Record numbers of attendees and exhibitors came together at Philadelphia meeting
It’s an unusual industry meeting where agencies announce new regulations or guidelines and the audience applauds. But that is one perspective on the recent IQPC Cold Chain Distribution for Pharmaceuticals Global Forum (Philadelphia, Sept. 20-23), where an impressive list of groups, including USP Pharmacopeia (USP), International Air Transport Assn. (IATA), International Soc. For Pharmaceutical Engineering (ISPE), International Safe Transit Assn. (ISTA), Transportation Security Administration (TSA) and the UK’s Medicines and Healthcare Products Agency (MHRA) announced new, revised, or draft rules and guidelines to a generally receptive audience.
And that audience was a new record high, according to the conference managers, IQPC (New York). About 550 were in attendance—a more-than 50% increase over the previous year. They, in turn, attracted 57 exhibitors, a near doubling from the previous year.
What’s the buzz? The obvious answer is that the business of storing and delivering temperature-controlled biopharmaceuticals is growing; Pharmaceutical Commerce’s own Biopharma Cold Chain Sourcebook projects a double-digit growth rate over the 2008-2011 period (Pharmaceutical Commerce, April, p. 1). “Business has never been better,” says Mark Mohr, product development manager at Continental Air Cargo (Houston).
Logistics service providers are eager to jump on the bandwagon, as the global logistics industry is still recovering from a disastrous drop-off in activity during 2009. While shipping volumes are on the increase, capacity has remained low, creating looming bottlenecks in shipping lanes or transportation modes. “We took advantage of the industry slowdown to carefully build out our technical capabilities in pharma cold chain,” says David Brooks, president of American Airlines Cargo (Fort Worth, TX), which introduced its ExpediteTC service for pharma a year ago. “Now we’re looking to increase our ground-based cold storage capacity to ensure service continuity for our clients.”
More cold-chain capacity is also apparent among logistics service providers. MD Logistics (Plainfield, IN) will be opening a 55,000-sq.ft., temperature-controlled warehouse in Reno, NV, early next year, the better to provide one-day service to the West Coast. Cavalier Logistics (Dulles, VA) has just opened a 42,000-sq.ft facility in Jessup, MD, expressly for biopharma storage.
Rules and guidelines
The regulatory element is looked on as a difficult but necessary maturation of pharma cold chain (or, to adopt the current lingo, “time- and temperature-sensitive transport”). On one level, it’s about ensuring that critical—often highly expensive—biopharmaceuticals are delivered safely to patients and healthcare institutions. On another level, it’s about the dynamic between manufacturers, their service providers, and customs and health authorities around the world. As the markets for biopharmaceuticals expand internationally, health authorities are looking very critically at drug delivery practices. With better industry guidance in place, manufacturers have a more defensible position to meet the regulatory oversight.
Industry has successfully navigated one of the more recent regulatory issues: the so-called “100% inspection rule” of the Transportation Security Administration.
According to TSA representatives, there are now over 1000 business entities that have been validated in the Certified Cargo Screening Program (CCSP), a rule (not specific to pharma) that came out of the 9/11 Commission Act of 2007. The industry had to prepare for a system where packages going on passenger aircraft as cargo needed to be inspected; CSSP allows manufacturers, logistics providers and carriers to perform the inspection themselves.
In the pharma-specific guidance arena, considerable activity has occurred over the <1079> document of USP, which has been in draft form since the beginning of the year, but received “more comments than any previous USP document,” according to Mary Foster, PharmD, current USP chair of Packaging, Storage and Distribution Expert Committee, and VP, quality, at Catalent Pharma Solutions (Somerset, NJ). A finalized version is expected in the next three months.
Meanwhile, another PDA effort has started up over stability guidelines—how to analyze the effects of temperature excursions on the shelf life of pharmaceuticals, and to give acceptable guidance to regulatory authorities when reviewing shipping records, or to prescribers or patients who might have received out-of-range product and need to determine the product’s efficacy. This committee is headed by Robert Seevers, principal regulatory scientist at Eli Lilly, and Arminda Montero, QA program manager at Abbott Laboraties, and is on track to deliver a draft document to PDA during October.
International practices are also in the scope of the ISPE group, which is developing a Good Practice Guide for temperature-sensitive shipments, the ISTA group, which has developed the ISTA Standard 20 for certifying the laboratories that test insulated container performance, and the IATA group, which has finalized its IATA Chapter 17 guidance for air-cargo shipping procedures, and will be initiating training and auditing procedures, according to Kevin O’Donnell, chair of the IATA Time & Temperature Task Force (and technical advisor at Tegrant Corp.)
But wait—there’s more: A presentation by Ian Holloway, manager of the Defective Medicines Report Centre of the UK’s Medicines and Health Products Regulatory Agency (MHRA), raised the issues of setting guidelines for the pharma shipments exposed to variations in humidity and pressure, or subject to shock and vibration, or the cumulative effects of X-ray radiation (X-rays being one of the accepted ways to inspect pharma packages, per TSA) or even high-energy solar radiation (to which shipments in air cargo flights might be exposed). Some of these concerns might be incorporated into a revised EU GMP Guide expected in the fall of 2011.
