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.
