Bioanalytix

BioAnalytix, Inc., a US-based advanced analytics and data analysis firm, merged with Protagen Protein Services GmbH and GeneWerk GmbH to form ProtaGene, a contract research organization (CRO) serving the biopharmaceutical and cell and gene therapy industries. The merger of Protagen Protein Services and BioAnalytix occurred in April 2019, with GeneWerk joining the group in 2021. ProtaGene provides comprehensive analytical services for biological therapeutics and cell and gene therapy platforms, spanning from discovery to commercialization. The company offers integrated protein and gene analytic capabilities, including vector safety, integration site analysis, and bioinformatics. ProtaGene's services encompass protein science, advanced analytics, data analysis, and regulatory support for biopharmaceutical development. The organization operates four sites across Europe and North America, working with leading biopharmaceutical and gene therapy companies worldwide. ProtaGene's expertise includes protein, vector, gene expression, and genetic analytics, with teams focused on addressing CMC development challenges and regulatory strategy opportunities. The company's quality management system and GMP-certified contract laboratory services enable it to support clients throughout their regulatory journey, from pre-IND/IMPD stages to market approval.

Key customers and partnerships

ProtaGene works with large, leading, public pharmaceutical, biotechnology, and cell and gene therapy companies, targeting multiyear programs. The company collaborates with biopharmaceutical and gene therapy innovators, providing ongoing expert analytical support and candidate assessments based on high-quality data throughout various phases of development. ProtaGene has experience working with global regulatory bodies, particularly the FDA and EMA, which allows the company to create regulatory packages that minimize barriers and accelerate clients' path to market.