Cell and Gene Logistics

  1. Validation Of Integrated Cryogenic Systems For Point Of Care Cellular Manufacturing 4/13/2021

    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.

  2. Internal Logistics: Exploring The Last 100m 4/13/2021

    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?

  3. Achieving A Flexible, Integrated And Sustainable Cryogenic Cold Chain Ecosystem 4/13/2021

    During this discussion, panelists examine the cell and gene therapy solutions that have been designed to overcome challenges in the cryogenic cold chain ecosystem.

  4. Digitally Connected, Liquid Nitrogen-Free Cryogenic Cold Chain 4/12/2021

    A cryogenic cold chain starts with cryopreservation. Achieve consistent results without liquid nitrogen, scale effectively and efficiently, and get traceable digital records.

  5. Switch To A Nitrogen-Free Cryopreservation System 4/5/2021

    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.

  6. The Science Of Cell Therapy Thawing 4/5/2021

    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.

  7. Process And Communication: Navigating Logistical Complexity In Matched Cellular Therapy Trials 3/10/2021

    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.

  8. Navigating The Adoption Of Continuous Pharma Manufacturing 3/1/2021

    Driving a path forward for continuous manufacturing calls for a closer look at current global challenges, any existing barriers, and the ideas and initiatives necessary to fulfill its potential.

  9. Beyond mRNA Vaccines – Emerging Applications For Lipid Nanoparticle Delivery Technologies 1/19/2021

    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.

  10. Clinical Supply Global Optimization: Managing Complex Global Drug Distribution And Expiry 1/12/2021

    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.