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Entegris

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

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 devel oping 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 medica tions affordable. Such challenges become more difficult when working with products that must be stored and shipped in a frozen state.

Many pharmaceuticals — monoclonal antibodies, vaccines, and patient-specific therapeutics — must be reliably stored and transported at sub-zero temperatures, requiring a robust cold chain that contin ues throughout downstream processing (Figure 1). Demand for these pharmaceutical products is on the order of hundreds of kilograms per year and contin ues to increase.1 While large manufacturers are already well-equipped to handle these volumes, it is possible for smaller laboratories to quickly adapt to produce a wide variety of specialized drugs and distribute them without compromising safety or increasing financial risk.
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