CLINICAL SUPPLY MANUFACTURING ARTICLES
Process Mapping For More Effective Knowledge Management
It takes a patchwork of knowledge from multiple complementary mapping tools to generate the process knowledge needed for success in pharmaceutical and biologics manufacturing.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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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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Drug discovery companies, CROs, and CDMOs are under pressure to find supply management solutions that ensure delivery of clinical trial materials while navigating complex study designs and the regulatory landscape.
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Examine the robotic technologies poised to increase manufacturing flexibility and efficiency while minimizing risk when bringing biologics to market.
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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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Learn how this biopharmaceutical research sponsor was able to centralize and digitalize the processes involved in clinical supply production through distribution using GxP Inventory.
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Handling controlled substances presents layers of complexity. Partnering with an experienced CDMO is essential for managing scheduled materials during clinical studies.
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When it comes to transporting highly sensitive and valuable materials, such as cell therapies, learn how teams can ensure that unique storage and distribution requirements are met.