Amittha Wickrema, Ph.D., Professor of Medicine, Director, Advanced Cellular Therapeutics Facility, University of Chicago, reviews the cold chain workflow from start to finish for a cellular therapy product.
If advanced therapies are to be scaled, their management at hospital sites has to be scalable. How can we take complexity out — making life easier for couriers, manufacturers and hospitals — and create a seamless supply chain?
This study focuses on the running costs and carbon emissions associated with cryopreservation equipment, comparing a liquid nitrogen (LN2)-free controlled-rate freezer with a typical liquid nitrogen-based system. The environmental implications of using liquid nitrogen for cell freezing are explored along with carbon emissions during the manufacture, transportation, and operation of LN2-free controlled-rate freezers.
This guide summarizes the science of thawing following conventional, slow freezing methods. We address how cell thawing has historically developed into the techniques used today, along with the physical and biological implications of key metrics and components, such as warming rate and ice structure. Also included are reviews of key studies from scientific literature and a consideration of the interactions between cooling and warming rates, as applicable to cell and gene therapies.
Autologous and other matched cellular therapies hold tremendous promise for oncology and other indications, yet the development of these transformational personalized investigational products can be operationally and logistically complex. Read how clear and consistent communication among the sponsor, sites, manufacturing facilities, and the CRO partner helps sponsors and sites mitigate any issues.
The potential of lipid nanoparticle-based drug delivery technologies to enable a new generation of medicines was made clear in 2020 when the first two mRNA vaccines for COVID-19 were rapidly developed and authorized for emergency use. What other applications are now being explored for such delivery technologies? Dr. Jay Natarajan, Director of R&D, competence center for LNP technology, answers questions in this interview.
A global top-ten pharmaceutical company was sponsoring a complex, 8-year Phase III trial across 43 countries. The Sponsor was under intense pressure to reduce trial costs and leverage internal resources. Ultimately, study sites began to run out of medication. They realized that the trial could be better managed if it was outsourced.