ISSN:
1476-5535
Keywords:
Code of Federal Regulations
;
DNA
;
Factor 8
;
Food and Drug Administration
;
Human immunodeficiency virus
;
Infectious bovine rhinotracheitis virus
;
Monoclonal antibody
;
Polynucleotide
;
Safety test
;
Sindbis virus
Source:
Springer Online Journal Archives 1860-2000
Topics:
Biology
,
Process Engineering, Biotechnology, Nutrition Technology
Notes:
Summary The FDA has set limits concerning the viral and molecular contamination of monoclonal antibody products intended for human use. Industry has an obligation to be as familiar with these limits as it has been with federal requirements pertaining to pyrogens and bacteria. The assessment of risk from polynucleotides, based on molecular biologic and existing technical limitations, is discssed, as is the strategy of validating the purification of monoclonal antibodies of viral contaminants in terms of an indicator organism concept.
Type of Medium:
Electronic Resource
URL:
http://dx.doi.org/10.1007/BF01569522
