Invited Speakers:
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IBC’s 4th Annual Analytical Method Validation gives assay development and validation scientists an indication of how qualification and validation activities are performed across the industry. The Second Annual Biophysical Analysis for Bioprocessing, will feature problem solving case studies of the characterization of product variances, proteins for liquid formulations and MAbs from different cell lines as well as recent progress in biophysical methods for product analysis and characterization, with emphasis on AUC, FFF and image-based methods. IBC’s 5th Annual Process Quality Forum Process Characterization and Control is an event more broadly focused on the use of process characterization and control to biologics manufacturing. The meeting will reinforce manufacturing quality concepts being promoted by the USFDA in its “Quality Systems Approach” guidance (September 2006); ICH (International Council on Harmonization) guidances Q8 (Pharmaceutical Development), Q9 (Risk Management) and Q10 (Quality Management); and the US and EU Pharmacopoeias.
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