Determination of physicochemical properties of proteins, antibodies or other biological products in line with ICH Q6B, EMA and FDA guidelines
Determination of physicochemical properties for a biologics such as proteins by appropriate techniques is necessary to allow relevant specifications to be established and support biologic development and ongoing quality control of products.
A range of methods and technology are required to determine the physicochemical properties of your specific desired product. The challenge is to select and adapt the most appropriate technical approaches to 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 of the drug substance.
We are adept at method development and phase-appropriate validation where required.
Our expertise in developing, validating and conducting physicochemical testing combined with range of techniques makes Intertek the perfect partner to expedite your protein structural characterisation programs to meet your development, submission or ongoing processing needs.
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