CLINICAL SUPPLY PACKAGING ARTICLES

The rapid evolution toward flexible, decentralized clinical supply models is placing unprecedented strain on traditional clinical packaging organizations. Can traditional models adapt fast enough to stay viable?
CLINICAL SUPPLY PACKAGING RESOURCES
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Experts explore a project to add a contained manufacturing facility and potent packaging suite by discussing the attention to technical detail required to exceed the required high standards and regulatory controls.
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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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Explore why engaging randomization and trial supply management (RTSM) services early in study startup can help protect clinical trials and expose substantial efficiencies, effectively baking in practices that help streamline supply chains.
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Learn about a biotech company with a recently approved gene therapy product that needed to select a packaging solution to meet their needs for storage at low temperatures and still get to market quickly.
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One of the most significant changes in the new EU regulation is Annex VI, which covers changes in the labelling requirements for investigational medical products (IMPs). So, what are the implications of these changes and how will they affect outer immediate packaging?
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When selecting a supply chain partner, due diligence is critical. This article highlights questions you should be asking to ensure you are selecting the right supply chain partner for your clinical trial needs.
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Examine the robotic technologies poised to increase manufacturing flexibility and efficiency while minimizing risk when bringing biologics to market.