2024. január 26., péntek 14:46 |
Biomay Announces its Successful Support of Approval of First CRISPR/Cas9-based Therapy |
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Vienna, 26 January, 2024 (APA/OTS) - Biomay, a biotech contract development and manufacturing organization based in Vienna, Austria, announces successful completion of an FDA inspection qualifying Biomay as a cGMP manufacturer and supplier of recombinant nuclease Cas9 for use in gene editing therapies. |
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As part of an ongoing cooperation initially dating back to 2017,
Biomay has manufactured and delivered Cas9 in the course 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
positive CHMP opinion from the EMA.
Biomay has developed and validated a Cas9 manufacturing process
together with the associated analytical quality control methods.
This included the construction of an E. coli expression system, GMP
cell banking, upstream and downstream development, as well as the
establishment of a comprehensive set of analytical quality control
methods. An in-depth product and process characterization program,
analytical method validation, as well as full manufacturing process
validation have been performed. Recently, the U.S. FDA completed a
Pre-License Inspection of Biomay´s facilities and systems in the
context of 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 the inspection by the
FDA. 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 added: "We are very
excited about the news of the first CRISPR/Cas9-based gene editing
therapy entering the market. We are proud of having successfully
supported our clients in reaching that goal, for the benefits of
numerous patients."
About Biomay Biomay AG is a privately owned and fully integrated Contract
Development and Manufacturing Organization (CDMO) based in Vienna,
Austria. Founded in 1984, the expression of recombinant proteins by
utilizing E. coli has been Biomay´s business focus yet from its
beginning. Today, Biomay offers cGMP services for manufacturing of
therapeutic proteins, plasmid DNA (pDNA) and messenger RNA (mRNA).
The company´s scope of services comprise process and analytical
development, cell banking, cGMP manufacturing of drug substance and
aseptic filling of drug product.
Contact: Dr. Angela Neubauer, SVP 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
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