Analytical Excellence\u2014Enabling Tomorrow\u2019s Therapeutics :
ProtaGene is a world-leading CRO partner for the biopharmaceutical and cell and gene therapy industries. From research through product commercialization, we provide the most advanced, integrated, and complete protein and gene analytic capabilities and packages for biologic therapeutics as well as cell and gene therapy platforms.<\/p>\n\n\n\n
Our deep history of analytical leadership in protein-based therapeutics stems from the merger of Protagen Protein Services in Europe and BioAnalytix in the US. In 2021, GeneWerk\u2019s unique capabilities in vector safety, integration site analysis, and bioinformatics were added to our portfolio, establishing ProtaGene.<\/p>\n\n\n\n
Our combined protein- and gene-based analytical platforms make it the leading analytic service provider across the biopharmaceutical and cell and gene therapy development spaces. The organization operates four sites in Europe and North America and works in advanced therapeutic platforms with leading biopharmaceutical and gene therapy companies worldwide.<\/p>\n\n\n\n
Overview
Protein, Gene, and Cell Therapy Expertise to Accelerate Next-Generation Therapeutics :
The combination of excellence in protein, vector, gene expression, and genetic analytics offers a unique and comprehensive collection of capabilities and expertise. Organizations ranging from leading international pharmaceutical companies to emerging biopharma\u2019s and cell and gene therapy companies turn to ProtaGene for both in-depth expertise and its range of capabilities.<\/p>\n\n\n\n
Complete Product Life Cycle Support from Discovery to GMP :
The ProtaGene team is dedicated to understanding our clients\u2019 platforms and objectives, including CMC development challenges and regulatory strategy opportunities. We help solve problems to de-risk and accelerate your programs, regardless of where an asset is within its development journey. While the issues encountered will be different along the development journey, our team designs and implements solutions, from research to market.<\/p>\n\n\n\n
Dedication to Quality Supports Robust Regulatory Packages :
ProtaGene is experienced in numerous regulatory processes for biologics and gene therapy packages in Europe and the US. This expertise provides a deep context for defining and developing the most effective pathways and strategies with regulatory agencies. Our dedication to quality in assay protocols and data management allows us to smoothly navigate our clients\u2019 assets through the regulatory process. Based on our established quality management system and GMP-certified contract laboratory services, ProtaGene works hand-in-hand with clients at every stage of their regulatory journey\u2014from characterization through commercial testing, from pre-IND\/IMPD to market approval.<\/p>\n\n\n\n
Global Presence De-risks and Accelerates the Path to Market :
With state-of-the-art labs and advanced quality systems in Burlington, Massachusetts, USA, and Dortmund, Heilbronn, and Heidelberg, Germany, ProtaGene is well-positioned to serve our international customer base. While we are experienced working with the full complement of leading global regulatory bodies, we have extensive expertise working with the FDA and EMA.<\/p>\n\n\n\n
In-depth regulatory knowledge and positive working relationships with key regulators allow us to create regulatory packages that minimize regulatory barriers and accelerate our clients\u2019 path to market.<\/p>\n\n\n\n