Cell Therapy Manufacturing: Getting it Right From the Start

1-3 March 2016
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Delivered at Cell Therapy Catapult, Guy’s Hospital, London & UCL


Cell and gene therapy have emerged as two of the most significant therapeutic modalities of the 21st century. Both independently and in combination (genetically modified cells), these technologies are starting to produce transformative therapies for patients across a broad range of medical fields including cancer immunotherapy and regenerative medicine. The
need for scalable cost-effective manufacturing is a key requirement for the field.

The course objective is to challenge delegates to think about the commercial product, market, and process from the outset and to use that information to inform the process development and manufacturing strategy for clinical trials and routine manufacture. This will be achieved through lectures from a wide range of experienced, successful, international industrialists building on a solid framework of regulatory requirements. The experience gained will be put to use in developing case study processes and understanding how these processes relate to cost of goods models and what factors most impact the cost of goods.

A final presentation to the panel of international industrialists with feedback will round off the training course experience.

Who should attend?

Stakeholders in the cell and gene therapy sector who need to understand the manufacturing challenges and/or are planning or progressing a therapy through the R&D and translation phases and into routine clinical practice and commercialization. The course comprehensively covers both the service (autologous) and universal (allogeneic) approaches to whole bioprocessing.

Previous company delegates include; GE Healthcare, GlaxoSmithKline, Johnson & Johnson, Medical Research Council, Plasticell, ReNeuron, Sanofi, Smith & Nephew and UCL Hospitals.

Programme

Day 1
• Course overview
• Introduction to the cell and gene therapy industry
• Cell and gene therapy platforms
• Progress and challenges in manufacturing
• Process development
• Cell therapy catapult lab tour

Day 2
• End-to-end supply chain
• Cell therapy manufacturing
• Cost of goods
• Commercial case study
• Storage and distribution

Day 3
• ATMP regulatory pathway
• Overview of clinical landscape
• Gene therapy manufacturing
• Commercial case study
• Manufacturing ecosystem

Module Leaders

Prof Chris Mason, UCL
Prof Suzy Farid, UCL
Dr Farlan Veraitch, UCL
Dr Ivan Wall, UCL
Dr Stephen Wall, Cell Therapy Catapult
Dr Angela Osborne, amc

Industrial Expert Speakers Include

EMA
Intercytex
Moorfields Eye Hospital
NHSBT
Organogenesis
Pluristem
ReNeuron
Royal Free Hospital

A networking dinner will be held on the first evening.

For further information and bookings please contact:
E: mbi-training@ucl.ac.uk
T: +44 (0) 20 7679 9619 l +44 (0) 203 549 5619

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