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

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

Dr Chika Nweke is an Associate Professor (Education) in the Department of Biochemical Engineering, UCL and is responsible for the Bioprocess Validation and Quality by Design (QbD) undergraduate, MSc and MBI courses. She completed her undergraduate and PhD degrees in the Department of Biochemical Engineering, UCL where her research focused on the mechanical performance of chromatographic adsorbents in collaboration with Eli Lilly & Co., during which time she published a number of papers on the subject. Chika is also the Departmental Tutor, Director for Equality, Diversity and Inclusion (EDI) as well as the Design & Professional Skills lead for the Engineering Faculty Integrated Engineering Programme (IEP).

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