PER.C6® cell lines are extensively characterized human cell lines specifically developed for industrial manufacturing of biopharmaceuticals. PER.C6® cell lines have an unrivalled safety record, built up over a decade of preclinical and clinical studies. These data, together with a full description of the origin and development of the PER.C6® cell lines, are included in an extensive Cell Substrate Biologics Master File lodged with the FDA, the US regulatory agency. The human origin of the cell lines offer a further safety assurance, compared with animal-based biopharmaceutical production platforms. Its consistently high yields make these cell lines ideally suited to the manufacture of biosimilar molecules, such as monoclonal antibodies as well as more complex therapeutic glycoproteins.
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