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Biopharmaceutical aggregation, either by physical association or by the formation of covalent bonds, can have serious implications for the clinical safety and efficacy of a biopharmaceutical. Such aggregates can form at any stage of the development or manufacturing process. Efficacy or loss of activity can be severely compromised by aggregation, especially if the active site(s) become masked due to aggregation behaviour.
Advanced Analytical Techniques
(*CD and AUC data is generated with a partner laboratory - Intertek includes the QA audit for formal regulatory studies).
All techniques above are available as part of a cGMP compliant program. Intertek also has access to a UK Consortium that helps develop technology to address detection of aggregation states in biopharmaceutical processing. Intertek is equipped to handle Class I and Class II Biological Agents (e.g. live viral vectors used in vaccines and gene therapy products).
Request more information to see how Intertek can help your organization with Aggregation State Characterization.
