PT  - JOURNAL ARTICLE
AU  - Khan, A. S.
TI  - Regulatory Considerations for Raw Materials Used in Biological Products
DP  - 2010 Sep 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 451--457
VI  - 64
IP  - 5
4099  - http://journal.pda.org/content/64/5/451.short
4100  - http://journal.pda.org/content/64/5/451.full
SO  - PDA J Pharm Sci Technol2010 Sep 01; 64
AB  - Raw materials are critical components of product manufacture; these include source materials such as cell substrates, tissues, and biological fluids required for product manufacture, as well as biological materials required for cell growth, propagation, differentiation, and selection. Adventitious viruses are a major safety concern in biological raw materials. This paper discusses the specific concerns related to different types of biological materials and presents the Center for Biologics Evaluation and Research's perspective on the qualification and management of raw materials for purposes of developing a safety program for the manufacture of biological products.