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Quality by Design for Effective Bioprocess Characterisation and Validation

Quality by Design

Get expert guidance on choosing on how best to integrate QbD, DoE and PAT into lifecycle approach to process characterisation

26 February - 1 March 2018

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.
• Network with sector leaders and subject matter experts.

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.

Programme

Day 1
• Quality by Design – concepts and application for the biotech industry
• PAT challenges for bioprocessing
• QbD: current industry practices and regulatory expectations
• The Roche Genentech QbD approach
• Workshop: comprehensive QbD efforts for a new product

Day 2
• 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 quality by design 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?

Day 3
• Workshop: FDA inspection role play
• Application of QbD to tangential flow filtration processes
• Ultra scale-down tools linked to process modelling for QbD
• QbD applied to cell therapies
• Workshop How to perform a tangential flow filtration QbD study
• Workshop: Process Validation for the Production of Biotherapeutics: Case Studies

Day 4
• Case study: integrating QbD into bioprocess characterisation and validation

UCL Experts

Prof Suzanne Farid - Module Leader

Previous Expert Speakers Include

Richard Francis, Francis Biopharma - Module Leader
Suzanne Aldington, Lonza Biologics
Paul Bird, Fujifilm Diosynth Biotechnologies
Kieth Chidwick, Parexel (Ex-MHRA)
Ronan Hayes, Janssen Biologics
Gregor Kalinowski, Pall Life Sciences
Mairead Looby, Bristol-Myers Squibb
Graham McCartney, Eli Lilly
Ryan McCoy, Cell and Gene Therapy Catapult
Stefanie Menrad, Roche
Andrea Rayat, UCL
Patrick Sheehy, Janssen Biologics
Angus Thompson, Fujifilm Diosynth Biotechnologies
Ron Wheeler, Promega

A networking dinner will be held on the first evening.
For further information and bookings please contact:
E: mbi-training@ucl.ac.uk
T: +44 (0) 20 7679 9619 l +44 (0) 203 549 5619

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