UCL Department of Biochemical Engineering


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

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.

This MBI is recommended for:

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.

Module Leaders

Professor Ajoy Velayudhan is Professor of Bioprocess Engineering and Biotechnology in the Department of Biochemical Engineering at UCL. He is also one of the first cadre of recipients of the EPSRC Manufacturing Fellowships. He has spent ten years in the biotechnology industry in the USA, including periods at Johnson & Johnson, and Bristol-Myers Squibb, where he led process development (R&D) groups in cell culture, downstream processing, and formulations and freeze-drying. His research interests include experimental, computational and theoretical approaches to developing integrated and robust mathematical models for the entire bioprocesses (from cell culture through downstream processing to fill and finish) required to make modern and future biologics medicines. Other research areas include the principled development of models for cellular therapies and other systems in regenerative medicine, and the use of molecular dynamics to isolate important mechanisms in a variety of areas, including the development of tailored excipients as protein formulations.

Ron Wheeler is currently Vice President QA/RA at Promega Corporation, He has 25+ years in Medical Device and Pharmaceutical Industry with focused expertise in Quality Assurance, Process Engineering, and Process Development that fall under the regulatory guidelines of 21 CFR 210, 211, part 11, 820 and ISO 13485:2003. Overall Quality Systems expertise with focus in the following areas: Equipment, Facility and Utilities, Design and installation, Validation, Quality System Improvements and Cost Reduction Initiatives. Interface with FDA and ISO Inspectors, Oversight of Audit Readiness and Responses

Programme Outline

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 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
  • 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

  • FDA Inspection Workshop
  • 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

Day 4

  • Case study: Integrating QbD into Bioprocess Characterisation and Validation