Biomay, a biotech contract development and manufacturing organization based in Vienna, Austria, is proud to announce 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.
The FDA inspection is a significant milestone for Biomay, as it solidifies the organization’s commitment to quality and continuous improvement in all its operations. As part of an ongoing cooperation that began in 2017, Biomay has manufactured and delivered Cas9 for Vertex´and CRISPR Therapeutics’ clinical development of exagamglogene autotemcel (CASGEVY®), a groundbreaking gene edited 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, MHRA, and a positive CHMP opinion from the EMA. Biomay has played a crucial role in this achievement by developing and validating a Cas9 manufacturing process, including the construction of an E. coli expression system, GMP cell banking, and upstream and downstream development. The organization also established a comprehensive set of analytical quality control methods and performed an in-depth product and process characterization program, as well as analytical method validation and full manufacturing process validation.
Recently, the U.S. FDA conducted a Pre-License Inspection of Biomay´s facilities and systems in the context of Vertex’s Biologics License Applications (BLAs) for exagamglogene autotemcel (CASGEVY®), further solidifying Biomay’s standing as a reliable and high-quality cGMP manufacturer and supplier.
Hans Huber, PhD, Chief Executive Officer of Biomay, expressed his pleasure at the successful FDA inspection, stating, “This inspection represents a significant milestone for Biomay. It underscores our unwavering commitment to quality, continuous improvement, and the highest standards in all our operations.”
Angela Neubauer, SVP Client Business at Biomay, also shared in the excitement, saying, “We are very excited about the news of the first CRISPR/Cas9-based gene editing therapy entering the market. We are proud to have successfully supported our clients in reaching that goal for the benefit of numerous patients.”
Biomay AG is a privately owned and fully integrated Contract Development and Manufacturing Organization (CDMO) based in Vienna, Austria. The organization was founded in 1984, and since its inception, Biomay has focused on the expression of recombinant proteins using E. coli. Today, Biomay offers cGMP services for manufacturing therapeutic proteins, plasmid DNA (pDNA), and messenger RNA (mRNA). The company’s scope of services includes process and analytical development, cell banking, cGMP manufacturing of drug substance, and aseptic filling of drug product.
For further information, please contact Dr. Angela Neubauer, SVP Client Business, at +43-1-7966296-100 or email media@biomay.com. Biomay AG is located at Ada Lovelace-Str. 2, A-1220 Vienna, Austria. More information can also be found on the company’s website: www.biomay.com.
This news story has been distributed by Pressat (https://pressat.co.uk/) on behalf of Biomay AG.
