CLINICAL SUPPLY MANUFACTURING ARTICLES
Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why
The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.
CLINICAL SUPPLY MANUFACTURING VIDEOS
Expert speakers discuss current operational obstacles and explore strategic solutions to optimize a supply chain strategy in the years ahead.
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.
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.
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
-
![DD 2 - 2mL_10mL_Vials_Tubs_Capped]( "Safeguarding Cell Therapy Cryopreservation: Primary Containers")
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.
-
![DD 3 - PFS Grouping 002]( "Lifecycle Planning For Containment And Delivery Of Biologics Drug Products")
Read more about trends in the biologics market that could impact the lifecycle strategies for your drug product and steps you can take around drug packaging early in development.
-
![pharma-success-GettyImages-2217587867]( "Why Advanced cGMP Manufacturing Is Key to Pharma Success")
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.
-
![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.
-
![GettyImages-1299873218-lab]( "Expertise, Flexibility In Lipid Nanoparticle Clinical Manufacturing")
Explore the unique capabilities at a Vancouver, Canada site for clinical-scale manufacture of lipid nanoparticles (LNPs).
-
![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.
-
![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.
