The implementation of platform manufacturing processes enables new products to be accelerated from discovery to the clinic, and ultimately to the market. GSK has defined a platform drug substance manufacturing process for new monoclonal antibody (mAb) products that enables rapid transfer from the lab to clinical manufacturing, and subsequent transfer to commercial manufacturing with minimal changes in scale and equipment.  Quality by Design enables further acceleration when knowledge gained from implementation of the platform process is used to develop platform process control strategies.  The development of a platform raw material risk assessment is presented as a case study in leveraging larger data sets available from the implementation of the platform processes to address the challenges of robust mAb control strategy development in an accelerated environment.  The benefits include: 1) significantly reducing the resources required to complete a key component of platform mAb control strategy, 2) identification and mitigation of raw material-related risks to the platform process and 3) prioritization of raw materials in support of raw material supply chain workstreams.

Enabling acceleration:  Case study in leveraging platform data sets to establish a platform raw material control strategy

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.