CLINICAL SUPPLY MANUFACTURING ARTICLES
Green Gains In Biopharma Without Closing Facilities?
Going green is virtually impossible for biopharma companies with legacy systems, but going greener might be within reach. Here are some ideas to get started.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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CZ vial-stopper-seal combinations offer a viable solution for the challenges associated with low-temperature storage of cell therapy drug products.
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Review different aspects of container selection from the perspective of cryopreservation that are may be overlooked but critical for the quality of cell therapy drug products.
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Learn why clinical labeling, clinical supply chain management, and storage and distribution of clinical trial materials received the most votes in a survey of 100 sponsors outsourcing clinical logistics.
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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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Early‑phase combination products rely on manual assembly. Clear process design, quality controls, and collaboration help clinical supply teams reduce risk and maintain trial‑ready flexibility.
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Obtaining information and proactively mapping out your fill/finish strategy early can de-risk an investment in equipment or processes, ensuring you meet your long-term needs.