Quality by Design for Effective Bioprocess Characterisation and Validation
Get expert guidance on choosing on how best to integrate QbD, DoE and PAT into lifecycle approach to process characterisation
22-25 February 2016
A series of stimulating interactive lectures from experts in the field and teamwork activities will enable you to:
• Learn about the latest FDA and EMEA regulations with regards to QbD, PAT, process characterisation and validation.
• Understand current and future perspectives of the impact of QbD and PAT on the effort required for process characterisation.
• Learn how to perform Risk Assessments to determine Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).
• See examples of how to combine scale-down models with historical knowledge and DoE to map out Design Space.
• Understand the principles behind the characterisation and validation of unit operations, such as fermentation, filtration, chromatography, formulation through to supply chain logistics.
• Learn how to apply QbD to continuous operations, e.g. perfusion culture and filtration operations.
• Explore the impact of single-use components on validation needs
• Apply QbD when implementing pre/post-approval process changes.
Who should attend?
This module is suitable for scientists and engineers working in the biotech sector that are involved or liaise with people in Process Development, Process Characterisation, Validation, Manufacturing, Quality and Regulatory activities.
• Quality by Design – concepts and application for the biotech industry
• PAT challenges for bioprocessing
• FDA QbD pilot with industry biotech working group - A-Mab case study
• How QbD informs the process validation end game
• Workshop: comprehensive QbD efforts for a new product
• QbD in fermentation: an industrial view
• Application of QbD to membrane processes and single-use systems
• Workshop: single-use versus reuse, comparative validation challenges
• QbD applied to process characterisation of purification processes
• Workshop: what is the relationship between extent of process change and the revalidation needs?
• Workshop: FDA inspection role play
• QbD characterisation of continuous perfusion cell culture for CMC packages
• Industrial case studies: QbD application to major process improvements pre and post approval
• QbD applied to cell therapies
• Current industry practices and regulatory expectations
• Workshop: Process Validation for the Production of Biotherapeutics: Case Studies
• Case study: integrating QbD into bioprocess characterisation and validation
Dr Suzanne Farid, UCL
Dr Richard Francis, Francis Biopharma
Invited Expert Speakers
Suzanne Aldington & Louise Ingram, Lonza Biologics plc
Paul Bird & Angus Thompson, Fujifilm Diosynth Biotechnologies
Mairead Looby, Pfizer
Graham McCartney & Matt Osborne, Eli Lilly
Anthony Newcombe, Parexel International
Patrick Sheehy, Janssen Biologics
Tim McCoy, Genzyme
Stephen Ward, Cell Therapy Catapult
Ron Wheeler, Promega
John Woodgate & Aloke Dey-Chowdhury, Pall Life Sciences
A networking dinner will be held on the first evening.
Module cost TBC.
Page last modified on 13 may 15 14:19