Stability
Stability
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 AG 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.
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Commonly used analytical techniques employed for Stability Studies |
Protagen AG Offers |
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Amino acid analysis |
✔ |
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Aggregation analysis |
✔ |
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Capillary electrophoresis |
✔ |
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1D, 2D SDS PAGE reducing/non-reducing |
✔ |
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Isoelectric focusing |
✔ |
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Western Blotting |
✔ |
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Glycosylation analysis |
✔ |
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Peptide mapping |
✔ |
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Post-translational modifications (PTM) |
✔ |
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S-S bridge analysis |
✔ |
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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 AG
 |
Dr Katja AschermannHead of Business Development Protein Services. Phone: +49 (0) 231 9742-6300 |