To ensure Data Integrity Protagen Protein Services GmbH uses a multi-aspect approach.
The technical aspects as handling of user rights, the nomination of system administrators or the requirement for an audit trail (CFR part 11) is as important as the behavior of every single employee we hire. Besides this, our processes and training program is designed in a way, that data integrity is ensured.
Protagen Protein Services (PPS) is a world leading CRO and recognized expert for analytical services in protein science regarding characterization, method development, validation and routine testing of antibodies, proteins, vaccines and other formates of biopharmaceuticals. Our sites are equipped with modern, state-of-the-art equipment for the analytical characterization of biopharmaceuticals regarding structure, purity, chemical modification, aggregation, particle formation, thermal stability e.g.. We offer service modules for analytcal support from research to approval regarding:
- Clone Selection & Process Development
- Extendend Characterization & Comparability
- Stability & Release