CLINICAL SUPPLY MANUFACTURING ARTICLES
Strategizing The Scale-Up Of Cell Therapy Manufacturing Capacity
Adaptimmune’s Mike Blankenstein, vice president of patient supply operations, discusses the team's manufacturing network strategy designed to evolve with them as the company grows from clinical to commercial supply needs, balancing cost and risk, while ensuring flexibility to respond to patients’ needs.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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Read more about trends in the biologics market that could impact the lifecycle strategies for your drug product and steps you can take around drug packaging early in development.
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Learn how a top 20 US-based pharma company achieved more capacity to meet commercial supply needs in an accelerated timeline followed by pre-approval inspection with the help of a CMO partner.
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Uncover how a small-sized biotech company was able to resolve critical regulatory CMC deficiencies to meet FDA requirements.
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A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.
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The goal was to perform next-day collection of temperature-sensitive tumor material for an urgent patient treatment. A flexible mitigation strategy was essential to manage short turnaround.
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Learn more about why focusing on packaging solutions early on can keep development on track, help you meet milestones, and get your product to market faster.
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While in their early-stage development of a mAb biosimilar for oncology treatment, a large biopharmaceuticals company sought a packaging recommendation: a stopper to maintain high-quality standards.