As a cell and gene therapy CDMO provider, uBriGene prioritizes quality and meets the highest quality standards and regulatory compliances. Our mission is to deliver safe, reliable ATMPs that fulfill global regulatory expectations.
Our robust quality management system aligns with GMP standards set by ICH, FDA, EMA, and NMPA, ensuring that every product meets stringent safety and quality requirements.
Stringent Quality Control: Comprehensive testing and validation ensure CGT products meet rigorous standards for safety, efficacy, and consistency throughout production.
Regulatory Compliance: Adherence to global guidelines (FDA, EMA, CDE) ensures CGT products comply with relevant laws, enhancing safety and market approval.
Robust Documentation: Detailed records of the CGT product lifecycle ensure traceability, accountability, and facilitate regulatory inspections and audits.
Continuous Improvement: Regular audits and updates incorporate scientific and regulatory advancements, ensuring ongoing enhancement of quality systems in CGT.
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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 requirements.
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 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.
Learn how uBriGene can be your bridge from ATMPs concepts to commercialization.
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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