uBriGene operates five advanced GMP manufacturing sites worldwide—four in APAC and one in the U.S.—with 50 GMP production lines for plasmids, viral vectors, cell therapies, and RNA-LNP. Our facilities adhere to the Quality by Design (QbD) concept and meet all current cell and gene therapy regulations.
With state-of-the-art global manufacturing facilities, uBriGene offers comprehensive production solutions for every stage of development.
Our streamlined production platform, robust GMP system, and extensive project experience enable us to meet clients' manufacturing needs across all phases, including early research, IIT, IND, clinical trials, and commercial production.
Five (5) global GMP commissioned sites with DMFs with the FDA
Grade C+A / B+A cleanroom standards with independent HVAC systems for each suite
Governed by the US FDA GMP guideline, NMPA GMP, ICH, and EU GMP for the GMP manufacturing
Total of 6 plasmid, 9 viral vectors, and 22 cell production lines (including cell banks).
As a cell and gene therapy CDMO, uBriGene upholds the highest quality standards and regulatory compliance. We ensure rigorous quality control, adherence to FDA, EMA, and CDE guidelines, robust documentation for full traceability, and continuous improvements based on audits and advancements, supporting safety, efficacy, and regulatory approval.
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Extensive GMP Manufacturing Track Record
Streamlined, platform-based processes
20+ INDs filed and cleared with the FDA, EMA, and CDE
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Utilizing the FDA's applicable Code of Federal Regulations and ICH Q10, uBriGene ensures quality through various controls, including continuous improvement via process and product quality monitoring, a robust auditing program, and a stringent product control program.
Additionally, our quality assurance measures include quality event reporting, material management with an approved vendor list, and an equipment policy program. Our comprehensive quality control program ensures that every aspect of our operations meet’s stringent regulatory requirement.
Request a quoteUtilizing the FDA's applicable Code of Federal Regulations and ICH Q10, uBriGene ensures quality through various controls, including continuous improvement via process and product quality monitoring, a robust auditing program, and a stringent product control program.
Additionally, our quality assurance measures include quality event reporting, material management with an approved vendor list, and an equipment policy program. Our comprehensive quality control program ensures that every aspect of our operations meet’s stringent regulatory requirements.
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Request a quoteLearn how uBriGene can be your bridge from ATMPs concepts to commercialization.
Learn about CAR-T production process & regulatory guidelines.
Discover the potent reprogramming mix, CRISPR gene editing tools, and iPSC bank generation services.
Unveil the current manufacturing approaches for LVV and its deployment in cell therapies.
With our extensive experience in FDA/EMA/NMPA compliance, 150+ GMP batches, and +20 IND track records, uBriGene is your trusted CGT CDMO partner.
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