The ultimate success of gene and cell therapy products relies on the seamless delivery of a potent drug product to patients. The pharmaceutical supply chain is inherently complex; however, gene therapies face additional roadblocks such as ever-changing regulatory compliance, chain of custody due to the personalized nature of autologous therapies, patient demand, and scalability from clinical to commercial.
In this two-part article, Gene Therapy expert Faryar Tavakoli explores the pros and cons associated with cryogenic and refrigerated transport for Cell and Gene Therapy products.
Part I explores Liquid Nitrogen (LN2) Dry Vapor Shipping Systems (Dewars), and Dry Ice Shipping Systems and the advantages and disadvantages of both.
Part II compares the strengths and weaknesses of Cooling Engine (Self-Cooling) Systems, 2–8°C Phase Change Material (PCM) Systems, and the
Commonalities Between Refrigerated And Cryogenic Transport Systems.
Our gene therapy packaging experts have experience creating packaging programs for companies at every stage, crafting your packaging process so you can get on with saving lives. We have Gene Therapy specialists in Packaging Development, Cold Chain, COI (Chain of Identity), and Hazardous Materials Management that work with leading brands to reduce risk, increase speed to market, and develop packaging that keeps products safe throughout the supply chain by providing the following services:
• Packaging Development Management and engineering
• Serialization and Traceability
• Cold Chain
• Smart Packaging
• Regulatory Expertise
• Business Processes