Enabling cold chain storage in the biopharmaceutical space is a critical factor in supporting the scale-up of many targeted therapeutics. However, many drug manufacturers may neglect to consider the impact of freezing on a drug substance’s critical quality attributes. Safety risks associated with the immunogenicity of a drug substance that has been frozen and thawed, as well as other potential side effects, require an increased focus on particulate generation, compromised efficacy, and other issues that can occur during the freeze/thaw process.
In this article we explore the challenges associated with the cold chain workflow of bulk active pharmaceutical ingredients (APIs), particularly proteins and monoclonal antibodies. By examining a model protein case study, from primary container selection to freeze/thaw methodology to formulation, we also highlight the features of scalable, efficient commercial freeze/thaw unit operations.