Regulatory authorities (US FDA and the EMEA) impose stringent limits on the amount of microbial contaminates and impurities present during the manufacturing of biological medicines and vaccines.
One area of concern is that the cell substrates used in the production of biopharmaceutical agents may be infected with endogenous viruses or the cell substrates may become contaminated with adventitious microbes during the manufacturing process, such as viruses, bacteria, or Mycoplasma. This paper outlines current strategies to detect these potential contaminants during the production process.
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