INSIGHTS ON CELL & GENE THERAPY LOGISTICS

• Chronicle Software: Scaling For Needs In Cell Therapy

  Get support for your team through visibility of process data, locally and across your manufacturing sites. Obtain greater oversight of day-to-day operations, receive text and email-alerts of equipment alarms, and produce electronic batch records.

• RoSS. Robust Storage And Shipping For All Single Use Bags

  Liquid bulk drug substance is of utmost value after manufacturing from Biopharma industries. The single use bag independent platform RoSS helps to avoid product loss through breakages through robust composition and makes it possible to introduce your flexible end-to-end solution in drug substance logistics.

• Validation Of Integrated Cryogenic Systems For Point Of Care Cellular Manufacturing

  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.

• Internal Logistics: Exploring The Last 100m

  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?

• Achieving A Flexible, Integrated And Sustainable Cryogenic Cold Chain Ecosystem

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

• Digitally Connected, Liquid Nitrogen-Free Cryogenic Cold Chain

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

• Switch To A Nitrogen-Free Cryopreservation System

  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.

• The Science Of Cell Therapy Thawing

  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.

• Process And Communication: Navigating Logistical Complexity In Matched Cellular Therapy Trials

  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.

• Navigating The Adoption Of Continuous Pharma Manufacturing

  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.