An Introduction to Downstream Processing for Viral Vector Manufacturing

This two-day course will cover the essential biology of viral vectors and an overview of the key steps in the downstream manufacturing of viral vectors, focusing primarily on AAV and Lentivirus. It will also offer an insight into the regulatory expectations of viral vector manufacturing plus current manufacturing trends and challenges.​

Learning objectives:​

• Be able to describe the development of viral vectors and their use for research and therapeutic applications.​
• Appreciate the importance of viral vector critical quality attributes and their relationship with critical material attributes and critical process parameters.​
• Explore the range of manufacturing procedures employed during the downstream manufacture of viral vector products including clarification, tangential flow filtration, chromatography, sterile filter integrity testing and considerations for aseptic-manifold design, set-up and operation.​
• Recognise and utilise appropriate strategies to address the challenges of manufacturing viral vectors within a GMP environment.​
• Be aware of developments in downstream manufacturing operations to enhance process efficiency and product quality.

Who should attend:

This course is suitable for advanced therapy scientists working in manufacturing operations and process development, technology suppliers and anyone else who wishes to learn about the principles of viral vector manufacture and the techniques employed throughout the downstream workflow.

Course contributors:

The Skills and Training Laboratories would like to thank the following organisations for their invaluable support in the design and delivery of this course - Cytiva, National Horizons Centre and BPES.