INSIGHTS ON MANUFACTURING LOGISTICS

• How a Best-Practice Strategy For Sourcing Ancillary Materials Reduced Risk, Spending and Workload In A Global Diabetes Trial

  It’s impossible to run a global clinical trial of an investigational diabetes drug without ancillary materials. And as one leading multi-national pharmaceutical company recently learned, managing ancillaries can be a challenge every bit as complex as the trial itself.

• Delivering Clinical Trial Medications Direct-To-Patient

  In a perfect world patients enrolled in clinical trials would live a short distance from the investigator site where they receive their treatment. Unfortunately that is not always the case. In recent years the Direct-to- Patient model, which brings medical procedures to a patient’s home, has emerged as a solution for Sponsors to increase patient recruitment and retention in clinical trials.

• Low Risk Frozen Distribution Of Single-Use Bags For Bioprocessing

  This paper will discuss the results of applying an approach using sensors and more suitable material to a frozen shipping study of single-use fluoropolymer bags.

• Save Space With Single-Use Bags, Secondary Packaging Solution

  Find out how a multinational biopharma company overcame a diminished shipping capacity challenge after switching to single-use bags to improve storage capacity at one of its production sites.

• What Your CMO Needs To Know About Serialization And Aggregation

  In recent years, the global pharmaceutical industry has been under intense pressure to enhance the safety, security, and continuity of the supply chain. This has required drug manufacturers and a vast range of supply chain partners to work collaboratively to improve supply chain transparency. The goal is to be able to track, trace, and authenticate products, and to assure prescription drug supply from the manufacturer to the patient. Partnering with a CMO that has applied traceability, serialization and aggregation standards across its own operations promises business continuity and speed-to-market that translate to a competitive advantage.

• VIA Capsule System ‒ Liquid Nitrogen-Free Shipping For Cell Therapy Logistics

  Realize a more controlled, assured and patient focused way of shipping cell and gene therapies with the VIA Capsule™ solution. Easily charge this liquid nitrogen-free system using electricity. Securely load the cell therapy using your defined process, and capture records digitally. Integrate activities across the manufacturer, courier, and clinic while maintaining an electronic record of the shipment conditions, location, chain of custody and identity. If needed, use the shipper for temporary cryogenic storage. When the patient is ready, wheel the shipper in.

• Cell Therapy Logistics: Advanced Therapy Treatment Case Study

  This case study describes work the establishment and testing of a cryogenic logistics pathway for an allogeneic Advanced Therapy Medicinal Product (ATMP).

• A Modern Take On Cell Therapy Logistics

  Here are my highlights on an International Society of Cellular Therapy (ISCT) 2020 session that introduced a new way to ship and transport cellular materials, putting patients front and center.

• Key Considerations For Cryogenic Preservation And T Cell Viability

  Illustrating how mammalian cells change when frozen, we offer cryopreservation strategies and identify temperatures at which it's safe to stop controlled cooling and transfer drug product to cryogenic storage.