Updates on Cold Chain Distribution of Pharmaceuticals & Biologics

New technologies and innovative shipper solutions are supporting protection for sensitive drugs & Biologicals in transit.

As guidance develops to create standard processes for managing product at all stages of cold-chain distribution, manufacturers of temperature-sensitive medicinals have revised their packaging to reach global destinations cost effectively.

At the IQPC 8th Cold Chain Distribution for Pharmaceuticals Global Forum, attendees were updated on guidance in development, and audiences provided input on the United States Pharmacopeia’s (USP) General Chapter <1079>, Good Storage and Shipping Practices guidance chapter.

USP’s Package Storage and Distribution Expert Committee is finishing guidance content for a December 31 deadline, after which the guidance will by released in the next USP update, said Mary Foster, USP committee chairperson and with Catalent Pharma Solutions. “USP received more responses on this Chapter than any they have received before,” said Foster. The 15-member committee, which includes two FDA officials, has reviewed FDA 483 observations and sought input from agencies globally in revising the USP’s current “U.S. centric” guidance, Foster noted.

As companion guidance to Technical Report 39, which describes essential practices for cold-chain distribution, the Parenteral Drug Association (PDA) released this year Tech Report 46, on handling and distribution guidance covering “the last mile.”

Priority Solutions International (PSI; Swedesboro, NJ) has introduced a solution for continuous cold-chain monitoring, including real-time reporting on cargo’s temperature status and location during transit.

A Thermo Fisher Scientific company, PSI provides third-party logistics for pharmaceutical distribution with a niche focus on high-value biologics and temperature-sensitive clinical supplies.

The on-board transmission is designed for large parcels, pallet shippers, or airline RKN containers. Transmitters loaded inside the containers provide continuous monitoring of temperature and location via GPS as the cargo is in transit. The transmitter is programmed to signal the satellite every 15 minutes. Data are sent via a server to PSI’s Web site where customers or PSI’s employees can track the shipments in real time.

A global network of PSI employees armed with scanners read the packages as product is delivered to warehouses or clinical trial sites. The pharma customer enters the shipment tracking number at PSI’s web site to access the consignment’s detailed temperature history.