Eudralex Volume 3 GUIDELINE ON POTENCY TESTING OF CELL BASED IMMUNOTHERAPY MEDICINAL PRODUCTS FOR THE TREATMENT OF CANCER

Title:
Eudralex Volume 3 GUIDELINE ON POTENCY TESTING OF CELL BASED IMMUNOTHERAPY MEDICINAL PRODUCTS FOR THE TREATMENT OF CANCER

https://www.gmp-compliance.org/files/guidemgr/guideline-potency-testing-cell-based-immunotherapy-medicinal-products-treatment-cancer-revision-1_en.pdf

Origin/Publisher:

European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/

Document Type:
CHMP Guideline
Content:
This guidance document covers viable cell products for cancer-immunotherapy from autologous or allogeneic origin, consisting of e.g. whole tumour cells or autologous dendritic cells loaded with tumour antigens, all intended to induce tumour-specific cytotoxity although the immunological pathway may differ between products.

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