Quality by Design for Effective Bioprocess Characterisation and Validation (MBI® Training, Bioprocess Industries)

Teaching is in small classes, with an emphasis on interactive problem solving and case studies.

Each day will cover the following topics:

• Quality by Design: the enhanced route for process development
• PAT challenges for bioprocessing
• QbD: current industry practices and regulatory expectations
• The Roche Genentech QbD approach
• Workshop: comprehensive QbD efforts for a new product

• QbD in fermentation: an industrial view
• QbD applied to process characterisation of purification processes
• QbD challenges with continuous perfusion cell culture
• Process changes: pre and post product approval - case studies and approaches
• Application of QbD principles to the development and technology transfer of a major process improvement for the manufacture of a recombinant protein
• QbD applied to cell therapies
• How QbD informs the PV end game: how PV is impacted by FDA process validation guidance
• Workshop: what is the relationship between extent of process change and the revalidation needs?

• Workshop: FDA inspection role play
• Application of QbD to tangential flow filtration processes
• Ultra scale-down tools linked to process modelling for QbD
• Workshop: how to perform a tangential flow filtration QbD study
• Workshop: process validation for the production of biotherapeutics based on industrial case studies

• Case study: integrating QbD into bioprocess characterisation and validation

A social networking event will be held for delegates and speakers.