Access to all documents and request for further information are available to all users at no cost. In order to provide you with this free service, William Reed Business Media SAS does share your information with companies that have content on this site. When you access a document or request further information from this site, your information may be shared with the owners of that document or information.
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.