Chimeric Antigen Receptor (CAR) T cell therapy has recently come into the spotlight
due to impressive results in patients with hematological B cell malignancies. Whilst
it is a paradigm shift in personalized medicine, a key unresolved issue is a large
scale manufacturing. Different commercialization models have been developed, however
the price of therapies is likely to remain high until sufficient scale is broadly
available. My thesis examines in detail the manufacturing scale up options for both
clinical trials and commercial supply and the inherent issues of regulatory environment
and quality assurance. The central tenant of this thesis is to assess a point of care
manufacturing option within a hospital or affiliated academic institution, where CARs
are produced by GMP accredited labs. Establishing, whether current GMP qualified labs
are able to service the needs of the community in providing CARs at the point of care.
This will enable a sustainable and scalable solution that is not dependent on one
company and allows the use of increasing numbers of new therapies from innovators.
Driving the costs down as manufacturing, quality assurance, and complex logistics
would not be included in the cost of overall therapy (Table I, Table II).
Table ISummary of four hypothesis questions per country analyzed.
| Country | Manufacturing | Capacity | QA | Personnel | ATMPs simultaneously |
|---|---|---|---|---|---|
| UK | 8 | 95% | 8 | 340 | 36 |
| GER | 7 | 88% | 7 | 129 | 34 |
| CH | 1 | 16% | 1 | 12 | 1 |
| ITA | 2 | 41% | 2 | 19 | 3 |
| ESP | 2 | 26% | 2 | 13 | 4 |
| FRA | 0 | 0% | 0 | NA | 0 |
| NL | 2 | 132% | 2 | 16 | 9 |
| BEL | 1 | 35% | 1 | 23 | 3 |
| SWE | 2 | 194% | 2 | 18 | 11 |
| TUR | 1 | 37% | 1 | UNK | 5 |
| SLO | 0 | 0% | 0 | NA | D |
| NOR | 1 | 218% | 1 | 7 | 8 |
| AUS | 0 | 0 | 0 | NA | 0 |
| Total | 27 | 27 | 579 | 114 | |
| Average | 21 | 4 |
Table IICapacity from 27 labs which met manufacturing capability, represented by 13 EU countries, in comparison
to European Union 27 members of state countries and Europe overall.
| Capacity | % |
|---|---|
| 13 Thesis countries | 46 |
| EU (27) members of state | 32 |
| Europe overall | 25 |
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