Philadelphia, Penn. and College Station, Tex. – Chimeron Bio, an RNA company developing self-amplifying RNA (saRNA) vaccines and therapeutics designed on its proprietary ChaESAR™ RNA delivery platform, today announced it has entered into a manufacturing agreement with FUJIFILM Diosynth Biotechnologies (FDB), a leading Contract Development and Manufacturing Organization (CDMO) with experience in the development and manufacture of recombinant biopharmaceuticals and viral gene therapies, to advance the Company’s Oncology portfolio to the clinic.
Chimeron Bio selected FUJIFILM Diosynth Biotechnologies as its partner for the transfer and scale up of their drug substance manufacturing process. Drug substance manufacturing will be carried out in FUJIFILM Diosynth Biotechnologies’ state-of-the-art cGMP manufacturing facility in College Station, Texas. Materials from this partnership will help facilitate Chimeron’s IND-enabling work and entry into the clinic.
“We selected FUJIFILM Diosynth Biotechnologies as our manufacturing partner because of their proven track record in the advanced therapies space,” said Jolly Mazumdar, chief executive officer, Chimeron Bio. “FDB really understands our ChaESAR™ platform and pipeline potential, making them the best partner to scale up our processes and help bring our ground-breaking approach for the treatment of underserved patients closer to reality.”
“Chimeron’s ChaESAR™ platform has the potential to impact how we bring treatments and therapies to patients,” said Gerry Farrell, chief operating officer, FUJIFILM Diosynth Biotechnologies, Texas site. “We are delighted to be the partner of choice to bring their technology into our GMP facility and produce Bulk Drug Substance to support their clinical trials.”
About Chimeron’s ChaESAR™ platform
The ChaESAR™ platform is a self-assembling biosynthetic non-lipid nanoparticle (NLNP) comprising a self-amplifying RNA genome encased within a capsid with a surface ligand of choice.
About Chimeron Bio
Chimeron Bio is a biotechnology company focused on the development of self-amplifying RNA (saRNA) therapeutics and vaccines across therapeutic areas. The company is using its proprietary ChaESAR™ platform to develop a pipeline of products in oncology, rare genetic disorders, and infectious diseases. It is based in Philadelphia, Pennsylvania, USA. For more information, visit https://www.chimeron.com.
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. FUJIFILM Diosynth Biotechnologies has existing locations in Teesside, UK, Research Triangle Park, North Carolina, USA, College Station, Texas, USA, Watertown, Massachusetts, USA, Thousand Oaks, California, USA and Hillerød, Denmark, the company is currently building manufacturing facilities in Watertown, Massachusetts, USA, and 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: https://www.fujifilmdiosynth.com