FUJIFILM's New Biopharm Game Plan

There was a lot of speculation when FUJIFILM Corporation entered the biopharmaceutical business in 2011, acquiring Diosynth and MSD Biologics from Merck & Co. and partnering with Mitsubishi Pharmaceuticals, which now owns 20% of the company.  Many in the industry asked, in op-eds and on social media sites, what impact an Asian electronics company would have on the industry. 

Over the last two years, FUJIFILM Diosynth Biotechnologies U.S.A. Inc., has made a number of strategic moves:

• Developing and manufacturing antibody drug conjugates (ADCs), through a strategic alliance with India’s Piramal.

• Introducing the Apollo mammalian cell platform last quarter

• Acquiring Kalon Biotherapeutics in December, and with it, modern, rapidly deployable vaccine manufacturing technology, capabilities in new cell lines, new closed cleanroom technology, and the operation of the National Center for Therapeutics Manufacturing, an advanced vaccine manufacturing facility built by Texas A&M, with funding from the U.S. Department of Health and Human Services’ (HHS’) Biomedical Advanced Research and Development Authority (BARDA). FUJIFILM currently owns 49% of Kalon, but plans to increase its stake to 100% pending achievements of key milestones.

Kalon acquisition
In three years, Kalon has gained key clients, such as GlaxoSmithKline (GSK) and MD Anderson, and grown to more than 100 employees. This is FUJIFILM Diosynth Biotechnologies’ first acquisition, but the company had been looking for ways to expand, either through new capabilities or more capacity, says John Foy, President and CEO of its new subsidiary, Texas-based FUJIFILM Diosynth Biotechnologies Texas, LLC.  “Kalon expands our capabilities into core classical vaccine manufacturing using cell-based technologies, and in viral expression, and high-containment systems.” 
Kalon’s modular technology was another attraction. As Foy notes, it has only been in use for a few years. “We want to see the facilities that exist prove that technology, which goes very well with single-use systems.” FUJIFILM Diosynth has installed 2000-L single-use cell culture equipment at both its North Carolina and its United Kingdom sites. “Today, we are capable of running processes 100% in single-use equipment,” Foy says.
 

Investment and growth
FUJIFILM Diosynth has also been investing in mammalian cell culture technology at its North Carolina and UK facilities, says Foy, who has spent the past 14.5 years in a number of different management and engineering roles in North Carolina, and who worked at Diosynth before joining FUJIFILM Diosynth. The Apollo platform is one result of this new focus. “It allows us to take a gene from a customer and put it into our platform, media and process technologies to accelerate the time from tech transfer to clinical supplies,” Foy says. 

FUJIFILM’s new Texas-based company will be focusing first on its core contract with GSK for operating a new $91-million vaccine manufacturing facility for pandemic flu response, Foy says. Texas A&M is now building the facility, which will be the foundation for Texas A&M’s Center for Innovation in Advanced Development and Manufacturing (CIADM), an R&D program that aims to prepare the nation for disease pandemics by speeding up vaccine development times.

It will use GSK’s own proprietary cell-based technology and should come online in the next 15 months, Foy says.  It will be capable of producing 50 million doses in four months.
Also underway are projects with other programs with HHS’ Biomedical Advanced Research and Development Authority (BARDA) and CIADM.  (Box)

The acquisition takes Texas’ growing biocorridor one step closer to realizing the state’s goal of becoming the nation’s third coast for biopharmaceutical manufacturing. “There’s a lot of motivation within the local community, and a very strong commitment for Texas to grow,” Foy says. “A number of interesting programs are in place to help support growth, create a critical mass of opportunities and job growth,” says Foy. “Over the coming months, we want to take 20 years of experience from FUJIFILM Diosynth and accelerate development of the Texas company into a more mature business,” Foy says.

An important part of this plan is integrating diverse manufacturing and quality cultures, as FUJIFILM Diosynth did when it combined Lean Six Sigma programs from Merck and Schering Plough with the FUJIFILM Way culture.  “We have brought these robust quality and manufacturing practices into all our facilities and will quickly bring them to Texas,” Foy says.  “What we’ll look at are operational efficiency opportunities and how to grow flexibly in a lean environment. We also bring robust overall quality systems, taking these systems to accelerate development of new systems in Texas.” 

From Years to Months: The Incredible Shrinking Vaccine Timeline

Under contract to Biomedical Advanced Research and Development Authority (BARDA) and the Defense Advanced Research Projects Agency (DARPA) bioterrorism preparedness projects, Texas A&M has been a key developer of technologies designed to reduce the timeframes required to produce vaccines. The idea is to be able to mobilize resources immediately when a pandemic strikes.Texas A&M has also played a role in developing disposable process equipment for personalized medicines, through Gradalis Construction, a company that has worked in clinical and R&D areas, and collaborated with the Mary Crowley Cancer Center.  This work has resulted in technologies that enable the kind of personalized, product-centered manufacturing and small batch sizes that biopharma will require as the industry moves to personalized medicine. 

Much of its work has focused on vaccines, and the university’s collaborations include projects that involve plant, insect, and mammalian cell culture. But its innovation and partnerships have also helped develop the manufacturing infrastructure required for fast processing. 
Under the traditional NIH timeline, as defined in 2004, it could take up to 16 years between the time that a pathogen is identified to the time when vaccines are manufactured. Plans call for shrinking that time scale down to 16 months.  

Enabling these timelines is what engineer Robert Dream, who helped design these facilities, has called the “mobile bioprocessing unit,” self-contained mobile units featuring inherent air quality and other controls.  In a talk at INTERPHEX 2013, Dream discussed these modules and how they would be employed, one per type of technology (e.g., for mammalian vs. insect or plant cells), to avoid cross-contamination. He also discussed how they would simplify scale up, as “stockpile pods” would allow a facility to increase capacity by ten fold within 24 hours. 

This technology is at the heart of the Center for National Center for Therapeutics Manufacturing, which Kalon, now FUJIFILM Diosynth Biotechnologies Texas LLC, will operate. Whether or not Texas becomes biopharma’s third US focal point, companies in its biocorridor are creating manufacturing and technology platforms that should enable shorter timeframes and better, more consistent product quality.

Article DetailsPartnership Strategies in OutsourcingSupplement to Pharmaceutical Technology
Vol. 39, (2) Supplement
Pages: s44–s45
Citation: When referring to this article, please cite it as A. Shanley, “FUJIFILM's New Biopharm Game Plan,” supplement to Pharmaceutical Technology39 (2) 2015.