Avirmax CMC Inc. Successfully Manufactured and Delivered to a Client the First Lot of rAAV Drug Product for a Monkey Toxicology Study
HAYWARD, Calif., Dec. 15, 2022 — Avirmax CMC Inc. (ACI), a global leader in recombinant adeno associated vector (rAAV) bioprocess development and manufacturing, using a recombinant baculovirus Sf9 cell (rBV-Sf9-AAV) system, has manufactured, tested and released its first batch of rAAV product for use in monkey toxicology and pharmacology studies for an ocular indication.
The manufacturing process was conducted in ACI’s cGMP facility, recently licensed by California Department of Public Health (CDPH)-Food & Drug Branch, for the production of rAAV drug products for use in clinical investigations. Release testing of the rAAV product were performed in-house and by selected contract research organizations (CROs) in the U.S., thus speeding up the product release process.
ACI’s rBV-Sf9-AAV platform is based on single use technology, utilizes suspension cell culture free of fetal bovine serum and uses non-animal derived material throughout the manufacturing process. The manufacturing platform contains orthogonal virus clearance technologies to ensure product virological safety. The production of >2E+15 viral genomes (vg) took less than 2 months for the company to complete, from vial thaw to cell culture, purification, fill-finish, testing and QA documentation for lot release. “The benchmark of the toxicology lot production, testing and release demonstrated that ACI’s Process Development and Manufacturing Team is reliable and capable of delivering on its promise to its customers,” expressed Dr. Shengjiang Shawn Liu, the President and CEO of the company.
In recent years, rAAV is becoming a mainstream delivery method for gene therapies. HEK293 and rBac-Sf9 cell culture systems are the two main platforms used in rAAV production. The rAAV produced by the two systems are equivalently safe and efficacious. Among the 6 approved rAAV drugs so far, three (Glybera, Roctavian and Hemgenix) were manufactured using rBV-Sf9 system and three (Luxturna®, Zolgensma® and Upstaza™) were produced using HK293 system.
ACI is dedicated to the development and manufacture of rAAV using Bac-to-AAV technologies. It offers its clients with great transparency and flexible services with solid process development expertise, skills and knowledge in rAAV manufacturing, testing and quality management. For more information, please visit www.avirmax.com.
June Song, Executive Manager of Administration
Email: [email protected]