Analytical Excellence — Enabling Tomorrow’s Therapeutics

ProtaGene is a world-leading Contract Research Organization (CRO) specializing in advanced protein and gene analytic solutions for the biopharmaceutical and cell and gene therapy industries. With more than 25 years of experience, we support clients across all stages of therapeutic development—from early research and preclinical studies through clinical trials, regulatory submissions, and commercial release.

Formed through the integration of Protagen Protein Services, BioAnalytix, and GeneWerk, ProtaGene combines deep scientific expertise with cutting-edge technology. Our unique platform blends state-of-the-art protein characterization with industry-leading gene therapy analytics, including vector safety assessments, integration site analysis (ISA), biodistribution, vector copy number, shedding studies, and bioinformatics.

Operating from four global sites in Europe and North America, ProtaGene provides GLP, GCLP, and GMP-compliant services. Our data packages have supported over 50 clinical trials and numerous regulatory submissions, including landmark approvals such as Glybera, Strimvelis, Kymriah, and Zynteglo. Our analytical reports have been accepted by agencies including the FDA, EMA, ANVISA, and MFDS.

We pride ourselves on collaborative partnerships, customer-focused project management, and the flexibility to develop customized workflows tailored to each client’s unique research and regulatory goals. Whether advancing a novel biologic or a groundbreaking gene therapy, ProtaGene delivers the quality, insight, and experience needed to bring tomorrow’s therapeutics to life.