Innovations in overpacking (carton, insulation, gel packs) include the use of thermal blankets from AmSafe (Dorset, UK) for controlled-ambient shipping, inflatable insulation liners from Coldpack Systems (San Diego) that use air rather than a solid insulator; and expanded polystyrene (as opposed to the more common expanded polyurethane) from Texas Foams (Bastrop, TX). (Cold Chain Technologies, of Holliston, MA, has also been a provider of polystyrene insulation.) Cryoport (San Diego) has expanded its Cryoport Express service, whereby a shipper purchases a thermal bottle from the company prefilled with liquid nitrogen, sends it to a customer or business partner via Federal Express, and FedEx handles the return of the bottle automatically. This service, primarily for clinical trial materials that need to be kept frozen, takes nearly all of the packaging and logistics responsibilities out of the client’s hands; the bottle is rated at -150°C for 10 days.
Many of the overpacking suppliers are paying attention to sustainability or green initiatives on behalf of their customers. Several of the vendors that make use of expanded polyurethane have created linkages with organizations that recycle that material (although the PUR still has to get from where it was used to where it could be recycled); vendors of vacuum-insulation panels, which are considerably thinner than plastic insulation—but considerably more expensive—offer return services for their clients. Makers of gel packs now use several types of “organic” (as in, bio-based) compounds that are readily disposed with no harm to the environment.
While there continue to be incremental improvements in the overpacking, the options to employ active (powered) containers, especially on aircraft, are attracting a high level of attention. Active containers—essentially, a battery-powered heating/cooling system that can be rolled onto a cargo aircraft—offer the advantage of making overpacking mostly unnecessary. While the shipper must pay for transporting the container itself (which can weigh a metric ton), the container can be filled with more product —less of “shipping air.” And, depending on the service agreement between the shipper and its freight forwarder, it is possible to roll the container off an aircraft, onto a truck and deliver the inventory to the next leg of a delivery (generally, a truck for local delivery).
Two vendors showed so-called LD9 units, which are nearly double the size of existing LD3 units, and can fit four standard pallets (see photos). Envirotainer (Malma Lagga, Sweden), which pioneered this category of active containers several years ago, demonstrated the RAP e2 unit, while Lufthansa Cargo (Frankfurt) showed its Opticooler LD9. The key difference is not unit features, but that Lufthansa Cargo only makes its Opticooler available through its own cargo service, while Envirotainer is one of several firms that lease the units to shippers or carriers for one-time or time-defined use.
“Our appeal is for clients who want our complete control over the shipping process,” says Marvin Bourial, global key account manager for Lufthansa. He adds that the company has obtained both FAA and EASA (European) approval for the device. For its part, Envirotainer has developed a QEP (Qualified Envirotainer Partner) program that certifies carriers and freight forwarders for using the device. Lufthansa’s unit is already in use, with the company planning to have 40 available by the end of the year; Envirotainer is readying the unit for an early 2011 introduction.
Envirotainer claims an internal capacity of 6.38 cu. meters, while Lufthansa claims 6.57. Both units have onboard batteries that power a compressor, as well as heating systems for freeze prevention. Envirotainer rates its unit for 0-25°C service for up to 100 hours (between rechargings), while Lufthansa rates its unit for 2-30°C service.
Along with providing continuity with the physical container of a shipment, logistics vendors are now producing a wide array of methods for continuous monitoring of a shipment. One example is from FedEx (Memphis, TN), which was demonstrating its SensAware system, a combination datalogger/mobile communications device that monitors a shipment’s physical condition, senses location via a GPS link, and connects with the Web for near real-time communications. FedEx is lining up life sciences clients to engage in an extended pilot or demonstration program to mature the technology prior to a full rollout.
Another logistics provider, Priority Solutions International (Swedesboro, NJ) is also commercializing a GPS-enabled monitoring system. The as-yet-unnamed system contains a radio device that enables logistics staff to read stored data with a handheld device, making opening the container unnecessary. Online tracking can be provided as well.
Meanwhile, TCP Reliable (Edison, NJ), a full-line supplier of cold chain packaging, lab services and technology, has announced a partnership between one of its subsidiaries, Alternatives Technologie Pharma (Laval, QE)and a temperature-tag company, PakSense (Boise, ID) whereby PakSense’s Ultra Wireless tags can be monitored by ATP’s xTag system, a radio-frequency reader that can read tag data from up to 300 ft away. The combined system, called ATP Mirador, can be used for continuous monitoring—at the package level—in warehouses or in transit. A variety of communication methods, including IEEE802.15.4 [also known as Zigbee] links the tag to the reader; in turn, the reader can communicate via Ethernet, WiFi or cellular (and can communicate with the GPS system) to report environmental conditions of a shipment or storage period.
A new entrant to the cold chain market, OnAsset Intelligence, Inc. (Irving, TX) is looking to bring its vehicle or container tracking technology to aircraft or refrigerated containers. Its basic component, the Sentry, provides tamper evidence and temperature and vibration monitoring of containers, combined with cellular or satellite communications for real-time tracking. A new version, FlightSafe, is intended for airborne use; the unit automatically powers down its radio during flight (just as airline passengers are told to shut off their cellphones as a plane leaves its gate), then automatically reactivates when the plane has landed, enabling a shipper to download time-stamped location and transit conditions. Several cargo companies are evaluating the technology for use in cold chain shipments of life sciences products, according to Nikki Cuban, VP of marketing for the firm.
Finally, a well-known player in pharma cold chain transportation, LifeConEx (Plantation, FL) has announced version 2.0 of LifeTrack, its online system that essentially takes the worry of actively managing biopharma shipments out of the hands of a manufacturer.
It’s worth noting that no FDA, PDA, MHRA or other industry or governmental body requires real-time tracking of biopharma shipments; all these offerings are essentially competitive one-upmanship among technology, logistics and carrier services. But as both the value and the volume of biopharma shipments increase, the online services may prove to provide real business value. PC