The development of potency assay(s) for biosimilars is based on the understanding of the known mechanism(s) of action of the molecule. This requires the sponsor to establish a functional cell-based bioassay at an early stage of the product development life-cycle and apply the bioassay for biosimilar product release, stability, characterization, and similarity assessment of biosimilar lots and reference product lots. With increasing knowledge of the reference product, requirements from regulatory agencies, and advancement of technology, additional bioassays for manufacturing control may be needed for molecules with multiple mechanisms of action. For molecules with ADCC effector function, a functional or surrogate ADCC assay will likely be required to control ADCC activity in addition to the control of N-linked Fc glycosylation. Considerations and challenges of bioassay development and specification assessment will be discussed in this presentation.
Couse Duration (hh:mm:ss): 01:55:00
Director, U.S. Regulatory Affairs – GlaxoSmithKline
USP Bioassay Validation ad hoc Panel
B.S. em Matemática, Lafayette College
M.A. em Estatística & Pesquisa Operacional, University of Pennsylvania