Protagen Protein Services

Protagen Protein Services (PPS) is a world leading CRO and recognized expert in mass spectrometry methods for analytical services in protein science. More than 20 years of market experience and the comprehensive spectrum of validated analytical methods ensure the highest quality for customers in the pharmaceutical, biotech and life science industry with focus on Biopharmaceuticals and Biosimilars.

Biopharmaceuticals: PPS provides a strategic approach for characterizing Biopharmaceutical products. In a GMP compliant environment PPS provides the full range of services from drug discovery, development, release testing and regulatory compliance under ICHQ6B, for all Biopharmaceuticals that are developed, such as Antibodies, Bi-specifics and other formats as New Biological Entities (NBE).

Biosimilars: PPS has successfully supported over two dozens of different customers in multiple projects to develop Biosimilars. The analytical reports on Biosimilars and Biobetters has been accepted by multiple regulatory authorities worldwide including e.g FDA (USA), EMA (EU), ANVISA (Brasil) and MFDS (Korea) during all stages of development.

In order to find out how PPS can help you move your research from clone to clinic, please contact us via contact@protagenproteinservices.com

Analytical Service Leaders in Biopharmaceutical and Gene Therapy Development Unify Operations and Re-brand as ProtaGene

Heilbronn & Heidelberg, Germany and Boston, USA - January 12, 2022: Following the announced merger in July 2021, Protagen Protein Services GmbH, BioAnalytix, Inc., and GeneWerk GmbH today announced their unified operations and re-brand as ProtaGene, a world-leading CRO partner for the biopharmaceutical and cell & gene therapy industries.

Biosimilar Drug Development the analytical strategy is keyfactor for your success

Heilbronn/Dortmund March 2019: The generation of analytical data for the comparison between a biosimilar and the originator product is the initial assumption in the development of biosimilars. Achieving Biosimilarity can be a controversial and complex topic when deciding the right time point and range of analytics.

Protagen Protein Services expands analytical Service Spectrum in Biosimilar Development Support

Heilbronn/Dortmund February 2019: The success or failure of the development of a biopharmaceutical product is also governed by protein stability. Protein stability is considered a critical parameter during manufacturing, production, formulation, long term storage, efficacy, and delivery to patients. To meet our customer demands now and in the future, PPS always invests in new analytical...

Protagen Protein Services (PPS) reaches new level in characterizing HCP protein impurities

In response to current regulatory guidance a Mass Spectrometry (MS) based Host Cell Protein (HCP) detection approach with faster, more accurate and wider-ranging detection is essential. In order to meet the newly prevailing demands Protagen Protein Services (PPS) recently invested in more far-reaching MS capabilities: The new high-performing mass spectrometer ThermoFisher Q Exactive™ HF-X started...
Protagen Protein Services (GmbH), Inselwiesenstraße 10, D-74076 Heilbronn

+49 231 9742 61 00