CERSI P.I. and Collaborator: Sarah Michel, Ph.D.
FDA SMEs and Collaborators: Ashutosh Rao, Ph.D., CDER, Elliot Rosen, MS CDER
Project Overview
Trace metals, such as iron, copper, and zinc, can be found nearly everywhere in varying degrees. In pharmaceutical products, they are found as leachables from the container closure system, the buffer system used, and reactions in their presence can be catalyzed by exposure to light, heat, agitation or freeze/thaw cycles. These metals may damage biotechnology products via fragmentation and aggregation, and should therefore be analyzed as accurately as possible to ensure product quality. Aggregated proteins can trigger immunogenicity and serious adverse events, including death in patients. Trace metals also contribute to biological disease states and have been targets for various therapies. Therefore, we will analyze these metals in products and biological samples and determine their propensity for damage. This data will allow reviewers to better ensure product quality, safety, and efficacy, and contribute to science-based decision-making.
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