Protagen Protein Services GmbH is a GMP-certified contract laboratory with focus on protein analysis.

Quality is key to our business and since the founding of Protagen Protein Services GmbH, quality has remained a mainstay of corporate culture:

Date Quality Milestone Established
1997 Foundation
2003/2004 First SOPs / Validation
Establishment of QM System
2006/2010/2013/2016 Local authority grants GMP Certifcate
Annual Multiple Customer Audits


Protagen Protein Services GmbH has established a quality management system that oversees aspects of our processes and meets the requirements of the EU GMP Guide concerning:

  • Precise Instructions
  • Traceable Documentation
  • Document Control
  • Intensive Training Programs
  • Comprehensive Inspection Programs
  • System for Qualification of Equipment, particularly Computerized Systems based on GAMP

Protagen Protein Services GmbH is inspected by Bezirksregierung Arnsberg, Germany who have certified that Protagen Protein Services GmbH may conduct testing according to Sect 14 para 4 No.3 of the German Drug Law (GDL) to perform quality testing on medicinal products for human use. This approval covers the testing procedures of protein analysis.

Protagen Protein Services GmbH is dedicated to providing the highest quality analytical services. Clients benefit from our:

  • Excellent technical knowledge
  • Long-standing experience
  • Peer-review reports

Protagen Protein Services GmbH offers a broad spectrum of qualified analytical equipment and validated methods. We have the expertise to develop and validate client specific methods.

Protagen Protein Services GmbH has successfully introduced technology to the regulatory authorities and received excellent feedback for its quality system from frequent audits by its renowned clients.

Our experienced team offers a wide range of support including analytical method development, method validation, method transfer, stability testing and release testing on biopharmaceutical products.

To keep up to date with the GMP requirements, Protagen Protein Services GmbH is a member of DGGF (German Society for Good Research Practice) and EAPB (European Association of Pharma Biotechnology). For us, the scientific information and opinion exchange and the promotion of education, as well as the contact for national and international organizations is important.


Your contact for Quality Management at Protagen Protein Services GmbH


Alexandra Schmalenbach

Director Quality Management

Phone: +49 (0) 231 9742-6100