INSIGHTS ON PHARMA LOGISTICS

• Considerations For Your First Clinical Trial

  For a small and emerging biopharma, moving into the clinical trial phase of development can be overwhelming. Tt is important to understand that CROs do not typically manage the comprehensive clinical trial supply chain. This paper reviews seven ‘clinical trial supply best practices’ to help ensure a successful trial.

• 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.

• Taking Digital Control Of Cell Therapy Logistics: An Advanced Therapy Treatment Centre Network Case Study

  Within the manufacturing workflow there are two critical logistics steps 1) transport of the starting material to the manufacturing site and 2) return of the finished product to the treatment center. In this case study we describe work to establish and test a cryogenic logistics pathway for an allogeneic Advanced Therapy Medicinal Product (ATMP).

• A Modern Take On Cell Therapy Logistics

  It wasn’t Paris in Spring, but the annual meeting of the International Society of Cellular Therapy (ISCT) 2020 did happen in May, albeit virtually. From the comfort of their home office with snacks at the ready, attendees devoured sessions on some key topics of the day through a cool digital interface replete with avatars. Here are my highlights on a 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.

• Innovative Strategies To Maintain Product Integrity In Biologic & Biosimilar Clinical Studies

  Delays encountered during clinical studies can have a serious impact on competitive advantage, speed to market and the availability of lower-cost alternatives for patients. Specialized expertise in cold chain shipping and logistics are critical to avoid costly delays and potential for patient harm resulting from an interruption or delay in necessary clinical supply. Maintaining product integrity and reliability of supply can be especially challenging for biologic and biosimilar studies which will almost certainly require cold chain handling.

• How To Select the Best Courier Around The Globe

  As a leading biotechnology company's pipeline and global presence continued to grow, management of the supply chain presented challenges. Additionally, cost pressures demanded a tighter supply chain with better control over inventory levels, and there was a need for increased temperature monitoring of clinical supplies in transit. Learn how data-driven decisions allowed them to realize cost & performance improvements across the supply chain.