Virological aspects of the quality control of human monoclonal antibodies.
The use of human monoclonal antibodies derived ultimately from lymphocytes raises particular virological concerns. They may be addressed by good documentation of the source materials including the health of the original donor and details of the development of the cell line, and by validation of the production process. All products must be assessed individually depending on their quality and intended use.
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National Institute for Biological Standards and Control, Potters Bar, Herts, UK.
D000911:Antibodies, Monoclonal / Q000302:isolation & purification*; D004340:Drug Contamination / Q000517:prevention & control; D006801:Humans; D006825:Hybridomas / Q000276:immunology / Q000382:microbiology; D011786:Quality Control; D012449:Safety; D014780:Viruses / Q000302:isolation & purification*
D000911:Antibodies, Monoclonal