Avirmax CMC Inc. Gotten License for cGMP Gene Treatment Vector Production by the California Department of Public Health


HAYWARD, Calif., Oct. 31, 2022/ PRNewswire/– Avirmax CMC Inc., a worldwide leader in recombinant adeno partner infection vector (rAAV) development and production procedure advancement, utilizing a recombinant baculovirus Sf9 (rBV-Sf9-AAV) system, has actually finished its new center in Hayward, CA ( San Francisco Bay Location). The center has actually gotten cGMP license approval by the California Department of Public Health (CDPH)- Food & & Drug Branch, for the production of rAAV drug items for usage in scientific examinations.

Avirmax Inc (PRNewsfoto/Avirmax)

Avirmax Inc (PRNewsfoto/Avirmax)

The brand-new cGMP center will support us to provide high yield and quality vectors effectively, prompt and expense successfully

The brand-new 20,000 sq.ft. cutting edge production center is made up of 3 practical locations– developmental labs, screening labs and cGMP production suites including B, C, and D tidy space categories, which are gotten ready for rAAV Agreement Research study, Advancement, Production Company (CDMO) service.

This center will produce rAAV utilizing single usage bioreactors (SUB) in an animal complimentary, serum complimentary suspension culture system with yields of 10 16-17 vector genome (vg) per batch with a production window of about 2 months. Production scales at 50L, 200L and 1000L, are offered to consumers depending upon their scientific trial size and dosage requirements.

The business has an around the world special license from ViroVek Inc. making it possible for cGMP production of AAV gene rehabs utilizing the Bac-to-AAV innovation, which makes use of a crafted synthetic intron including a bug promoter in both the AAV representative and cap series, paired with a flexible baculovirus expression system. The suspension bug culture system significantly improves the stability of recombinant baculoviruses, the infectivity of the AAV vectors, and AAV production yield, efficient in reaching as high as 1e +15 vg/L. The Sf9 cell culture offers greater pathogen security guarantee for gene treatment items than those made utilizing human or other mammalian cell culture systems (i.e., HEK293 or HeLa-3 cells) considering that the Sf9 cell culture barely supports mammalian infection proliferation. The Sf9 production platform can be run under a BSL-1 biological security environment, as utilized in the production of the recombinant proteins (i.e., monoclonal antibodies) by Chinese hamster ovarian (CHO), infant hamster kidney (BHK) cells.

” Our group has substantial experience and understanding in recombinant AAV innovation advancement and in rAAV production. With our brand-new center, Avirmax CMC Inc. has the ability to provide high yield and quality vectors effectively, prompt and expense successfully. Avirmax CMC Inc. is dedicated to continually innovate and establish innovations in collective relationships with our consumers and to resolve obstacles in rAAV vector procedure advancement and production,” commented Shengjiang ( Shawn) Liu, Ph.D., DVM, President & & CEO of the business. With the current CDPH approval of the cGMP center, and by using their knowledge and production experience built up in the previous years, the business can supporting customers with incorporated options, from DNA to rAAV drug item (DP), consisting of rAAV vector style, molecular cloning, expression cassette optimization, procedure advancement, production, thorough vector analysis and characterization, along with with the regulative method for gene treatment items.

About Avirmax CMC, Inc.

Avirmax CMC, Inc., a spin-off of Avirmax Inc., based in the San Francisco Bay Location, is devoted to the advancement and manufacture of rAAV vector moderated biotherapeutics utilizing its exclusive protein rehabs and Bac-to-AAV innovations.

The business was established by skilled business owner Shengjiang ( Shawn) Liu, Ph.D., DVM, who is a veteran in biologics consisting of rAAV based drug advancement. Dr. Liu was the group leader of Genentech’s Research study Virology Laboratory, co-founder and president of Abmaxis Inc. and Chief Researcher at Bayer Pharmaceuticals. The business’s co-founder, Haifeng Chen, PhD., was creator & & CEO of ViroVek Inc. Dr. Chen is a leader in the Bac-to-AAV system that was established for the massive production of rAAV vectors.

Avirmax CMC Inc. is devoted to provide its customers with excellent openness, versatility and procedure knowledge, remarkable high quality and titer AAV vectors, making capability and regulative method knowledge. To learn more, please check out at www.avirmax.com.

Please call
June Tune, Supervisor for Executive Administration
Email: business@avirmax.com
Tel: +1 -510 -641 -0201

25503 Whitesell Street
Hayward 94545 CA



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SOURCE Avirmax

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