Quality is embedded in every detail
Quality

Our Philosopy for Quality

Protagen Protein Services (PPS) is a GMP-certified contract laboratory with focus on protein analysis. The safety of the patient is always our leading goal.
Quality is key to our business and since the founding of PPS, 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 / 2019 

Local authority grants GMP Certifcate  

Annual

Multiple Customer Audits

 

PPS 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 dedicated to providing the highest quality analytical services. Clients benefit from our:

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

 

Quality is enshrined in the mindset of every single one.

PPS 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 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.

SERVICES

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:

  • Developability
  • Clone Selection & Process Development
  • Extendend Characterization & Comparability
  • Stability & Release

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Protagen Protein Services (PPS) is a world leading CRO and recognized expert 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.

PPS supports Biosimilar developers with a broad range of analytical methods and consulting in achieving and demonstrating Biosimilarity

LATEST NEWS & EVENTS

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