Analytical Excellence—Enabling Tomorrow’s 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.

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’s unique capabilities in vector safety, integration site analysis, and bioinformatics were added to our portfolio, establishing ProtaGene.

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.


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’s and cell and gene therapy companies turn to ProtaGene for both in-depth expertise and its range of capabilities.

Complete Product Life Cycle Support from Discovery to GMP

The ProtaGene team is dedicated to understanding our clients’ 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.

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’ 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—from characterization through commercial testing, from pre-IND/IMPD to market approval.

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.

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’ path to market.

Committed to Reaching Your Development Milestones

Dedication to delivery and quality-system-driven data integrity are cornerstones of ProtaGene’s organizational values. We believe in transparency, making realistic commitments, and delivering results on time. When challenges are encountered, we discuss them with our clients and define a course of action to solve the problem. This willingness to solve problems always demands direct attention, communication, and flexibility to adjust course as needed— qualities inherent to the ProtaGene organization.

Our History

ProtaGene is a Unification of Expertise in Protein, Gene, and Cell Therapy Analytics

Protagen Protein Services, BioAnalytix, and Genewerk independently embarked on their journeys in advanced protein and gene therapy-based analytics and then came together to integrate their understanding, platforms, and quality processes to commercialize therapeutics to treat patients in need.

The road through therapeutic platform development is frequently challenging and full of unknowns, especially as advancements in protein and gene-based therapeutics require new expertise, new technologies, a commitment to analytical excellence, and complete quality systems across the globe.

In this, our involvement and successful accomplishments over nearly three decades have given us the confidence and experience to know that ProtaGene will rise to the challenges of tomorrow’s therapeutics so we may continue to help enrich the health and lives of patients around the world.

1997 1998 2001 2005 2006 2012 2013 2016 2014 2019 2020 2021 Protagen GbR was founded as a spin-out from Ruhr-University, Bochum as a protein analysis services company by three scientists and Martin Blüggel. LAM-PCR, the then gold standard for vector integration site analysis developed by Dr. Manfred Schmidt, one of Genewerk’s founders, was used in the first Europe-wide gene marking trial in Chronic Myelogenous Leukemia (CML) patients. GeneWerk’s founding team was involved in the safety assessment of Glybera, the first approved gene therapy drug in a western country. GeneWerk GmbH was founded in July 2014 by Prof. Dr. Christof von Kalle, Dr. Manfred Schmidt and Dr. Annette Deichmann. Protagen Protein Services GmbH (Dortmund, Germany) merges with Panatecs GmbH (Heilbronn, Germany) to increase capacity and capabilities. Protagen Protein Services GmbH (PPS) and BioAnalytix Inc., based in Cambridge, USA, merged to establish an integrated global contract research organization for providing best-in-class analytics in biopharmaceuticals. Protagen Protein Services GmbH (PPS) merges with GeneWerk to integrate leading protein and gene therapy analytic platforms. GeneWerk secured a growth equity investment from Ampersand Capital Partners and established its US entity. Protagen AG performs its first biosimilar analytics to define the quality target of an authorized biological product. Protagen AG successfully presents a release testing concept for an autologous tumor vaccine to EMEA biotech working party. Protagen AG awards its GMP certificate for performing protein analytical testing. BioAnalytix was founded out of the Barnett Institute by Barry Karger, Rob Garnick, Billy Wu (CSO), and Kirt Poss (CEO) to work with leading pharma companies in advanced biologics development. Protagen Protein Services (PPS) GmbH continuously expands its service portfolio to become a full-service provider for protein analytical testing.

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