Quality by design workflow and tools provide a systematic and consistent approach that helps with commercialization of products under accelerated timelines. QbD principles guide the teams to access the risks associated with product quality attributes and develop an effective control strategy for risk mitigation and management. QbD starts at a very early stage in the life cycle of a program. For the monoclonal antibody program being discussed a preliminary product quality attribute (pPQA) list was generated soon after discovery. Prior to the start of commercial process development, a commercial quality target product profile (QTPP) was updated, and a product quality attribute risk assessment performed based on its impact on safety and efficacy. Before initiating upstream process characterization (PC) studies, a parameter level risk assessment of the impact on PQA’s and process performance was done. The high and medium risk parameters from each upstream unit operation were studied as part of PC. The experimental studies were conducted in ambr 250<sup>TM</sup> which was qualified as a scale down model. The study designs and results from the executed experiments will be shown. The output of these studies will be used to develop the upstream process control strategy where the process parameters will be classified along with their acceptable ranges

Application of quality by design tools to guide upstream process characterization studies for a monoclonal antibody program

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.