Regulatory and Quality

uBriGene's one-stop gene therapy CDMO service platform has rigorous and professional QA and QC teams to meet the testing requirements of many projects of GMP AAV and Lentivirus.

 

Please Contact Us to request for details of Quality Category, Quality Method, and Quality Standard for specific CDMO services like GMP Plasmid, GMP AAV, GMP Lentivirus, Cell Banking, CAR Cell Therapy Manufacturing,  GMP iPSC Production. 

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uBriGene has completed the methodological development and verification of more than ten GMP plasmid products. Our proficient and experienced Regulatory Affair teams in North America and China are providing relevant data for client's IND application or applying IND to FDA on behalf of our clients.