Deirdre Lowe, Mehak Mehta, Geetha Govindan, Kapil Gupta
Abstract
Biopharmaceutical drug substances (DSs) and drug products (DPs) commonly are stored frozen or refrigerated to maintain stability through long-term storage, handling, and transportation (1). Temperature excursions during storage and transport can affect product quality adversely by compromising the safety and efficacy of these molecules. Thus, cold-chain management throughout the shelf life of these products is a critical component in the supply chain strategy for them.