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With no standardized methods in analytical development of cell and gene therapies, we must define our own best practices Looking at the evolution and industrialization of analytical development in biologics over the past 20 years: what did we learn and…
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CMC/Operations disciplines have an important role in the commercialization of powerful new cell therapies Well understood development principles can be applied, though there are challenges It is important to identify when to draw on experience and when to adapt/grow to…
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Discussing the growing regulatory complexity in the world of pharmaceutical manufacturing. How are new guidelines and regulators’ expectations during inspections changing? Taking a process-based approach to impact assessment, and customizing a setup that identifies and acts on signals proactively Bringing…
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What are some of the unique challenges and opportunities in commercializing live modalities like CAR-T? Weighing the pros and cons of centralized versus decentralized production models for these new treatments Discussing how our industry’s quality culture informs these new products…
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Highlighting the scale-up opportunity for dramatic patient benefit through the lens of a patient Outlining the inextricable link between manufacturing and the patient experience for autologous cell therapies Considering the different scaling goals: commercial viability, reliability, patient access, etc. —…
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