Overview

This four-day online course provides expert guidance on using a lifecycle approach to bioprocess characterisation and validation which integrates:

• Quality by Design (QbD)
• Design of Experiments (DoE)
• Process Analytical Technology (PAT)

You'll learn about:

• European and U.S. regulations
• performing risk assessments
• combining scale-down models with historical knowledge and DoE to map out design space
• the impact of single-use components on validation needs
• applying QbD to continuous operations and when implementing pre/post-approval process changes

This course is for scientists and engineers working in the biotech sector.

Course content and structure

Teaching will be online, over four consecutive days. You'll be taught in small classes, with an emphasis on interactive problem solving and case studies.

Each day will cover the following topics:

Day 1

• Quality by Design: the enhanced route for process development
• 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 QbD 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
• Workshop: how to perform a tangential flow filtration QbD study
• Workshop: process validation for the production of biotherapeutics based on industrial case studies

Day 4

• Case study: integrating QbD into bioprocess characterisation and validation

Who the course is for

This course is for scientists and engineers working in the biotech sector and involved in:

• process development
• process characterisation
• validation
• manufacturing
• quality
• regulatory activities

Learning outcomes

After completing this course you should be able to:

• understand 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
• perform risk assessments to determine Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs)
• understand the principles behind the characterisation and validation of unit operations, such as fermentation, filtration, chromatography, formulation through to supply chain logistics
• apply QbD to continuous operations, e.g. perfusion culture and filtration operations
• apply QbD when implementing pre/post-approval process changes

Costs and group bookings

The standard price for this course is £1,750.

Special prices are available for groups and SMEs. Contact mbi-training@ucl.ac.uk for more information.

Modular Training for the Bioprocess Industries (MBI)

The award-winning MBI programme is a series of UCL-accredited short courses for people working in the bioprocessing industry. It's designed and delivered in collaboration with over 70 industrial experts.

The programme provides flexible professional development training. You can choose to take standalone courses or combine them for a Certificate, Diploma or Master's qualification. It complements in-house training by providing broader perspectives for more informed decision-making.

Courses have so far been delivered to over 900 individuals from more than 300 companies, 30% of which are non-UK, demonstrating its strong international impact.

MBI plays a central role in the department's knowledge-transfer activities. This ensures that cutting-edge research is undertaken to capture the value of integrating engineering with complex and fast-moving biology, which helps keep the global industry ahead in manufacturing.

Benefits of MBI

By attending an MBI course, you'll:

• benefit from knowledge transfer and upskilling in core bioprocessing fundamentals and trends in industry
• gain a deeper understanding of process options and engineering constraints
• acquire the tools to optimise process performance and economics
• learn about the latest technical and regulatory developments
• have access to cutting edge research methodologies
• network with sector leaders and subject matter experts
• increase your flexibility, motivation, creativity and professional status

Further information

There is more information about the MBI on the Department of Biochemical Engineering's website. If you have questions about fees or how to combine courses for a specific qualification, please email mbi-training@ucl.ac.uk

Course team

Dr Chika Nweke – Module Leader

Chika is an Associate Professor (Education) in the Department of Biochemical Engineering at UCL.

Course information last modified: 22 Jan 2024, 12:44