COLD CHAIN
Biostorage: Closing the Loop in Biopharmaceutical Supply Chain Management
Mark W. Sawicki, PhD
Chief Commercial Officer Cryoport
Shipping and storing clinical trial therapeutics and biospecimens involve more than moving materials from Point A to Point B. In the biopharmaceutical industry, material transport and storage are especially complex operations because the materials cannot be exposed to temperatures outside the range(s) prescribed for storage and/or transport - a phenomenon known as a “temperature excursion.” While frozen materials are shipped and received every day, the logistics surrounding their storage create new challenges for even the largest and most ex- perienced clinical trial networks and supply chain managers.
In the rapidly growing markets for immunotherapies as well as stem cell and other regenerative medicines, one of the most challenging aspects of storing biopharmaceutical materials is the maintenance of the right conditions, especially temperature - which is also important when storing bioanalytical samples, clinical trial samples, vaccines and biomarkers. As a logistical consideration, complete tracking of the condition is critical to ensure the integrity of products during both storage and transport, as improper handling or storage can greatly affect the quality of the material, stability of the analytes/drug product and, by extension, bioanalytical assay outcomes.
Moreover, undocumented freeze-thaw cycles, thermal cycling and pH changes due to improper storage/shipping conditions can lead to the loss of millions of dollars’ worth of biopharmaceutical product and clinical samples. Similarly, analyte instability can negatively affect bioanalytical assays and undermine the robustness of clinical data. It can take months or even years to troubleshoot the problems resulting from poorly performing assays and inconclusive data, not to mention the re- manufacture of biopharmaceutical products. Such challenges thus can greatly affect the development timeline of a new drug at immense cost.
Within the biopharmaceutical industry, the importance of a sound storage/shipping logistics strategy - and the economic ramifications of not having such a strategy - are greatly underappreciated. Alarmingly, it is still common practice to place biologic material in a Styrofoam box with an unmeasured amount of dry ice and to hope for the best. Fortunately, advanced packaging, data monitoring and logistics systems are available that facilitate chain-of-condition and chain-of-custody maintenance. These newer systems allow biopharmaceutical companies to make data-driven logistical decisions, much as they do for drug development and commercialization.
“Storage is a critical element of supply chain management. By adding storage services to cold chain shipping and tracking, the best of the logistics management companies create a more comprehensive, end- to-end service offering for clients of any size,” notes Michael Lebbin, president and CEO of Pacific Bio-Material Management, Inc., a provider of regulatory-compliant storage, transport, management and cold chain logistics of biological materials.
“Increasingly, small and mid-tier biopharmaceutical companies are outsourcing cryogenic supply chain management to logistics partners as a means to preserve their capital for therapeutic development,” Lebbin adds. “At the same time, large biopharma companies are outsourcing cryogenic supply chain solutions to access specialized expertise in cold chain supply, tracking and monitoring, inventory control, quality systems and equipment management, a practice that allows them to focus their internal resources on drug development.”
Considerations for Selecting a Biostorage Partner
There are numerous factors to consider when selecting a storage partner for biopharmaceuticals. Chief among these is compliance with current Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and International Society for Biological Environmental Repositories (ISBER) guidelines. GLP/GMP/GDP/ISBER compliance means having validated cold storage equipment and freezers that are temperature-mapped and connected to backup generators, as well as temperature monitoring and alarms. Storage systems should also incorporate accessioning and inventory management systems that comply with Part 11 of the U.S. Code of Federal Regulations Title 21 (21 CFR, Part 11), which governs electronic records and electronic signatures. There are a number of IT systems available with differing capabilities; some integrate with robotic automated accessioning systems, others integrate with laboratory information management systems (LIMS), and some provide fulfillment capabilities as well.
A second consideration is capacity and, more importantly, capacity within the required temperature bands. For example, large projects for -20°C storage may require a cold room, whereas cell lines or infectious or damaged material may require segregated cryogenic storage.
Pharmaceutical Outsourcing | 36 | November/December 2016
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