Safe reliable drug substance transfers via frozen storage and logistics in single-use containers.

As the market for biotherapeutics expands its reach, process transfers continue to increase as new directives promote local final drug product manufacturing for their served market. Biopharmaceutical companies continue to expand their worldwide distribution and drug substance production sites are increasingly de-coupled from their drug product counterpart. Consequently, drug substances are increasingly stored and shipped to remote locations. This is a critical process step yet the challenge to successfully transfer is not well established. One solution is to implement a freezing process in robust single-use containers for safe and reliable storage, and then ship the frozen containers in purpose-designed shippers to safeguard the product and ensure transport integrity. This article introduces the growing need for adoption of freezing operations in biomanufacturing and the typical considerations to implement successfully a global supply chain with product held in a frozen state. Emphasis is given on the required level of thermal and physical qualification of such freeze and thaw systems to adequately protect the product. Finally, the possibility offered by bulk-scale single-use freeze and thaw technologies for “one-way logistics” is described. This concept simplifies the cold chain and increases process efficiency and flexibility.