CLINICAL SUPPLY MANUFACTURING ARTICLES
Radiopharmaceuticals: Navigating FDA Guidance And CMC Considerations
The unique nature of radiopharmaceuticals necessitates specialized regulatory considerations, particularly for chemistry, manufacturing, and controls (CMC).
CLINICAL SUPPLY MANUFACTURING RESOURCES
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Learn why the ability to get investigational products to sites, and appropriately store them, is not a given – and this oversight can have serious consequences.
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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.
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As innovative, complex therapeutics advance toward clinical trials, properly handling, storing, and packaging temperature-sensitive critical materials is essential to maintain product integrity.
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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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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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Optimize your speed to clinic by securing a development and aseptic fill/finish partner to support your applications with the right manufacturing equipment, communications, and SOPs.
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While cell and gene therapies are bringing new hope to patients experiencing rare and serious diseases, uncover how they're disrupting the biopharma market in new and challenging ways.