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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The Daikyo Crystal Zenith nested vials meet the exterior dimensions of the glass standard ISO 8362-1. The vials maintain CCI for up to 6 months and can withstand ultra-cold temperatures and drop conditions.
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Handling development and manufacturing challenges for orphan drugs requires experience, expertise and scalable technologies, along with a flexible and agile supply chain.
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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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Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.
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Spray drying depends on precise control, scalable methods, and solid quality systems. Strong design and GMP‑aligned execution help reduce risk and move complex compounds forward efficiently.
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Assessing outsourcing partners’ credentials in people, technology, supply chains, and integration will make all the difference as sponsors aim to streamline processes on the path to commercialization.
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Discover how the simplification and digitization of clinical supply chain operations enhanced transparency, lowered risks and expenses, and optimized efficiency.