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As biopharmaceutical development and commercialization increases, companies are expanding their cold-chain capabilities.
The bio/pharmaceutical industry's intensification in product development for biologic-based drugs has had an effect on the demand for supply-chain services for clinical-trial materials and commercial drugs. During the past year, several CDMOs and CMOs have expanded their cold-chain logistics, distribution, and storage capabilities. Other companies, such as third-party logistics providers, also have enhanced their capabilities to serve the pharmaceutical cold chain. These expansions are part of an overall growing market for healthcare cold-chain logistics. The total size of the healthcare cold-chain logistic services market is expected to expand from its current size of $6.1 billion to nearly $9.5 billion by 2016, according to the IMARC Group, a research and advisory firm.
Patricia Van Arnum
Contract-service providers expand
Last May, the CDMO Almac Group opened a new $120-million North American headquarters in Souderton, Pennsylvania, which provides the company with parallel service offerings in the United States and in Europe through the company's Craigavon, Northern Ireland, site. The new 240,000-ft2 North American headquarters integrates the company's clinical technologies and clinical services activities into one location after being housed in separate locations in Audubon and Yardley, Pennsylvania.
(IMAGE: DATACRAFT CO LTD / GETTY IMAGES)
The facility has two interlinked buildings, the first a 74,250-ft2 building providing administrative work space for Almac Clinical Services, Almac Clinical Technologies, Almac Sciences, Almac Pharma Services, and Almac Central Services. A second 166,135-ft2 building, houses production and logistics services, including, packaging, testing, and distribution of clinical supplies. The facility has extensive storage capabilities for pharmaceutical materials, including raw materials, in-process materials, and finished goods. The facility provides a range of storage solutions, including temperature- and humidity-controlled 41,150-ft2 of warehousing (15 to 25 °C and 65% relative humidity) and refrigerated and frozen storage space. A 271,000-ft3 drive-in cold storage unit is maintained at temperatures of 2 to 8 °C, and a 6131-ft3 walk-in storage unit stores products at between–25 and –15 °C. Additional critical storage space is offered through the use of mobile units
In March 2011, in response to increased client demand for cold and dedicated frozen storage capacity for biopharmaceuticals, Almac's Pharma Services business unit expanded its commercial facilities to include an additional 6124 ft2 of cold and frozen storage. The expansion was a joint investment with a commercial client for which Almac provides central European Union importation, warehousing, and distribution services. This space includes dedicated -70 °C, –20 °C, and 2–8 °C storage for drug antibody, drug linker, bulk drug substance, placebo, and filled vials. The company added 20 additional dedicated freezer units to its existing 10 for the storage of the monoclonal antibody and bulk drug substance products.
The opening of its North American headquarters in 2011 and the addition of cold-storage capacity in the EU were in addition to several other expansions in Almac's clinical-trial-materials operations. In January 2012, Almac opened a new £3-million ($4.7 million) 30,000-ft2 building at its Craigavon headquarters, which will house 150 employees from Almac's Clinical Services business. In December 2011, Almac launched a new forecasting platform, Compass, which is designed to improve the accuracy and efficiency of the supply-inventory process during clinical studies. Compass is part of Almac's Supply Chain Management services to aid in the packaging, labeling, and distribution of trial supplies on a global level. Also, in June 2011, Almac's clinical-services business unit increased its presence in the Asia-Pacific region with the addition of five new depots in Japan, Thailand, Hong Kong, and Taiwan, thereby providing the company with 36 depots in its network with another five planned for 2012.
In August 2011, Catalent Pharma Solutions expanded its cold-chain supply and distribution capabilities in all major areas of the company's cold-chain storage and distribution, including 2–8 °C and–80 °C capabilities, in some cases more than tripling existing capacity for storage and distribution. The cold-chain expansions at Catalent's European sites in Bolton, United Kingdom, and Schorndorf, Germany, were scheduled to be completed by the end of 2011.
Catalent also made other key moves to improve its clinical-services business. In October 2011, the company opened an European development and clinical services laboratory in Swindon, United Kingdom. This expansion followed recently expanded clinical-supply service capabilities in Schorndorf, Germany. Also, in 2011, Catalent acquired the clinical-trial supplies business of Aptuit, positioning the company as the number two provider globally in clinical-supply solutions.
Other companies expand
In December 2011, the logistics company UPS agreed to purchase Italy-based Pieffe Group, a pharmaceutical logistics company. The acquisition adds two major healthcare distribution facilities, one in Milan and the other in Rome, to UPS's existing global network. The facilities provide a combined space of nearly 753,500 ft2 , including 12 cold-storage areas, with options for further expansion. These facilities add to UPS's global healthcare distribution footprint of more than 4 million ft2. UPS's existing healthcare network of 30 facilities worldwide offers services, such as temperature-sensitive handling capabilities, regulatory compliance, monitoring and security, kitting and labeling, as well as order management and accounts receivables.
In September 2011, the logistics company DHL launched DHL SmartSensor GMS, a device for temperature monitoring, as an advanced version of the company's SmartSensor RFID. The DHL SmartSensor GSM is a small, high-technology device that is packed inside the DHL shipment and which sends real-time data to the solution's web portal. The device uses GSM (Global System for Mobile Communication) technologies that permit data to be controlled without opening the shipment. The device acts as a data-gathering sensor and sends email or text-message notifications if problems arise during transport, such as a change in temperature or the premature opening up of parcel as the light sensor is activated. The device can be used for land and ocean-freight transports. For air transport, the device's GSM antenna is automatically switched off before take-off. The sensor continues to retrieve data but does not send the information in flight as to not to interfere with the aircraft's electronics, according to a Sept. 22, 2011, DHL press release.
