Eudralex Volume 3 CONCEPT PAPER ON THE NEED TO REVISE THE GUIDELINE ON THE USE OF TRANSGENIC ANIMALS IN THE MANUFACTURE OF BIOLOGICAL MEDICINAL PRODUCTS FOR HUMAN USE (3AB7A OF JULY 1995)
Title:
Eudralex Volume 3 CONCEPT PAPER ON THE NEED TO REVISE THE GUIDELINE ON THE USE OF
TRANSGENIC ANIMALS IN THE MANUFACTURE OF BIOLOGICAL MEDICINAL
PRODUCTS FOR HUMAN USE (3AB7A OF JULY 1995)
Origin/Publisher:
European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/
Document Type:
Note for Guidance
Content:
This document is concerned with the use of transgenic animals to produce biological pharmaceutical materials for use in human recipients. Transgenic animals may produce
higher quantities of material in more concentrated form than existing culture methods, and therefore have considerable advantages in both the cost of producing the starting material and in its downstream processing.