Web Connected Biologistics: Cold Chain Lessons Learned From Pharma

By Kevin O’Donnell, Vice President, Cold Chain Standards, Practices & Compliance, BioLife Solutions, Inc.

There is an unfortunate and deep-seated mind-set pervasive among many in the traditional drug manufacturing industry; that ones’ responsibility to the product ends at their dock door. In truth, shipping a drug product – particularly one that is both time-and temperature-sensitive – is only the beginning of a long and circuitous journey where the variety of potential threats and challenges increases and risks to product quality are heightened the further the product travels from its origin. Typically, a package is left to bumble blindly and blithely through a complex supply chain to its ultimate and eventual destination – an awaiting and grateful patient. The probability that the quality of the product could, to an unquantifiable degree, become compromised along the way is real and warrants a risk-mitigation and management best practices approach. Patients deserve better. We can – and should – do all possible to employ evidence-based best practices in the commercialization, distribution, delivery, and administration of cell and tissue-based regenerative medicine products.

Challenging the status quo
Over the past quarter century, the evolution of insulated packaging systems used for the transport of time and temperature sensitive drugs, vaccines, biologics and other delicate life-saving materials, has advanced at what I have often described as “glacial speed.” Innovative and ingenious are not adjectives typically used to describe this corner of the universe. In fact, if insulated packaging innovation was a color, it would be beige.

The response to the pharmaceutical industry from its solution and service providers is analogous to a panicky parent of a recalcitrant two year-old, where the triad of packaging providers, data monitoring device manufacturers, and logistics services, too readily acquiesce to the chaotic needs and imploring demands, rather than providing pioneering solutions to unmet needs, in anticipation of where that industry is headed.