SECTION TITLE COLD CHAIN
It is also important to consider sample recovery capabilities and fulfillment logistics management. When materials are ordered out of storage for analysis, the conditions in which those materials are extracted and transported are of utmost importance. Storage providers must therefore accession and transport materials using “cryo-carts” in order to limit thermal cycling and analyte degradation.
Other considerations come into play when biopharmaceuticals must be routed under extreme conditions, such as in cold weather or tropical climates. Key factors include packaging design and performance, particularly in terms of whether performance has been validated at extreme temperatures; refrigerant volume and rate of evaporation/ sublimation at given temperatures; time exposed to extreme temp- eratures; and a logistics and interdiction strategy to move the shipper to a less hostile environment and/or to secure the biomaterial in the event of a shipper failure. In this case, one may choose to expedite delivery, replenish the refrigerant or move the material to a newly con- ditioned shipper.
In recent years, the biopharmaceutical storage and shipping field has benefited from technological advances that have greatly improved the performance and efficiency of freezers and the IT systems that support them. To a great extent, sample accessioning and inventory management have been automated and directly integrated into a broader IT-based logistics solution, allowing for comprehensive fulfillment, shipment tracking and data monitoring/management from a single location. Basing logistical systems on the cloud enables transparency throughout an entire supply chain while eliminating much of the “busy work.” Such advances are facilitating the design of systems that can develop data chains to track entire histories of specific lots of drug product, while
linking those histories to that of a specific patient sample, thereby enhancing data integrity and the targeting of drugs to patients who are most likely to benefit from them.
Adherence to Best Practices
In addition to the ISBER, numerous organizations - including the World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA) - have issued standards and guidelines for the collection, storage, retrieval and distribution of biologic samples. When selecting a provider of storage and fulfillment services, biopharmaceutical companies should vet suppliers for adherence to the following best practices:
• Business continuity and security ·
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· · · ·
Appropriate environmental controls (24/7), including monitoring and records
Proactive calibration and preventive maintenance
Redundant freezers and/or backup power - uninterruptible power supply and backup generators
Access policy Security systems
Equipment system validation IQ/OQ/PQ Fire prevention/detection plans
pharmoutsourcing.com | 37 | November/December 2016
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