CLINICAL SUPPLY MANUFACTURING ARTICLES
Challenges In Manufacturing TIL For Clinical Trials
Tumor-infiltrating lymphocyte cell therapy shows promise for treating solid tumors, but its complex manufacturing profile brings a unique set of issues. Here are some things to watch out for.
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.
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.
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
-
![GettyImages-1467240751 patient doctor]( "Delivering Apheresis Treatment From The USA To The UK Within 24 Hours")
The goal was to perform next-day collection of temperature-sensitive tumor material for an urgent patient treatment. A flexible mitigation strategy was essential to manage short turnaround.
-
![GettyImages-820427458 clinical trials]( "Ensure Seamless, Efficient Delivery Of Clinical Trial Materials Worldwide")
Drug discovery companies, CROs, and CDMOs are under pressure to find supply management solutions that ensure delivery of clinical trial materials while navigating complex study designs and the regulatory landscape.
-
![Scientist syringe vaccine GettyImages-1351831059]( "Overcome The Supply Chain Complexities Of Vaccine Development")
Explore the industry impact of rapidly evolving vaccinology, the power of next-gen science and technology, and how finding the right supply chain partner has never been more essential.
-
![cdmo-drug-assembly-manual-GettyImages-1339603591]( "Practical Playbook For The Manual Assembly Of Combination Products")
Manual assembly plays a vital role in early‑phase combination product development. Learn how strong process design, collaboration, and quality controls help teams reduce risk, improve consistency, and move confidently toward later‑stage manufacturing.
-
![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).
-
![West]( "Vial Containment Systems For Gene And Cell Therapies")
CZ vial-stopper-seal combinations offer a viable solution for the challenges associated with low-temperature storage of cell therapy drug products.
-
![Laptop clinical trials iStock-653839742]( "What Are Decentralized Clinical Trials (DCTs)?")
Discover how DCTs leverage “virtual” tools, such as telemedicine, sensory-based technologies, wearable medical devices, and direct delivery of study drugs and materials to patients’ homes.
