Biomay Offers AAV Starting Plasmids in GMP and Research Quality – Off-the Shelf
Biomay today announced the expansion of its cutting-edge offerings in gene therapy: the company now offers ready-made starting plasmids for the manufacture of recombinant adeno-associated virus (rAAV) vectors.
The offered DNA plasmids are immediately available in the quality grades “RUO” (research use only) and “GMP” (clinical / Good Manufacturing Practice). The new catalog products are available off-the-shelf and distributed via Biomay‘s webshop.
In a first round, Biomay has launched the following AAV plasmids in GMP and RUO quality grades, for off-the shelf distribution:
- Adenovirus (Av) helper plasmid (size-optimized)
- AAV2 starting plasmid (Rep serotype 2/Cap serotype 2)
- AAV5 starting plasmid (Rep2/Cap5)
- AAV6 starting plasmid (Rep2/Cap6)
- AAV8 starting plasmid (Rep2/Cap8)
- AAV9 starting plasmid (Rep2/Cap9)
By early 2025, the company will make additional AAV plasmids available, such as an eGFP reporter plasmid and transgene backbone vectors, and further Rep/Cap plasmids such as the capsid serotypes 1 and rh10.
Biomay’s clients will benefit from:
- Off-the-shelf availability: No more waiting for custom production. Biomay‘s GMP and RUO plasmids are available at various aliquot sizes for immediate purchase, accelerating clients’ project timelines.
- Excellent plasmid quality: Each plasmid undergoes rigorous quality control testing to ensure purity, stability, performance and batch-to-batch consistency.
- Seamless regulatory compliance: Biomay‘s GMP certification guarantees all plasmids meeting stringent regulatory requirements, paving the way for smooth clinical development. Each GMP batch is Qualified Person released.
As Dr. Angela Neubauer, Biomay’s SVP Client Business, points out: “During the past years, we have witnessed the enormous progress in AAV clinical research, resulting in an impressive and steadily growing list of AAV gene therapy products on the market. Biomay has meanwhile a strong track record of around fifteen years in GMP manufacturing of AAV plasmids. We are proud that now we can offer fully GMP-manufactured AAV plasmids to our customers as catalog products via our webshop. This offering will perfectly complement Biomay‘s custom services for DNA plasmids. Our clients will benefit from the broad range of different AAV capsid serotypes that are widely recognized for their gene delivery efficiency across different tissues. In future, Biomay will extend its GMP off-the-shelf portfolio further to offer products like lentiviral starting plasmids or recombinant nuclease Cas9.”
About Biomay
Biomay AG is a fully integrated Contract Development and Manufacturing Organization (CDMO) based in Vienna, Austria. Founded in 1984, the expression of recombinant proteins in E. coli has been Biomay‘s business focus yet from its beginning. Today, Biomay offers cGMP services for manufacturing of messenger RNA (mRNA), circular plasmid DNA, linear IVT-template DNA and therapeutic recombinant proteins. Biomay operates a dedicated mRNA Competence Center for cGMP manufacturing and QC testing of mRNA drug substance and drug product (clinical, commercial). The company‘s scope of services comprises process and analytical development, cell banking, R&D material supply, cGMP manufacturing and aseptic filling. Biomay‘s facilities are inspected by the US FDA.
Contact
Dr. Angela Neubauer, Senior Vice President Client Business; request@biomay.com
Biomay AG
Ada Lovelace-Str. 2
A-1220 Vienna, Austria
www.biomay.com