Stability studies are a critical step in the drug development process and any delays in this process will adversely affect submission dates. The active involvement of an experienced partner can offer significant benefits. 

Protagen Protein Services GmbH has excellent technical knowledge and long-standing experience in performing stability studies for biopharmaceutical products. Typical studies performed are:

  • Accelerated stability studies
  • Degradation testing
  • Stress testing
  • Short and long-term testing
  • Orthogonal stability indicating techniques

A diverse range of analytical techniques is often required to determine the stability profile of a biopharmaceutical product, some of which are listed in the following table.

Commonly used analytical techniques employed for Stability Studies

Protagen Protein Services GmbH Offers

Amino acid analysis

Aggregation analysis

Capillary electrophoresis

1D, 2D SDS PAGE reducing/non-reducing

Isoelectric focusing

Western Blotting

Glycosylation analysis

Peptide mapping

Post-translational modifications (PTM)

S-S bridge analysis

Liquid chromatographic patterns

Protein quantification

Spectroscopic profiles

Via Partner

The requirements for a stability study are described in ICH Topic Q1A (R2) – Stability Testing of new Drug Substance and Products and ICH Q5C – Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products.

Your contact for Stability at Protagen Protein Services GmbH

Thomas Flad

Dr. Thomas Flad

Director Business Development
Our business development team will be happy to assist you with your project.

Phone: +49 (0) 231 9742-6100