Author Description

This book records the work of an expert committee commissioned to coordinate a range of research & other activities needed to ensure that biological products conform to international standards of purity, potency, safety & stability. The book has two parts. The first opens with a brief discussion of selected issues relevant to the production & quality testing of biologicals, followed by comments on the status & development of international biological standards & reference reagents for various antibiotics, antibodies, antigens, blood products, cytokines & growth factors, & endocrinological substances. These international reference materials are held & distributed by four main international laboratories for use in the standardization & control of biologicals. Brief comments alert readers to newly adopted international standards, newly identified needs for international reference materials, & studies being conducted to identify candidate preparations & assess their suitability to serve as international standards.