Cold-chain Bioprocessing Readiness: Mitigating Risk and Protecting Pharmaceutical Products


This white paper addresses the concerns of development laboratories, contract manufacturing organizations (CMOs), and contract research organizations (CROs) and explains several factors they should consider when expanding operations and selecting single-use systems for cold-chain bioprocessing.


The pharmaceutical industry is migrating rapidly toward a world where drugs, vaccines, and specialized therapies are available on demand to patients anywhere around the globe. Whether accelerating clinical trials to bring new drugs to market or developing biosimilars to give more patients access to established commercial drugs, small and midsize production facilities stand to benefit from growing demand. To do so, however, they must be prepared to handle a broader mix of products and increase throughput without sacrificing safety or reliability, while at the same time keeping life-saving medications affordable. Such challenges become more difficult when working with products that must be stored and shipped in a frozen state.