Focusing on the acquisition of new skills to take discoveries from the lab to the clinic.
Cell and Gene Therapy is fast becoming an established field that aims to utilize the power of cell-based medicines to deliver new therapies for the 21st Century. However, translating the discovery science into manufacturable products has so far been challenging and so multi-disciplinary engineers who possess unique skills are urgently needed to address the manufacture of these complex medicinal products.
This course addresses the real-world challenges of translating discoveries to the clinic in a way that is commercially viable. A series of lectures and interactive case studies will enable you to:
- Understand the distinctions of manufacturing cells compared with biologics
- Understand the challenges faced in advancing cell and gene therapies to clinic and the lessons learned from established companies
- Understand the impact of design and engineering considerations on cell and gene therapy manufacture
- Identify and define critical process parameters for different cell and gene therapy applications
- Knowledge and application of analytical toolsets for quality measurement
- Understand key implications to facilitate and expedite translation from laboratory to a manufacturing and clinical setting
This MBI course is recommended for:
This course is intended for engineers, life scientists and clinicians working in the fields of regenerative medicine, cell and gene therapy, who want to understand how to address translation. The course will also provide a strong fundamental base for life scientists and engineers from biopharma who wish to re-purpose skills for the cell and gene therapy sector.
Key Topics Include
Emphasis is on teaching through interactive problem solving case studies in small classes for effective learning.
- Challenges for scaling up lentivirus
- Taking cell and gene products from lab to clinic in the real world
- Process considerations for universal versus personalised therapies
- Analytics and monitoring where the cell is the product
- A role for automation
- Navigating the critical path to clinic
- Addressing process economics and CoGs
- Case Study: Process and product analytic tools
- Module Leader
Dr Qasim Rafiq is an Associate Professor at University College London in Cell and Gene Therapy Bioprocessing. He is a multidisciplinary engineer working at the life science, engineering and commercial interfaces and his research focuses on the bioprocessing, automation and biomanufacture of cell and gene-based therapies. Prior to joining UCL, he was an Assistant Professor at Aston University where he established the Bioprocess Engineering Group. He completed his PhD at Loughborough University investigating the scalable manufacture of human mesenchymal stem cells in bioreactors.
He has specific interest in addressing the large-scale manufacturing challenges and enhancing process and product understanding to enable successful translation from the laboratory to the clinic. He is both a Chartered Engineer (CEng) and Chartered Scientist (CSci) and sits on multiple scientific and engineering committees including ESACT-UK, the IChemE Biochemical Engineering Subject Interest Group and The BIA’s Cell and Gene Therapy Advisory Committee.
- Participant Feedback
'Overall the course was interesting, and very engaging - this is the best online training course I have been to within this industry. Qasim is an excellent host, all the speakers were very knowledgeable, great questions were asked and answered in detail and generally to the point.' Bioprocess Scientist, eXmoor Pharma
'Very good being interactive - I found the Q&A sessions and panel discussions really engaging and gave great additional depth to the talks.' Scientist, Allergan Biologics
'I thought the course brought a very diverse perspective. It touched nicely on different areas like manufacturing challenges, regulation, economics, and therapeutic areas. As a newcomer to the field this was extremely useful to get this broader overview. Given the current situation the online version was extremely well managed. I particularly liked the sessions on bio-processing (LV, AAV and CAR-T) and would definitely consider other MBI courses following this experience.’ Senior Site Manager, Roche
'This course provided me a broad overview of the Cell and Gene Therapy field, highlighting the importance of my professional role. The manufacturing and commercialization aspects learned will help me incorporate that thinking rationale into the early process development work I am conducting.' Bioprocess Engineer, Exothera
'I really enjoyed it. I loved the quality of the presentations, thought the speaker were all very knowledgeable and appreciated the opportunity to ask questions live.' Bioprocess Engineer, eXmoor Pharma