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.
The testing at Protagen Protein Services (PPS) will be performed according to ICH Q1A and ICH Q5C. They are performed under real storage conditions during several phases of development, like early development, clinical studies, market authorization and monitoring of the authorized market product.
PPS 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
1D, 2D SDS PAGE reducing/non-reducing
Post-translational modifications (PTM)
S-S bridge analysis
Liquid chromatographic patterns
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.
Light exporsure, temperature, humidity
Photostability testing at PPS will be performed according to ICH Q1B, option 2 by direct measurement of the accumulated radiation under temperature- and humidity controlled conditions. ICH Q1B, option 2 implies that the same sample is exposed to cool white fluorescent as well as near UV lamp.
Determination of photostability is required throughout the entire development of biopharmaceuticals, starting with drug substance to the final product in its primary and secondary packaging.
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
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