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.