Contract API Manufacturing: The Year in Review

Expansion activity was limited as fine-chemical producers and CMOs of API and intermediates grapple with changing industry fundamentals.
Dec 02, 2011
Volume 35, Issue 12

Patricia Van Arnum
The year 2011 was another year of transition for fine-chemical producers and contract manufacturers of APIs and intermediates. As the pharmaceutical industry as a whole deals with slowing growth, increased generic-drug incursion, reduced R&D productivity, and the financing pinch for smaller and emerging bio/pharmaceutical companies, so do its suppliers. Expansion activity among fine-chemical producers and contract API manufacturers was limited although certain areas, such as high-potency manufacturing, continue to attract investment as do biopharmaceutical manufacturing and related services.

Expansion activity

One of the noteworthy expansions in 2011 was the opening of Almac's new North American headquarters in Souderton, Pennsylvania, in May 2011. The completion of the two-year construction project and $120-million investment 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.

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 similar support services. Almac Sciences provides custom-synthesis services and technology. Key functions include: 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.

In October 2011, Almac announced that it is expanding its manufacturing capacity to over 30 m3 at its European headquarters in Craigavon. The upgraded facility will include reactor vessels, cleanroom product isolation, and drying equipment for highly potent API manufacturing up to 600-kg batch sizes. The company expects the facility to be built, commissioned and validated within the next two years. The company also is expanding its pharmaceutical development services capabilities with a new non-GMP formulation-development facility for the development and scale-up of solid oral dose products, including for high-potency compounds.

Outlook for global contract pharmaceutical manufacturing, research, and packaging
In 2011, other companies reported expansions in high-potency manufacturing. Piramal Healthcare announced that it is performing commercial-scale antibody–drug conjugate (ADC) manufacturing at its Grangemouth, Scotland, facility. The company is currently evaluating plans to build out additional manufacturing suites to accommodate kilogram batch sizes. Several ADC-based therapies are in late-phase clinical trials, approximately one dozen are in Phase I development, and more than 20 are in preclinical development. Earlier this year, Piramal opened a new $400,000-quality-control laboratory suite at its facilities in Grangemouth to support its ADC portfolio.

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