Vienna (OTS) – Biomay, a biotech contract development and manufacturing company based in Vienna, announces the successful completion of an FDA inspection qualifying Biomay as a cGMP manufacturer and supplier of recombinant nuclease Cas9 for use in gene editing therapies.
As part of a collaboration with Vertex and CRISPR Therapeutics that has been ongoing since 2017, Biomay has manufactured and supplied Cas9 as part of the clinical development of Exagamglogene Autotemcel (CASGEVY®), a therapy for the treatment of sickle cell disease (SCD) and transfusion-dependent beta-thalassemia (TDT). CASGEVY® is the first CRISPR/Cas9-based therapy to receive marketing approval from the FDA and MHRA and a positive CHMP opinion from the EMA.
Biomay has developed and validated a Cas9 manufacturing process for this purpose. This includes the construction of an E. coli expression system, GMP cell banks, upstream and downstream development as well as the establishment of analytical methods for quality control. A comprehensive program of product and process characterization, validation of analytical methods and the entire manufacturing process was carried out. Recently, the US Food and Drug Administration (FDA) conducted a pre-license inspection of Biomay’s facilities and systems related to Vertex’s Biologics License Applications (BLAs) for Exagamglogene Autotemcel (CASGEVY®).
Biomay’s Chief Executive Officer, Hans Huber, PhD, stated: “We are pleased that Biomay has successfully completed its FDA inspection. This inspection represents an important milestone for Biomay. It underscores our unwavering commitment to quality, continuous improvement and the highest standards Standards in all our operations.
Angela Neubauer, SVP Client Business at Biomay, added: “We are very excited about the news that the first CRISPR/Cas9-based gene editing therapy is coming to market. We are proud to support our customers in achieving this goal “To have successfully supported this, which benefits numerous patients.”
About Biomay
Biomay AG is a private and fully integrated contract development and manufacturing company (CDMO) based in Vienna, Austria. Founded in 1984, the expression of recombinant proteins using E. coli has been Biomay’s business focus from the beginning. Today, Biomay offers cGMP services for the production of therapeutic proteins, plasmid DNA (pDNA) and messenger RNA (mRNA). The company’s range of services includes process and analysis development, cell banking, cGMP production of active ingredients and aseptic filling of medicines.
Questions & Contact:
Dr. Angela Neubauer, SVP Client Business
Email: medium@biomay.com
Tel.: +43-1-7966296-100
Biomay AG, Ada Lovelace-Str. 2, A-1220 Vienna, Austria
www.biomay.com