In November 2011, DHL Global Forwarding, the air and freight specialist within the Deutsche Post DHL Group, expanded its services for temperature-controlled shipments. The company entered into a lease with CSafe, a heat-and-cool container provider for the temperature-sensitive air-freight market. The CSafe heat-and-cool containers maintain temperature within a range of 4 °C to 25 °C by means of rechargeable batteries for temperatures ranging from ambient to more extreme temperatures of from –30 °C to 49 °C.
In September 2011, DHL Global Forwarding and Lufthansa Cargo changed their ownership of their 50–50 joint venture, LifeConEx, a life-sciences cold-chain logistics provider, to make it a 100% owned subsidiary of DHL. In April 2011, DHL Global Forwarding opened a new competence center in Vienna to expand services to the life-sciences sector. The facility includes 500 m2 of refrigerated warehouse space for handling temperature-sensitive products to allow them to be prepped for air shipment. The center, located at the Vienna airport, is expected to transship approximately 20,000 pallets annually in temperature ranges of 2–8 °C and 15–25 °C. In addition to the warehousing service, the company offers loading and unloading of refrigerated containers, packing of products, coordination of freight space, and organization of the necessary transport equipment. DHL Freight and LTL ColdChain Europe, a pan-European road-freight pallet network for the life-sciences and healthcare industries, are connected to the Vienna competence center.
In March 2011, Bristol-Myers Squibb selected Exel, part of DHL, to be its third-party logistics provider handling US distribution. As part of the contract, Exel purchased the existing Bristol-Myers Squibb distribution centers in Mount Vernon, Indiana. Exel is providing logistics operations and finished-goods distribution services, including storage and distribution of cold-chain and non-cold-chain products, clinical-trial materials, samples, and exports. Exel also is managing second distribution in Mechanicsburg, Pennsylvania, for Bristol-Myers Squibb.
Movianto Nederland, a logistics and transportation company specializing in pharmaceuticals and healthcare, is building a new warehouse in Oss, the Netherland to offer a large facility for the storage of deep frozen pharmaceutical products. The new warehouse, which will be operational by April 2012, will provide a range of new facilities, such as a deep frozen storage area (< –20 °C) with a capacity for 350 pallets. The 13,000-m2 good-distribution practice (GDP)-compliant warehouse encompasses 21,000 temperature-controlled pallet places, including 17,700 in the area of ambient (15–25 °C) 2200 chilled pallet locations (2–8 °C), and 1100 pallets for narcotics. The facility includes a mezzanine with 1300 m2 for repackaging and relabeling services according to GMP guidelines. The expanded storage capacity will serve as a central European warehouse with a dedicated cross-docking area and bonded warehouse facility. Movianto's transport solution manages freight and distributes the products to local warehouses throughout Europe.
In July 2011, Sherpa Clinical Packaging, a privately held provider of clinical-trial material-management services, opened a new cGMP production facility in San Diego, California, colocated adjacent to the CDMO Althea Technologies campus in Sorrento Valley. Sherpa and Althea entered into a comarketing agreement in March 2011.
Sherpa's new facility includes five controlled access and monitored packaging suites, and walk-in 2–8 °C and –20 °C storage areas. Redundant refrigeration systems, alarms, and onsite emergency backup generator power were specified to minimize potential risks associated with cold storage. "We purpose-built the facility to accommodate the needs of pharmaceutical and biotech clients that require controlled environments for their clinical study materials," said Mark Paiz, president of Sherpa Clinical Packaging," in a July 2011, press release. "The site offers companies conducting clinical studies an option to label, package, store, and distribute on the West Coast, which is particularly important for many biotechnology companies whose products require cold storage."
Marken, a provider of clinical-trial management services, reported in December 2011 that it has expanded its depot network with a new facility in Buenos Aires. The Argentina depot joins Marken's already operational depots in Mexico and Singapore and includes a full range of temperature control, including controlled ambient, cold storage (2–8 °C) and frozen (–20 °C) as well as a secured drug store. Each of Marken's depots offer specimen kit distribution, collection, storage, and management as well as reverse logistics for dosage kits, drugs, and equipment, including reconciliation and certified destruction. Additional depot facilities are being developed in Europe, Asia, and the Americas, according to the company. This expanded network builds on Marken's current Latin America business, which serves over 1200 clinical research investigator sites in the region.
In May 2011, BioStorage Technologies, a provider a sample-management solutions, opened a new biorepository facility in Indianapolis, Indiana. The $4.6-million, 60,000-ft2 facility is dedicated to the preparation, storage, and cold-chain transport of human biological samples for academic centers, CROs, donor programs, and biotechnology companies. The facility expansion provides the company the ability to offer sample-preparation services, including automated liquid handling technology for high-throughput DNA and RNA extraction and verification. The new biorepository facility offers a wide range of storage options, including automated carousel controlled-room temperature storage at 15 °C to 27 °C, bulk sample storage at 15 °C to 27 °C, walk-in cold sample storage at –20 °C to 5 °C, ultra-low temperature storage at –70 °C to –80 °C , and –190 °C vapor-phase liquid nitrogen.
Patricia Van Arnum is a senior editor at Pharmaceutical Technology, 485 Route One South, Bldg F, First Floor, Iselin, NJ 08830 tel. 732.346.3072, firstname.lastname@example.org.