Abstract
Adventitious agents are those that are not inherent in the production of biopharmaceuticals. Microbial adventitious agents, Microbiocidal agents, help for inactivation of viruses, bacteria, fungi, mycoplasma, bacterial spore and sometimes prion. Bovine spongiform encephalopathy (BSE) agents, abnormal prions, are also potential adventitious agents. Adventitious agents can be introduced during establishment of cell lines, cell culture/fermentation, capture and downstream processing steps, formulation/filling, and even during drug delivery Therapeutic biotechnology products must have excellent safety characteristics. However, the potential introduction of adventitious agents must continually be evaluated for safety. The testing procedures that is performed for this purpose is addressed in regulatory documents that include ICH guidelines, European U.S., and Japanese Pharmacopoeia (EP,USP and JP) documents. In some cases, 9 CFR (U.S. Code of Federal Regulations) and 21 CFR, 211 and 610 are also applicable.
Published Version
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