The Processing and Formulation Complexities of Therapeutic Biologics Compel Heightened Focus on Excipient Needs

The processing and formulation complexities of the new generation of therapeutic biologics are compelling industry and regulators to take a hard look at the risks and requirements of the raw materials and excipients involved.

Emerging into clear relief is the need for collaboration in standard setting and opening of development pathways to make sure that excipients are available that are fit for purpose in handling these complexities.

The various dimensions of the challenges involved in assessing and assuring excipient fitness for purpose for the new biologics – and the urgency in addressing them – were explored by Biogen Quality Intelligence Associate Director Janeen Skutnik-Wilkinson at a workshop on regulatory, compliance, and bioequivalence excipient issues held at Health Canada (HC) in Ottawa on September 20.

The workshop was co-sponsored by the Canadian Society for Pharmaceutical Sciences (CSPS) and the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas), and included academic participation as well as that of experts from Health Canada and industry.

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