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Eudralex Volume 3 QUALITY OF BIOTECHNOLOGICAL PRODUCTS: STABILITY TESTING OF BIOTECHNOLOGICAL/ BIOLOGICAL PRODUCTS

Origin/Publisher:

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

Document Type:
Guideline
Content:
The guidance stated in this annex applies to well-characterised proteins and polypeptides,their derivatives and products of which they are components, and which are isolated from tissues, body fluids, cell cultures, or produced using rDNA technology. Thus, the document covers the generation and submission of stability data for products such as cytokines (interferons, interleukins, colony-stimulating factors, tumour necrosis factors),erythropoietins, plasminogen activators, blood plasma factors, growth hormones and growth factors, insulins, monoclonal antibodies, and vaccines consisting of well-characterised proteins or polypeptides.

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