Avirmax CMC Inc. has completed its brand-new facility in Hayward, CA (San Francisco Bay Area). The facility has received cGMP license approval by the California Department of Public Health (CDPH)-Food & Drug Branch, for the production of rAAV drug products for use in clinical investigations.
The new 20,000 sq.ft. state-of-the-art manufacturing facility is composed of three functional areas – developmental laboratories, testing laboratories and cGMP production suites consisting of B, C, and D clean room classifications, which are prepared for rAAV Contract Research, Development, Manufacturing Organization (CDMO) service.
This facility will produce rAAV using single use bioreactors (SUB) in an animal free, serum free suspension culture system with yields of 1016-17 vector genome (vg) per batch with a production window of about two months. Production scales at 50L, 200L and 1000L, are available to customers depending on their clinical trial size and dose requirements.
The company has a worldwide exclusive license from ViroVek Inc. enabling cGMP production of AAV gene therapeutics using the Bac-to-AAV technology, which utilizes an engineered artificial intron consisting of an insect promoter in both the AAV rep and cap sequences, coupled with a versatile baculovirus expression system. The suspension insect culture system dramatically enhances the stability of recombinant baculoviruses, the infectivity of the AAV vectors, and AAV production yield, capable of reaching as high as 1e+15 vg/L. The Sf9 cell culture provides higher pathogen safety assurance for gene therapy products than those manufactured using human or other mammalian cell culture systems (i.e., HEK293 or HeLa-3 cells) since the Sf9 cell culture hardly supports mammalian virus propagation. The Sf9 manufacturing platform can be operated under a BSL-1 biological safety environment, as used in the production of the recombinant proteins (i.e., monoclonal antibodies) by Chinese hamster ovarian (CHO), baby hamster kidney (BHK) cells.
"Our team has extensive experience and knowledge in recombinant AAV technology development and in rAAV manufacturing. With our new facility, Avirmax CMC Inc. is able to deliver high yield and quality vectors efficiently, timely and cost effectively. Avirmax CMC Inc. is committed to continuously innovate and develop technologies in collaborative relationships with our customers and to solve challenges in rAAV vector process development and manufacturing," commented Shengjiang (Shawn) Liu, Ph.D., DVM, President & CEO of the company. With the recent CDPH approval of the cGMP facility, and by applying their expertise and manufacturing experience accumulated in the past years, the company is capable of supporting clients with integrated solutions, from DNA to rAAV drug product (DP), including rAAV vector design, molecular cloning, expression cassette optimization, process development, manufacturing, comprehensive vector analysis and characterization, as well as with the regulatory strategy for gene therapy products.
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