FUJIFILM Irvine Scientific (FISI) is the world’s leading manufacturer of cell culture media, reagents, and medical devices that are used across the cell therapy, regenerative medicine, assisted reproductive technology, and industrial cell culture markets. The company adheres to ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan.
While Irvine Scientific was founded in 1970, Fujifilm did not acquire the company until 2018, when it invested US$800 million to become a dominant force within the cell culture media and services market.
In this interview with Yutaka Yamaguchi, President of FUJIFILM Irvine Scientific (FISI), we explore the reasons for FUJIFILM’s acquisition of Irvine Scientific, the importance of the company’s dual manufacturing facilities, traits that differentiate FISI from its competitors, and trends within the Regenerative Medicine industry at large.
Interview with Yutaka Yamaguchi, President of FUJIFILM Irvine Scientific (FISI)
Cade Hildreth: What is your background and how did you become involved with FUJIFILM Irvine Scientific?
Yutaka Yamaguchi: I am from Japan, and originally joined Fujifilm in 1990 within the film and Photography business. I have since lived Singapore, Germany, and Japan and fulfilled many roles for Fujifilm companies, including a move to the Life Science Division in 2014 as General Manager, and as President for FUJIFILM Healthcare Laboratory.
In June 2018, I joined FUJIFILM Irvine Scientific as the CEO and President when the company was acquired. I also serve as General Manager, Life Science Strategic Business office for FUJIFILM Holdings and am responsible for growing the life science businesses.
Cell culture media is central to many advanced therapies, and as such, core to the synergies between Fujifilm life science companies. My role with FUJIFILM Irvine Scientific enables me to drive initiatives for FUJIFILM Life Sciences.
Cade Hildreth: Founded in 1970, what is the start-up story of Irvine Scientific (now FUJIFILM Irvine Scientific)? How did it become a company specializing in cell culture media, reagents, and medical devices?
Yutaka Yamaguchi: Irvine Scientific was founded on May 27, 1970 as a supplier to the cell culture research community. We started as a serum supplier that processed bovine, fetal bovine, and other serum to produce the finished product; a range of classical media was quickly added to our portfolio and the company committed to becoming the leading supplier of cell culture media, seeking out experts to help innovate the cell culture industry.
In the 1980s, we entered the medical device market as the first commercial supplier of IVF media. During that decade, we also began supporting biopharma and large-scale dry powder manufacturing. As our experts saw a need to move away from serum, they developed advanced formulas to deliver high-performance growth and productivity, but without the risks associated with serum.
Cade Hildreth: What types of markets does FUJIFILM Irvine Scientific serve now (for example, Assisted Reproductive Technology, IVF, Immunotherapy, etc.)?
Yutaka Yamaguchi: FUJIFILM Irvine Scientific serves biopharmaceutical, vaccine, cell therapy, immunotherapy, cytogenetic, and reproductive medicine (Assisted Reproductive Technology and andrology) markets.
Cade Hildreth: What types of clients does FUJIFILM Irvine Scientific serve and which client segment is growing most rapidly?
Yutaka Yamaguchi: In biologics, we serve a range of clients such as large pharmaceutical, CDMO, CRO, mid-size biotech, cell banks, start-ups, and academia. Our medical device clients are large IVF clinics, donor egg banks, cytogenetic labs, OB/GYNs, and medical researchers.
The most rapid growth is seen within our biopharmaceutical client segment—pharma, CDMO, CRO, biotech, etc.
Cade Hildreth: What differentiates FUJIFILM Irvine Scientific from other companies in the cell culture space?
Industry expertise. We have 50 years of experience dedicated to understanding cell biology and the effects of cell culture media. Because we supply specialty media for both biologic therapeutic production and medical media, the breadth of cell types we support is large.
Partnership. We are a large company, but have always made customer satisfaction a priority and remain nimble and responsive. For custom media development, we collaborate closely with customers at every stage to develop personalized solutions, while also providing industry leading turnaround times.
Service. We provide unparalleled service and regulatory support. As medical device manufacturers, we have extensive experience working with regulatory bodies worldwide. This knowledge is shared with our biopharmaceutical and cell therapy customers to help them meet regulatory requirements for their therapeutics.
Cade Hildreth: When did FUJIFILM acquire Irvine Scientific and what is the significance of this acquisition?
Yutaka Yamaguchi: Fujifilm acquired Irvine Scientific June 1, 2018. Since our inception in 1934, Fujifilm has been involved in healthcare and dedicated to improving outcomes for patients worldwide through innovation. Our focus has largely been on medical imaging, but in recent years Fujifilm acquired more life science companies and is investing heavily in advanced therapies and biotherapeutics.
For the fiscal year ending March 31, 2019, Fujifilm had global revenues of $22 billion, at an exchange rate of 111 yen to the dollar.
This kind of financial strength and commitment to our industries will help FUJIFILM Irvine Scientific accelerate innovation of new products and provide the investment in our infrastructure to continue our rapid growth.
Cade Hildreth: What has changed at FUJIFILM Irvine Scientific since the acquisition?
Yutaka Yamaguchi: Fujifilm is providing significant investment to support our growth in the form of capital equipment, additional facilities, and staff to ensure we maintain the highest level of customer satisfaction.
Our new parent company also promotes open communication within and between its subsidiaries. This provides access to experts who can assist in rapid development of new technologies. The effects of these synergies will help all Fujifilm companies accelerate their growth.
Cade Hildreth: What is the importance of FUJIFILM Irvine Scientific operating dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan?
Yutaka Yamaguchi: Risk mitigation and business continuity are of paramount importance to companies providing drugs to patients. We operate multiple cGMP manufacturing facilities using the same raw materials, Quality System, and Controls to ensure uninterrupted supply to customers. This also enables us to increase production to meet demands.
The second benefit is supply chain logistics. Having product produced locally cuts down on costs and time in transit. These are the reasons we are building a third facility in The Netherlands to better support European customers and further increase our production capacity and risk mitigation.
Cade Hildreth: What trends are you seeing in the Regenerative Medicine (RM) sector and how is FUJIFILM Irvine Scientific adjusting to this evolution of the industry?
Yutaka Yamaguchi: As cell-based therapies move towards clinical trials and clearance, there is more focus on Quality by Design concepts. Since we have been supplying medical devices and raw materials for the production of approved drugs for many years, we followed a QbD approach and produce all of our media for regenerative medicine in compliance with cGMP guidelines.
Our PRIME-XV portfolio of media and reagents for stem and immune cells was developed to provide a completely serum-free workflow solution. We do think the industry is evolving to expect even more safety and demands chemically-defined (CD) media.
This is what drove us to produce the first CD medium for T cells. Subsequent CD media were developed for NK and dendritic cells. We also produce CD media for transfection and CD cryopreservation solutions, and will continue to develop new CD media for regenerative medicine.
Cade Hildreth: What are your 5-year company goals?
Yutaka Yamaguchi: Enhancing our global support to innovation and development projects to accelerate our growth and even surpass what we achieved the previous five years—while maintaining the exceptional service and quality our customers expect.
Cade Hildreth: What types of investments has FUJIFILM Irvine Scientific made to position itself as a leader in custom cGMP media manufacturing?
Fujifilm has supported us in our first year by adding two more buildings to our Corporate Headquarters in Santa Ana, CA to expand manufacturing. In July 2019, we announced the construction of a third manufacturing facility in Europe. These are large investments from Fujifilm, in addition to a substantial increase in new hires.
Cade Hildreth: How can people learn more about FUJIFILM Irvine Scientific?
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