Posted on: 19th December 2016

Quality by Design (QbD) in process development and streamlining characterization and validation, proved fruitful topics for discussion and sharing experience and best practice at BPDG18 in Montreux, Switzerland in November 2016.

Six case studies were presented to illustrate current approaches to QbD in process development, including Kartik Subramanian, Principal Scientist, Manufacturing Services at AbbVie, who shared a case study on developing a robust control strategy for an accelerated program. He highlighted the steps taken starting from the pre-characterization risk assessment; developing a scale down model when you have no experience; and step three process characterization from univariate to multivariate analysis. John Eschelbach from Roche discussed the application of a QbD approach to control system design for a monoclonal antibody and how they went about implementing it at Roche.

Development Group’s Elaine Stokes gave an overview of the QbD survey – Process Development Streamlining; Process Characterization & Validation. The survey had collected valuable responses from the point share members on the approach to QbD, critical quality attributes (CQAs), design space and process characterization, the consequences of accelerating validation and the data used for validation.

Three case studies were presented to illustrate current approaches to streamline process characterization and validation. Phillip Smith, GSK, shared information on the management of the process control strategy post PPQ, Seth Kitchener and Bob Herbst, Immunogen, discussed acceleration of process characterization for an antibody drug conjugate and Martin Scholler, Shire, talked about using a MAb case study to question efficiency gains.

The ongoing program of collaboration for 2017 was agreed at a later meeting on 7 December 2016, including two new pointshares – Outsourcing and IND Enabling Toxicology Material; whilst five white papers are currently in production and on track for publication in 2017, from the Host Cell Protein teams, Formulation, Monoclonality, Qualification of Scale Down models and Forced Degradation teams.

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