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
25 -28 February 2013
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 studies.
- Understand how to adopt a lifecycle approach to process characterisation and validation to obtain deeper process understanding.
- 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 and chromatography.
- 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 the Process Development, Process Characterisation, Validation, Manufacturing, Quality and Regulatory activities.
Programme
Monday 25 February
• Quality by Design – Concepts and Application for the Biotech Industry
• PAT Challenges for Bioprocessing
• Lifecycle Approach to Process Validation
• 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
Tuesday 26 February
• QbD in Fermentation: An Industrial View
• Implementing Single-use Systems: Validation and Design Considerations
• Membrane Processes: Application of QbD to CHO Cell Clarification
• Workshop: Single-use versus Reuse, Comparative Validation Challenges
• Chromatographic Separation:QbD Applied to Process Characterisation
• Workshop: What is the Relationship between Extent of Process Change and the Revalidation Needs?
Wednesday 27 February
• Workshop: FDA Inspection Role Play
• Formulation and QbD
• Supply Chain Logistics of an Antibody-Drug Conjugate
• Industrial Case Study: QbD Application to Major Process Improvements Post Approval
• Industrial Case Study: Presenting Pre and Post Approval Changes to Regulatory Authorities
Thursday 28 February
• Case Study: Integrating QbD into Bioprocess Characterisation and Validation
Module Leaders
Suzanne Farid UCL
Tim Hughes CSL Ltd
Academic Staff
Mike Hoare UCL
Invited Industrial Speakers include
Suzanne Aldington & Louise Ingram, Lonza Biologics plc
Mike Beatrice (ex-FDA), Abbott Laboratories
Paul Bird & Angus Thompson, Fujifilm Diosynth Biotechnologies
Richard Francis, Francis Biopharma
Mairead Looby, Pfizer
Graham McCartney & Matt Osborne, Eli Lilly
Patrick Sheehy, Janssen Biologics
Joanna Ward, Seattle Genetics
Stephen Ward, Stabilitech
Ron Wheeler, Promega
John Woodgate, Pall Life Sciences
A networking dinner will be held on the first evening.
The module costs £1600, with a £100 discount if you register and pay before 14 January.
Download the Flyer
Page last modified on 01 aug 12 14:21
