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W103d
Establishing Patient-centric Quality Standards: Cell & Gene Therapy Case Studies
Date
May 13, 2020
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The purpose of the CMC Strategy Forum Europe 2020 is to offer a blend of topics that characterize the challenges facing the biotechnology industry in the next decade…
Patient-centric quality standards are a key component of ensuring patient access to safe and efficacious cell and gene therapies. Two case studies relevant to ex vivo autologous T cell therapeutics will be presented, together highlighting how the identification of product-relevant attributes and understanding of clinical exposure range can factor into product specification setting.
Speaker
GlaxoSmithKline
Tracks
