Cell and Gene Therapy CRO Services | uBriGene

uBriGene is a global leader in advanced therapy medicinal products (ATMPs), cell and gene therapy CDMO services, and analytical testing. Headquartered in Maryland with operations across North America and Asia, the company specializes in bridging ATMP concepts from early discovery through commercialization.

Core Services

Cell and Gene Therapy CDMO: Robust platforms optimized for high quality and productivity, specializing in plasmids, mRNA-LNP, sgRNA, viral vectors (AAV, lentivirus, adenovirus), and cell therapy products including CAR-T, CAR-NK, iPSC, MSC, and TIL therapies.

CRO Services: Discovery and preclinical study support with production services for plasmids, mRNA-LNP, sgRNA, and viral vectors.

Analytical Development & Testing: State-of-the-art technologies and quality infrastructures ensuring product integrity and regulatory compliance, including cell therapy potency analytical development and GMP testing.

Cell and Gene Therapy Products: Ready-to-use R&D and GMP-grade products including plasmid products with activated Drug Master Files (DMF), AAV empty capsids in various serotypes, lentiviral vectors (GFP, GFP-Luciferase, CD19-CAR), iPSC generation products with mRNA-LNP reprogramming cocktails, and Ubrinuclease enzyme products.

Infrastructure & Track Record

• 6 Centers of Excellence for manufacturing and testing
• >150 GMP batches successfully delivered
• 20+ INDs filed and accepted with FDA, EMA, and CDE
• Perfect audit record from over 100 clients
• State-of-the-art GMP facilities with integrated technology platforms

Expertise

Extensive experience in manufacturing, QC testing, and regulatory filing across preclinical studies, IND enabling, and commercialization stages. The company emphasizes innovation, quality systems, client-centric collaboration, and local accessibility on a global basis.