allow us to address some very significant opportunities for efficiency improvements in the coming years.”

Tim Mullane

Tim Mullane is the president & COO of FUJIFILM Irvine Scientific, which operates in the life sciences, medical device, and diagnostics industries. Tim began as a vaccine production scientist before transitioning to commercial and operational roles. He has been a C-Officer at multiple companies for the last 20 years.

Catherine Longworth

Catherine Longworth is an editor and journalist, specialising in the healthcare sector. She was a reporter for Informa’s Pharma Intelligence division before joining pharmaphorum in 2020.

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