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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
With a new North American headquarters and expanded operations, Almac is furthering its transatlantic approach to contract development and manufacturing.
Almac Group, a contract development and manufacturing organization, officially opened its new North American headquarters in May 2011. The completion of a two-year construction project and $120-million investment for its facilities in Souderton, Pennsylvania, 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 houses more than 800 employees.
“With our rate of growth, it is essential we build capacity in both our Northern Ireland and US operation to ensure the business continues to compete at a global level,” said Almac CEO Alan Armstrong in launching the new facility. “It is a testament to the ambition of our founding Chairman Sir Allen McClay, who originally envisaged this project, and we are proud to have brought it to fruition.”
The new Souderton site integrates the company’s clinical technologies and clinical services activities into one location after being housed in separate locations in Audubon and Yardley, Pennsylvania. Almac consists of five major units: Almac Clinical Services, Almac Clinical Technologies, Almac Sciences, Almac Pharma Sciences, and Almac Diagnostics. Almac Clinical Services provides clinical supply services, such as comparator sourcing, blinding and overencapsulation, packaging and labeling of clinical-trial supplies, and distribution and depot activities. Clinical Technologies provides interactive voice and web-response systems and other like support services. Almac Sciences provides custom-synthesis services and technology. Key functions include: active pharmaceutical ingredient (API) development and manufacturing, biocatalysis screening and selection, route selection, process development, solid-state chemistry services, and development and manufacture of custom peptides, oligonucletides, and proteins. Almac Pharma Services provides pharmaceutical development and drug-product manufacture for all phases of clinical trial supply (Phases 0–IV) and commercialization. Almac Diagnostics provides biomarkers for discovery and validation, bioinformatics, and genomic services.
Almac was founded in 2002 by Allen McClay, although the history of the organization dates back to 1968, when McClay founded the pharmaceutical company Galen in Craigavon, Northern Ireland. Almac’s position in the US dates back to 1995 when Almac Clinical Technologies began operations in 1995 in Princeton, New Jersey, and subsequently moved to Yardley, Pennsylvania. In 1996, Almac Clinical Services started operations in Audubon, Pennsylvania. In 2000, Almac purchased an additional facility in Durham, North Carolina, which it still operates today.
Conceptualization and design of Almac’s North American headquarters began in late 2005 with construction commencing in July 2008. The project was completed on time and turned over to Almac in August 2010. The facility equips Almac to provide planning, packaging, distribution, analysis, and technology for clinical-trial materials.
Inside the facility
The new North American facility is housed on a 40-acre site, with the current 240,000-ft2 facility constructed on 25 acres, allowing 15 acres for future expansion. The facility essentially 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.
Building Two, a 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 the following;
• A controlled-substance vault that meets US Drug Enforcement Agency (DEA) requirements for storage of Schedule I and Schedule II controlled substances with a capacity of 310 pallets
• Temperature- and humidity-controlled 41,150-ft2 warehousing (15 to 25 ° C and 65% relative humidity)
• 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 6,131-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
• A finished goods pharmacy is used for storing clinical patient kits, and surplus finished goods are stored in the warehouse facility.
The facility also contains two data centers that provide disaster-recovery redundancy for the site as well as for Almac’s other US and UK sites.
Manufacturing and primary packaging of clinical supplies are performed in a 20,250-ft2 primary production area. Eight rooms are designed for standard humidity conditions of 45% relative humidity, and an additional eight rooms are designed for low-humidity conditions (i.e., 20% relative humidity). The primary production area supports various manufacturing and open-drug packaging, including encapsulation, small dosage powder-filing for inhalers, tablet splitting, bottling, and blistering. Blending functions are planned for the future. Analaytical and solid-state chemistry services for clinical supplies also are performed at the facility through laboratory space of Almac Sciences.
Secondary packaging of clinical supplies occurs in a 20,780-ft2 production area consisting of 23 production rooms. Temperatures in the secondary production are maintained at 18 to 25 ° C and relative humidity of 65% or less. The secondary production unit supports closed-drug manufacturing and assembly, including manual labeling, semi-automated label (mobile and nonmobile), automated labeling, walleting, cartoning, and assemblies. Additionally, a 163-ft2 cold storeroom provides temporary storage and processing of clinical supplies at cold temperatures (i.e., 2 to 8 ° C).
A 6,070-ft2 label-control area is dedicated for the design, printing, inspection, and storage of clinical labels. Additionally, distribution and distribution-support areas provide space for distribution suites used for the verification and packaging of individual clinical supply orders. A quality approval area is used for the physical audit and release of distribution orders. A staging area is used for holding released orders before courier pick-up, and a bulk-shipment area is used to accommodate the packing of pallet-size distribution orders.