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is a world-leading CRO, offering cell and gene therapy and biopharmaceutical services to the markets. 25 years of experience in that field and our comprehensive spectrum of analytical methods, ready to be applied at all stages of product development and throughout the whole product life cycle, ensure highest quality to our customers in the pharmaceutical, biotech and life science industry. Since 2021, ProtaGene unites the expertise of the former Protagen, BioAnalytix and GeneWerk under one roof, combining three legacy entities into a single, globally integrated business that melds protein science and analytics expertise with vector safety, integration site analysis, and bioinformatics. Thereby, we are able to provide analytical approaches entirely tailored to our customers’ needs e.g. for safety assessments in preclinical and clinical trials and for characterizing CGT and biopharmaceutical products. Analysis is performed in a GMP/GCP/GCLP compliant environment.

Analytical Reports

are regularly accepted by multiple regulatory authorities worldwide such as FDA (USA), EMA (EU) and others, including all stages of development from scientific advice to phase I – III, and up to market authorization. By means of standard and innovative analytics, we focus on delivering analytic excellence in advancing, de-risking and accelerating all stages of drug development. Analytical services include a broad spectrum of technologies from glycosylation and impurities analysis up to MS-based approaches like MAM and HCP-MS, integrating innovative areas such as HDX-MS, in-vivo CQA mapping and Integration Site Analysis (ISA) to determine the integration site position and frequency of viral vectors with unmatched precision and sensitivity.

ProtaGene’s Genomics Capabilities for Gene Therapy Trials

provide best-in-class molecular  analysis services and long-term follow-up to ensure the safety of novel cell and gene therapies focusing on insertional mutagenesis and genotoxicity. Highly sensitive platforms and bioinformatics tools determine fusion sequences adjacent to known DNA or RNA fragments in minimal tissue samples down to the single cell level. Applications include clonality and safety of (viral) vectors in gene therapy, on-target specificity of designer nucleases, immune repertoire studies in T cells and B cells and next generation sequencing (NGS). Based on our unique worldwide experience in gene therapy studies, bioinformatics, NGS, and associated regulatory demands we help our customers by designing individual solutions.

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