Validation of the New Single-Use Freeze-PakSTSStorage and Transport Solution Containers

摘要

Production of biologies — whether for clinical development or large-scale manufacturing campaigns intended to be converted to final drug product — often involves frozen storage. It provides manufacturing process flexibility while enabling long-termproduct stability. Products are frozen and stored using a number of technologies: stainless-steel vessels, bottles, carboys, and disposable bags. Although single-use freezing bags are a common choice for storing biologies, challenges with durability persist.