NR AAKU
AU anonym
TI Safety of biological products prepared from mammalian cell culture. Bovine spongiform encephalopathy and other non-viral transmissible agents.
QU Developments in Biological Standardization 1998; 93: 133-4, Symposium organized and sponsored by the Marcel-Mérieux Foundation and the International Association of Biological Standardization, Veyrier-du-Lac, Annecy, September-October 1996
PT journal article; review; review, tutorial
AB
This volume reflects the proceedings of the WHO Consultation on the Safety of Biological Products Prepared from Mammalian Cell Substrates, and forms the basis upon which the revised WHO requirements were formulated and accepted by the 1996 Expert Committee on Biological Standardization (ECBS).
Primary cells, diploid cells, and continuous cell lines (CCLs) are considered both in terms of potential risks and as appropriate methods to reduce and control those risks during the manufacturing process. Also discussed is the past clinical experience with products derived from these three types of cell substrates.
Bringing together contributions by international experts in the field, this volume is important reading for cell and molecular biologists, and all those concerned with the development and manufacture of biological products.
ZR 0
MH Animal; Biological Products/*standards; Blood Donors; Cattle; Cells, Cultured; Creutzfeldt-Jakob Syndrome/transmission/virology; Drug Contamination; Electrophoresis, Gel, Two-Dimensional; Encephalopathy, Bovine Spongiform/*transmission/virology; Human; *Technology, Pharmaceutical
SP englisch
PO Schweiz