INSIGHTS ON CELL & GENE THERAPY LOGISTICS

• Depot-To-Patient Service Overview

  This infographic provides an overview of Fisher Clinical’s depot-to-patient solution to support decentralized clinical trials in the US.

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

  The current implementation of single-use bag technology is reducing operating costs and mitigating the contamination risk of traditional stainless steel freezing tanks and bottles. However, under frozen temperature these single-use components are brittle and prone to failure that can lead to product loss and contamination, especially during transportation. 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.

• 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.

• Factoring The “What Ifs” Into Supply Forecasting

  Growing urgency in the biopharmaceutical industry to speed new products to market is leading to greater appreciation for supply forecasting as a strategic and highly complex success factor. This paper discusses the aspects to consider when developing a supply plan, the influence of early decisions and impact on outcome as a trial progresses, and how decisions can put patients and the trial at risk.

• 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.

• Risk Mitigation For Single-Use Cold Chain Distribution

  In this recorded webinar, we will share risk mitigation study data showing the utility of low temperature suitable materials and packaging, employment of sensors for monitoring shipments, and better qualification and evaluation through simulated standards and real-world transit.

• Ancillary Supplies: Clinical Trial ‘Must-Haves’ That Require Early Planning

  Ancillary supplies are a necessary component in every clinical trial, though these products are often perceived as secondary in importance to investigational medicinal products (IMPs). Janet Williams, senior director, global supply chain management, and Julie Hoffman, senior director of commercial strategy and execution, discuss why ancillaries are as essential as IMPs, and why sponsors should devote as much attention to early planning for ancillary supplies as they do for study drugs.