In-depth protein analysis in accordance with the ICH Q6B guidelines including structure, physicochemical properties, potency, impurities and concentration
Proteins can present significant analytical characterization challenges. To ensure product quality and consistency, our biopharmaceutical analysis experts provide protein, peptide, glycoprotein and protein conjugate analysis services which are offered in accordance with the requirements of the ICH Q6B Guidelines, Specifications: Test Procedures and Acceptance Criteria for Biotechnological / Biological Products.
Intertek's capabilities help to address the requirements for a "well characterized" or specified biological drug product or drug substance and include thorough product characterization during development, raw material testing, in-process testing, stability testing and batch release testing.
Structural Characterization and Confirmation:
Advanced protein analysis services:
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