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 VIDEOS
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
Industry experts share insights to help you mitigate supply chain risk and accelerate access to novel cell and gene therapies.
Tony Sampognaro, Director, CMC Project Management, Stoke Therapeutics, recalls a rather harrowing experience involving a CMO and Clinical Operations failure to communicate.
Early planning mitigates risk by avoiding stock outs and study delays, minimizing waste with optimized inventory, and forecasting demand to facilitate robust supply planning.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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![GettyImages-1002000796-lab-research-scientist-development]( "Functional Testing Summary Of Daikyo Crystal Zenith Nested Vials")
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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![GettyImages-155372946-cold-chain-cryopreservation-logistics]( "Optimizing Cell Therapy Supply Chains For Success")
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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![small-mole-cdmo-GettyImages-1465073057]( "Breaking Down Early Small Molecule Development")
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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![GettyImages-836663414 medical team meeting]( "Sponsor Overcomes Hold And Steers Products Through Development")
Uncover how a small-sized biotech company was able to resolve critical regulatory CMC deficiencies to meet FDA requirements.
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![Pharmaceutical-Drug-Manufacturing-GettyImages-1405788565]( "Specializing In Small And Early-Stage Partners, Not Just Small Batches")
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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![iStock-1213895723-cold chain-packaging-logistics-storage]( "Overcoming Cell Therapy Supply Chain Challenges")
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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![GettyImages-1368429013-vial]( "Overcoming Challenges In Cell And Gene Therapy Containment")
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.
