Identity, Purity and Quantity
Do you need analytical characterization of a protein biopharmaceutical?
Alphalyse offers a range of protein analysis services for research, manufacture, pre-clinical and clinical development of protein biopharmaceuticals. This includes analyses specifically designed for monoclonal antibodies, vaccines, antigens and allegens, recombinant proteins and biosimilars.
The analysis principles for protein identity, purity & impurities, and quantity, are described in The ICH Q6B Guideline: “Test Procedures and Acceptance Criteria for Biotechnological/Biological Products”.
Alphalyse provides protein analytical characterization for:
- Process development
- Comparability between batches and reference standard
- Product related impurities and degradation products
- Host cell protein identification
- CMC documentation for regulatory authorities; EMA, FDA
- Pharmacokinetic/Toxicology bioanalysis in GLP compliance
Read more about analytical characterization of:
And our unique protein assays: