Recombinant protein and nucleotide manufacturer Biomay has received the green light from the FDA for its recombinant Cas9 nuclease.
The approval covers the manufacturing, testing and release of the Cas9 nuclease from its manufacturing headquarters in Vienna, Austria.
Cas9 is an essential component of CRISPR-based gene editing therapies, including Vertex Pharmaceuticals' CASGEVY.
This news follows an inspection conducted by the FDA's Center for Biologics Evaluation and Research (CBER) in December 2024, which found no observations.
This means that Biomay can now provide Cas9 to the key US market.
The recent approval is the second FDA inspection the company has passed, with the first being conducted on Biomay's downtown facility.
Biomay currently offers its clients cGMP services covering:
- Therapeutic protein production
- pDNA manufacture
- mRNA manufacture
- Process and analytical development
- Cell banking
- cGMP manufacturing of drug substances
- Aseptic filling.