uBriGene provides analytical assay development (AD) and quality control (QC) testing services supporting in-process and final product release testing of your CGT and advanced therapy clinical programs.
uBriGene offers integrated CDMO services to support cell and gene therapy product developers including tech transfer, process and analytical development, scale-up, GMP-readiness, and regulatory support.
Compendial and qualified analytical assays and testing in compliance with regulatory standards to ensure the safety and efficacy of plasmids and mRNA.
Plasmids & mRNA AD/QC ServicesA full suite of analytical assays and in-process and final release testing for AAV, LVV, AdV, and oncolytic virus, qualified and compliant with regulatory standards.
Viral Vectors AD/QC ServicesAnalytical assay development and QC testing services for cell therapy products, including CAR-T, CAR-NK, iPSC, MSC, and TIL, covering in-process, final product release, and functional potency assays.
Extensive experience in storage and stability studies for advanced therapy critical materials, drug substances, and drug products.
Centers of Excellence for manufacturing and testing
GMP batches successfully delivered
INDs filed and accepted with FDA, EMA, and CDE
Centers of Excellence for manufacturing and testing
GMP batches successfully delivered
INDs filed and accepted with FDA, EMA, and CDE
