FUJIFILM Diosynth Biotechnologies and RoosterBio Announce Collaboration to enable GMP Manufacturing of Cell and Exosome Therapies
College Station, Texas, October 24 2022 — FUJIFILM Diosynth Biotechnologies, a world leading contract development and manufacturing organization (CDMO) for biologics, vaccines, and advanced therapies, announced today a strategic collaboration with RoosterBio, Inc. , a leading supplier of human mesenchymal stem/stromal cells (MSCs), highly engineered media, and bioprocess development services. Through this collaboration, FUJIFILM Diosynth Biotechnologies will incorporate RoosterBio’s industry leading process development technology for both MSC and extracellular vesicle (EV) / exosome programs into its manufacturing capabilities and offerings.
This collaboration offers biopharma customers an end-to-end solution for development and production of MSC and exosome therapeutics, allowing for seamless transition of programs from RoosterBio’s process and analytical development services into FUJIFILM Diosynth Biotechnologies’ advanced therapies GMP capabilities. Manufacturing services and expertise provided by FUJIFILM Diosynth Biotechnologies will include cell expansion and collection of MSCs, downstream processing for exosome purification, and drug product manufacturing. Terms of the agreement were not disclosed.
“This collaboration will enable us to become a fully integrated cell therapy CDMO partner to our biopharma customers,” said Gerry Farrell, chief operating officer, FUJIFILM Diosynth Biotechnologies, Texas and California. “MSC products are known to have great potential in areas such as regenerative medicine and immune system modulation. In addition, exosomes are attractive as drug delivery vehicles as well as therapeutics. The partnership is aligned with our core purpose of advancing tomorrow’s medicines by enabling the advancement of our customer’s pipelines in this space.”
“FUJIFILM Diosynth Biotechnologies is a global leader in the manufacturing of advanced therapies and is creating the industry’s largest network of biologics CDMO facilities,” said Tim Kelly, chief executive officer, RoosterBio. “Biopharmaceutical companies striving to develop engineered cell and exosome therapies require proven, flexible technologies paired with reliable and scalable manufacturing capabilities. Through this collaboration, we will deliver that comprehensive solution to our customers, and I am delighted to partner with FUJIFILM Diosynth Biotechnologies to translate our MSC and exosome technologies into advanced therapy products for patients around the world.”
RoosterBio accelerates human mesenchymal stem/stromal cell (hMSC) and extracellular vesicle (EV) product and process development to fuel the rapid implementation of scalable advanced therapies. Our high-quality hMSCs, bioprocess media, genetic engineering tools, and EV production solutions are paired with expert bioprocessing knowledge to progress therapeutic developers from concept to first-in-human testing and commercial manufacturing at reduced cost and increased productivity. With optimized, scalable processes, Type 2 Drug Master Files, and cGMP products, we have enabled therapeutic programs to traverse their path to clinical translation in under 1 year. RoosterBio is driven by clients’ success and creating a world where safe and effective advanced therapies are rapidly developed and widely available on a global scale.
About FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies, a subsidiary of FUJIFILM Corporation, is a world-leading contract development and manufacturing organization (CDMO) with experience in the development and manufacture of biologics, vaccines and advanced therapies. The company operates a global network with major locations in the Unites States of America, the United Kingdom and Denmark and it is building a new manufacturing site in Holly Springs, North Carolina, USA. FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™X cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. Mitsubishi Corporation is a 20% shareholder of FUJIFILM Diosynth Biotechnologies’ UK, Research Triangle Park, North Carolina, Watertown, Massachusetts and College Station, Texas sites.
For more information, go to: www.fujifilmdiosynth.com
About FUJIFILM Holdings Corporation
FUJIFILM Holdings Corporation, Tokyo, leverages its depth of knowledge and proprietary core technologies to deliver Value from Innovation in our products and services in the business segments of healthcare, materials, business innovation, and imaging. Our relentless pursuit of innovation is focused on providing social value and enhancing the lives of people worldwide. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information about Fujifilm’s Sustainable Value Plan 2030, click here. For the year ended March 31, 2022, the company had global revenues of approximately 2.5 trillion yen (21 billion $USD at an exchange rate of 122 yen/dollar).
For more information, please visit: www.fujifilmholdings.com
Read our related press release: Fujifilm Completes Acquisition of a Dedicated Cell Therapy Manufacturing Facility from Atara Biotherapeutics, Inc.