Expanding Fast-Growing Contract Development And Manufacturing Business For Biopharmaceuticals, FUJIFILM Launches The Bio CDMO Division

TOKYO--(BUSINESS WIRE)--FUJIFILM Corporation (President: Kenji Sukeno) is launching the Bio CDMO*² Division as of March 1, 2017 to expand its contract development and manufacturing operations for biopharmaceuticals*¹, a market segment that is expected to make strong growth.

Biopharmaceuticals are pharmaceutical products consisting of proteins and other materials produced by genetically modified microbes*³ or mammalian cells*⁴. The ratio of biopharmaceuticals in the pharmaceutical market is rising, and is expected to continue expanding, as they deliver strong efficacy despite having minimal side effects.

As Biopharmaceuticals’ manufacturing requires the advanced technologies and facilities for culturing, separation and purification of proteins, there is growing demand that pharmaceutical companies outsource process development and manufacturing of biopharmaceuticals to CDMO which have superior technologies and advanced facilities. The contract development and manufacturing market is projected to achieve growth of 8% per annum*⁵ accordingly.

Fujifilm conducts its contract development and manufacturing business for biopharmaceuticals, primarily at FUJIFILM Diosynth Biotechnologies U.S.A., Inc. and FUJIFILM Diosynth Biotechnologies UK Limited. They utilize advanced biotechnology using mammalian cells and microbes to efficiently produce proteins for use in biopharmaceuticals, and expert know-how in managing processes from culturing to separation and purification. In 2014, the company acquired Kalon Biotherapeutics, LLC (today’s FUJIFILM Diosynth Biotechnologies Texas, LLC), whose strength lies in vaccine manufacturing and high-potency low-volume manufacturing, to expand its business.

In this business field, Fujifilm has also developed the Apollo^TM technology*⁶, which increases protein production volume by five times, and achieves 20% improvement in culturing efficiency, using its technologies to manufacture under constant conditions and superior quality control, developed in the photographic film business. Furthermore, it has made significant capital investments to reinforce the company’s capabilities, thereby achieving a high level of business growth.

In this latest move, Fujifilm is separating its contract development and manufacturing operations for biopharmaceuticals from the Pharmaceutical Products Division to form the Bio CDMO Division. The company is setting up the standalone business division to further accelerate its decision-making process and enable more timely injection of management resources, with the aim of accelerating business growth. The Division will also deal with the contract development and manufacturing of small-molecule pharmaceuticals to address broader needs of pharmaceutical companies. The company is targeting to bring the Division’s revenue to 100 billion yen by FY2024/March.

Fujifilm will continue to promote its growth strategy for contract development and manufacturing of biopharmaceuticals to accelerate business expansion, while ensuring consistent supply of high-quality pharmaceuticals, thereby contributing to the further development of the pharmaceutical industry.

	*1		Pharmaceutical products manufactured through biological process, which usually functions differently from small molecule drugs. It includes various products such as vaccines, insulins, growth hormones, antibodies etc.
	*2		CDMO stands for Contract Development & Manufacturing Organization. CDMO provides clients such as pharmaceutical and biotechnology companies with a wide range of services from cell line development in the early stage of pharmaceutical development to process development, stability testing, investigational drug development / manufacturing and commercial drug manufacturing.
	*3		A group of clonal microbes capable of growing permanently while sustaining certain characteristics. Genetic modification enables microbes to grow stably for a long period of time, producing proteins.
	*4		A group of clonal cells capable of growing permanently while sustaining certain characteristics. For example a normal human cell is limited in the number of times it can divide, while some types of cells have the ability to continue growing unlimitedly, either naturally or as a result of artificial modification. Chinese hamster ovary (CHO) cell is a type widely used in manufacturing of antibodies, genetically modified to grow stably for a long period of time, producing proteins.
	*5		According to Fujifilm data
	*6		ApolloTM is a high-performance cell expression technology that delivers manufacturing-ready mammalian cell lines, suitable for volume production of biopharmaceuticals, in a period about 30% shorter than the company’s previous timeframe. The developed mammalian cell line achieves approx. five-fold increase in protein production per liter of culture tank compared to Fujifilm’s previous technology.