Biopharmaceuticals

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:

• Vaccines
• Monoclonal antibodies
  
  

And our unique protein assays:

• Pharmacokinetic Assay
• Host Cell Protein Assays