CLINICAL SUPPLY MANUFACTURING ARTICLES
When Does GMP Matter In Non-GMP Settings?
Would you ever need to follow GMP standards in workspaces where GMP is not required or possible? This article digs into why, when, and how to follow the principles of GMP.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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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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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.
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Adopt an integrated development strategy to streamline the path from early development to the clinic, ensuring timely clinical supply while reducing delays, risk, and inefficiencies.
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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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Many small and/or early-stage companies are not aware of the need, or the possibility, of finding a CDMO that specializes in meeting their specific requirements.
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For the industry to realize the potential of cell and gene therapies (CGTs), we must develop improved solutions that reliably support the control and transport of critical CGT raw materials and products.
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Review the hurdles that can slow your time to market, including the challenges in packaging high-value therapies and solutions to help you mitigate risk and simplify the journey.