Rapid Scale-Up of Cold-Chain Operations in Drug Development and Manufacturing

technical paper

Despite the industry challenges posed by the COVID-19 pandemic, novel gene therapy development has adapted and is returning to the spotlight. With this comes
a refocus on the selection of optimal single-use materials for early phase regulatory compliance, which is particularly important for materials used in storage and cryogenic operations.

Understanding the biologic and the materials it contacts, realizing the intricacies of equipment to be used, and leveraging the advantages of different service offerings and partners, these three elements must interact with one another harmoniously to ensure effective cold-chain scale-up. That complex relationship empowers manufacturers to implement efficient, cost-effective solutions.

In this paper, we will:

  • Review key product contact material requirements and available data
  • Examine storage and cryogenic process compatibility with respect to functional performance
  • Consider the case study of a material used in storage applications at commercial scale