ProtaGene CGT GmbH (former GeneWerk GmbH) is part of the world-leading analytic CRO ProtaGene which is partner for the biopharmaceutical and cell and gene therapy industries. As pioneers and industry leaders, we are setting the standards for vector safety and integration site analysis in preclinical and clinical development of gene therapies. Our strong bioinformatics as well as research and development capabilities complement the portfolio needed by our clients. GeneWerk’s founders were leading experts in the field and involved in the safety assessment of many cell and gene therapy drug products, including Glybera®, the first gene therapy drug product approved in the western countries for treating Lipoprotein Lipase Deficient (LPLD).

For more than 20 years, the team has worked alongside clients around the world and from research through product commercialization to develop novel cell and gene therapies that meet regulatory safety requirements. Our clients rely on our deep scientific, technical and regulatory expertise to de-risk their cell and gene therapy development pathway.

As a credible partner with proven expertise in the field, we function as an extension to the client’s internal teams to bring breakthrough therapies in development to market authorization.