Biomay, a biotech organization based in Vienna, Austria, has announced that it has successfully completed an inspection by the U.S. Food and Drug Administration (FDA). This inspection qualifies Biomay as a cGMP manufacturer and supplier of recombinant nuclease Cas9 for use in gene editing therapies.
The FDA inspection was part of an ongoing cooperation between Biomay and Vertex and CRISPR Therapeutics, which began in 2017. Biomay has been responsible for manufacturing and delivering Cas9 in support of Vertex and CRISPR Therapeutics’ clinical development of exagamglogene autotemcel (CASGEVY®), a 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.
To qualify as a cGMP manufacturer and supplier, Biomay has developed and validated a Cas9 manufacturing process, including the construction of an E. coli expression system, GMP cell banking, upstream and downstream development, and the establishment of a comprehensive set of analytical quality control methods. An in-depth product and process characterization program, analytical method validation, and full manufacturing process validation have also been completed. The recent FDA inspection was part of Vertex’s Biologics License Applications (BLAs) for exagamglogene autotemcel (CASGEVY®).
Hans Huber, PhD, Chief Executive Officer of Biomay, expressed the organization’s satisfaction with 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, Senior Vice President of Client Business at Biomay, added, “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 this goal, for the benefit of numerous patients.”
Biomay, founded in 1984, is a privately owned and fully integrated Contract Development and Manufacturing Organization (CDMO). The company’s primary focus has been the expression of recombinant proteins through the use of E. coli. Today, Biomay offers cGMP services for manufacturing therapeutic proteins, plasmid DNA (pDNA), and messenger RNA (mRNA). Its services include 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, Senior Vice President of Client Business; Tel.: +43-1-7966296-100, E-Mail: media@biomay.com / Biomay AG, Ada Lovelace-Str. 2, A-1220 Vienna, Austria
www.biomay.com
Derick is an experienced reporter having held multiple senior roles for large publishers across Europe. Specialist subjects include small business and financial emerging markets.