There is a growing trend toward development of temperature-sensitive biologic drug substances, such as vaccines, monoclonal antibodies (mAbs), mRNA therapies, gene therapy intermediates and viral vectors. These biologics need to be stored at cold temperatures to maintain their stability and efficacy. However, handling these molecules presents challenges for containment, including breakage. Such challenges are not new to the pharmaceutical industry. Single-use polymer-based containers using conventional materials such as EVA or polyethylene, can become brittle and break under extreme cold temperatures, which are often required when transporting drug substances. Damage sustained to conventional containers can result in lost product and may result in significant costs to manufacturers.
As the industry seeks more robust solutions for single-use cold-chain containers, high strength PTFE (or fluoropolymer) materials provide an appealing option to reduce the risk of product loss due to its mechanical properties over a wide temperature range. Drug containers made from PTFE provide a more robust, cold durable option for storage and transport of frozen biopharmaceuticals.