Determination of physicochemical properties for protein therapeutics or other biologics, determined in line with ICH Q6B, EMA and FDA guidelines including molecular weight, isoform, electrophoretic, chromatographic and spectroscopic profiles
Determination of the physicochemical properties of a protein therapeutic allows the relevant specifications to be established. Understanding the physicochemical properties of a biologic also supports drug development and ongoing quality control. A range of methods and technology are required to determine these properties for your specific protein - the challenge is to select and adapt the most appropriate technical approaches for the product in question.
Our scientists deliver protein physicochemical property analytical programs in line with appendix 6.1.2 in the ICH Q6B guidelines: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. Our programs are designed to optimise the data required to determine or confirm identity, explore patterns of heterogeneity and demonstrate consistency in quality for the drug. We are adept at method development and conduct phase-appropriate validation of methods where required.
We apply our Total Quality Assurance expertise to developing, validating and conducting physicochemical testing programs that can expedite your protein characterisation programs, helping you to meet your development and submission milestones.
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