Pharmaceutical Technology Europe - April 2010 - (Page 14)

Overcoming manufacturing and financial challenges of personalised cell therapies Person-specific cell therapy could potentially offer a cure as opposed to ongoing treatment, but it is also a disruptive technology that doesn’t currently fit into traditional therapeutic manufacturing processes. There’s already a lot happening on a small scale; however, there’s not much happening on the process development side and there isn’t a lot of manufacturing capacity. This is a particular issue for personalised therapies because one batch is one process for one patient, which means that the research scale is the same as the production scale; however, manufacturing processes are not the same as research processes. There is also the issue of clinical trials, which are very expensive and difficult to obtain funding for. There is also the question of whether the traditional trial structure is suitable for personalised cell therapies. Manufacturing equipment and facilities At the moment, manufacturing equipment technology for cell therapies is very expensive: the disposables are very expensive, the reagents are very expensive and the equipment is expensive, but this partly reflects the clever technology that has gone into their development. For example, when developing T-cell therapies, the initial purification can be done completely manually using a centrifuge to separate the white blood cells from everything else; however, another option is to use a Cobe 2991 cell processor (Gambro, Sweden), which can handle larger volumes. Unfortunately, this system is expensive and, as with many other equipment involved in this space, requires a lot of aseptic operations to put it together. It is also not a closed system. The standard facility for cell therapy manufacturing is currently a grade A/B environment where only one therapy can be worked on per room. The next generation of facilities, however, would include grade D rooms with isolators for aseptic manipulation. This would enable a much higher throughput. Ultimately, it would be beneficial to use facilities that are fully automated where thousands of therapies can be run simultaneously. Ideally, we would like to get to closed robust systems, grade D rooms that can accommodate many therapies, a large number of vendors with validated manufacturing equipment, readily available GMP reagents and GMP operators. Achieving this is a bioprocessing challenge, but it is not impossible. PTE The ideal scenario In summary, cell therapy manufacture currently involves manual processes, a lot of aseptic connections, grade A/ B rooms, a small number of vendors selling highly specialised equipment, and high costs for reagents and consumables. Much of the work is also currently being conducted by researchers. Based on a contribution by Dr Angela Osborne of eXmoor pharma concepts Ltd. To read the full version of this article, go to www.pharmtech.com/osborne www.exmoorpharma.com 1 CONTENTS 9 THE HUMAN GENOME 2 INTRODUCTION 11 CANCER THERAPY UPDATE 5 MORE THAN SCIENCE NEEDED 14 MANUFACTURING CHALLENGES 7 FUTURE SNP MARKET 16 TOP TECHNOLOGIES http://www.pharmtech.com/osborne http://www.exmoorpharma.com

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - April 2010

Pharmaceutical Technology Europe - April 2010
Table of Contents
Why Personalised Medicine Business Models will Require Long-Term Strategies and Great Flexibility in Order to be Successful
Science Alone Will Not Lead to Better Medicines
The Current and Future Market for SNPs
The Hype, Hope and Reality of Pharmacogenetic Tests
Unraveling the Human Genome
Progress in Molecular Diagnostics
Personalising Cancer Therapy
T Cells for Patient-Specific Cancer Treatments
Future Research Strategies for Glucocorticoid Therapy
Overcoming Manufacturing and Financial Challenges of Personalised Cell Therapies
Public-Private Partnerships Prosper
Eight Latest Technologies Showcased

Pharmaceutical Technology Europe - April 2010