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Chimeron Bio Selects Mfg. Partner FUJIFILM Diosynth Biotechnologies

To scale up drug substance manufacturing process at cGMP manufacturing facility in College Station, TX for IND-enabling work.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Chimeron Bio, an RNA company developing self-amplifying RNA (saRNA) vaccines and therapeutics, has entered into a manufacturing agreement with FUJIFILM Diosynth Biotechnologies (FDB), a CDMO with experience in the development and manufacture of recombinant biopharmaceuticals and viral gene therapies, to advance Chimeron Bio’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, TX. 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.”
 
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.

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