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Immune effector cells: survey on proposed interim Standards - Open

posted 14 Oct 2016, 06:21 by Eoin McGrath   [ updated 17 Nov 2016, 01:09 ]
JACIE has opened a public consultation on proposed interim standards to cover the administration of immune receptor cells. The proposed standards originated with FACT earlier in 2016 where centres in the USA are increasingly handling these types of therapies. In Europe, provision of these therapies is still in very early stages but more activity in this area is being observed and we consider that this is a good opportunity to anticipate future demand.

The interim standards are intended to promote quality in administration of immune effector cell products, such as chimeric antigen receptor T cells (CAR-T cells), natural killer cells, virus-specific T cells, therapeutic cellular vaccines, and others. The proposed requirements primarily highlight unique aspects of administration and toxicities of immune effector cells.

Production of these cells is not contemplated in these standards.

The interim standards would be added to the 6th edition and come into effect from 2017 being applicable only to centres administering such therapies. Where they are not being provided, these standards would be considered non-applicable.

The deadline is 11 November 2016.


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Eoin McGrath,
17 Oct 2016, 06:19
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Eoin McGrath,
17 Oct 2016, 06:18
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Eoin McGrath,
17 Oct 2016, 06:19