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UCL Department of Biochemical Engineering

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Design of Experiments for Bioprocess Optimisation

Learn how experimental design techniques can be used to rapidly understand and optimise bioprocess performance.

This module shows laboratory scientists and engineers how experimental design techniques can be used to rapidly understand and optimise bioprocess performance.

It provides managers with insights on how experimental design and small scale experimental models can underpin Quality by Design (QbD) approaches. Training is focused on the hands on use of DoE software rather than underlying statistics. Bioprocess case studies, supported by a series of introductory and expert lectures will enable you to:

• Generate appropriate experimental designs within fixed research budgets and timescales.
• Ensure analytical methods can be validated and provide reliable data for process evaluation.
• Rapidly screen and optimise different fermentation media and operating conditions.
• Obtain the highest yield of active product throughout your downstream process sequence.
• Understand the relationship between DoE and QbD.
• Network with sector leaders and subject matter experts.

This MBI is recommended for:

The course is designed for all those involved in bioprocess development and optimisation including:

  • Bioprocess applications specialists
  • Hands-on bioprocess scientists and engineers
  • Research managers and consultants
Module Leader

Andrea is a Lecturer in Bioseparations (Downstream Processing). She currently leads the technology-transfer activities of the ultra scale-down technologies from UCL. Her research covers the area of bioseparations including membrane filtration, depth filtration and centrifugation for cell harvests and primary recovery with a focus on the establishment of the next generation ultra scale-down technologies. She applies the “whole bioprocess” approach where she integrates the application of ultra scale-down technologies and cost modelling in bioprocess design. Previously, she worked as a senior consultant on bioprocess and cost modelling projects, capacity planning, and process technology assessments for biopharmaceutical companies. She also has experience in product management and product development. Andrea has a PhD from UCL Biochemical Engineering and MSc in Chemical Engineering and Biochemical Engineering (cum laude) from Delft University of Technology.

Programme Outline

Day 1

  • Introduction to module and design of experiments
  • Introduction to experimental design techniques and software
  • Case studies: analytical method validation (OFAT vs DoE)
  • Case Study: Analytical method development
  • Industrial analytical method validation using DoE

Day 2

  • Screening and optimisation of microbial fermentations
  • Case study: fermentation process screening
  • Case study: fermentation process optimisation and scaleup
  • Protein refolding, stabilisation and formulation: structural and environmental parameters that impact on maintenance and stabilisation of protein structure and activity
  • Development of a Quality by Design (QbD) pharmaceutical production process using sequential DoE methodology

Day 3

  • Case study: primary product recovery by microfiltration
  • The application of factorial design in high throughput scale-down bioprocess development: examples in fermentation and cell culture
  • DoE and the multivariate consequences for bioprocess development
  • Discussion forum