Biomay Launches FDA-Grade CRISPR/Cas9 Nuclease for Off-the-Shelf Purchase

Clients purchasing Biomay´s Cas9 will benefit from the company´s unparalleled track record and expertise as a market-registered GMP-manufacturer of the nuclease. Biomay is the FDA-approved manufacturer of recombinant Cas9 as the essential component of CASGEVY®, the very first CRISPR genome editing product on the market.

Biomay’s Cas9 (internal code “BMC9”) is based on the classical wild-type Cas9 nuclease from Streptococcus pyogenes. The Cas9 manufacturing process has been de novo developed, GMP-implemented and PPQ-validated by Biomay. GMP and RUO manufacturing is performed by fermentation with E. coli and by purification with chromatographic methods. By quality control with a comprehensive set of validated analytical assays, the consistent integrity, purity and potency of the product is secured.

“The addition of Cas9 to Biomay’s off-the-shelf portfolio aligns with our mission to provide high-quality and scalable solutions for emerging therapeutic modalities,” said Dr. Hans Huber, CEO of Biomay. “With this launch, we are expanding access to a critical component of gene-editing workflows, backed by our proven manufacturing expertise. Biomay´s off-the-shelf distributed Cas9, in combination with our made-to-order GMP services, will guarantee full scalability and GMP compliance throughout the whole product lifecycle.

Biomay´s latest addition further strengthens the company’s position as a key supplier in the field of gene and cell therapies. The CRISPR/Cas system, a transformative gene-editing technology, whose discovery was honored with the 2020 Nobel Prize in Chemistry, enables precise and efficient modification of genomic sequences.