Quality standards for biopharmaceuticals: the importance of good manufacturing practice

Author(s): Elwyn Griffiths, DSc, PhD

Abstract: Regulatory standards for recombinant DNA (rDNA)-derived medicinal products put in place over 40 years ago provided a framework for moving forward with novel biotechnologies and biosimilars leading to their success as highly eff ective medicines. As biologicals and biosimilars are increasingly developed, licensed and used worldwide less experienced manufacturers and regulatory agencies need support […]

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