CLINICAL SUPPLY MANUFACTURING ARTICLES
The Holistic Guide To Supply Chain For Cell & Gene Therapy Startups
How does the cell and gene therapy supply chain team stay ahead of the expected changes and respond at the speed the developing program expects? Supplier selection, raw materials, built-in quality, warehousing and logistics, and traceability are all covered in this article.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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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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Choosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.
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As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.
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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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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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Advanced cGMP facilities deliver control, expertise, and reliable processes that protect quality and support smooth progress to market. Strong partnerships help reduce risk in complex programs.