ABSTRACT
Adventitious agents are those that are not inherent in the production of biopharmaceuticals. Microbial adventitious agents include viruses, bacteria, fungi, and mycoplasma. Transmissible spongiform encephalopathy (TSE) agents are also potential adventitious agents. Raw materials may contain 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 have an excellent safety record. However, the potential introduction of adventitious agents must continually be evaluated. The testing that is performed for this purpose is addressed in regulatory documents that include ICH guidelines, U.S. Points to Consider, and 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 applicable. Table 5.1 lists some of the regulatory documents that describe testing requirements.
