CLINICAL SUPPLY MANUFACTURING ARTICLES
Scaling RNA Production From The Lab To The Clinic
Nutcracker's unique approach to scaling up to clinical manufacturing — which brings unique challenges compared to traditional biologics — relies on microfluidics.
CLINICAL SUPPLY MANUFACTURING VIDEOS
Susan Dexter, Chief Technical Officer, Sonnet BioTherapeutics, describes the good choices she made, and one not-so-good choice, in trying to untie a knotted supply chain.
Early planning mitigates risk by avoiding stock outs and study delays, minimizing waste with optimized inventory, and forecasting demand to facilitate robust supply planning.
Tony Sampognaro, Director, CMC Project Management, Stoke Therapeutics, recalls a rather harrowing experience involving a CMO and Clinical Operations failure to communicate.
Christina Yi, Chief Operating Officer at Vaxxinity, vaccine commecialization expert Kimberly Murphy, and Valneva Chief Medical Officer Dr. Juan Carlos Jaramillo discuss the biggest manufacturing challenges they face as they work quickly to develop clinical supply of next-generation vaccines and commercial supply of existing product. The supply chain proves chief among those challenges. In this segment of our recent BioProcess Online Live! event Manufacturing Vaccines On COVID's Coattails, the two discuss how these challenges have impacted timelines, how they're solving those challenges at Vaxxinity and Valneva, and lessons learned during the COVID-19 pandemic that they'll carry into the future.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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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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![West_CZ Insert Needle 115860aw 11569_RGB_2]( "A Practical Packaging Components Checklist For Emerging Biotechs")
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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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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![WEST-ELAS LYO Lyotec-012 LREZ]( "Key Considerations For Selecting Fill/Finish Manufacturing Technologies")
Obtaining information and proactively mapping out your fill/finish strategy early can de-risk an investment in equipment or processes, ensuring you meet your long-term needs.
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![Singota]( "Faster From Formulation To Fill/Finish")
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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![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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![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.
