SAFC Pharma(TM), a focus area within SAFC(R), a member of the Sigma-Aldrich Group announced that a new reactor at its Arklow (Ireland) manufacturing site has begun operation, expanding the facility's capacity for large-scale active pharmaceutical ingredient (API) manufacturing by approximately 15%. 

The new reactor is the latest in a series of investments designed to enhance production capacity and expand capabilities at the Arklow site, which is the company's global center for the production of commercial and late-stage APIs and advanced intermediates. The $4-million project involved the installation and start-up of a 6,000 liter Hastalloy(R) reactor for large-scale API manufacturing, increasing the total capacity at the site to 96,000 liters, with a reactor range from 250 to 8,000 liters. This latest investment adds capacity for both large- and small-scale manufacturing and improves upon the site's award-winning environmental performance.

The Arklow site is a recognized leader in setting environmental standards and received the PharmaChem Ireland's Responsible Care 2006 Award in the "Environment" category for development of an imaginative approach to reduce and recycle its solvent waste from API processing.

Commenting on the latest expansion in SAFC's global manufacturing, SAFC Pharma Vice President Europe, Dr. Michael Harris commented, "Our continued investment in capabilities and capacity is a direct reflection of SAFC's long-term commitment to meeting customer requirements for API manufacturing. Our continuing investments in facilities and personnel support the growth of SAFC Pharma and underline our position as an industry leader whose focus includes the responsibility to reduce our environmental footprint."

This latest investment complements two additional expansion projects at the Arklow site: the building of a $2.25-million, 15 kg capacity pilot-scale filter dryer designed to double the facility's current capacity for small-scale (10 kg-150 kg) manufacturing of APIs, due for commission in third-quarter 2009; and a $1.8-million expansion of the site's cGMP warehouse capacity, also scheduled for completion in 2009.

"Enhancements to our Ireland site help us strengthen our position as the leading pipeline partner for the pharmaceutical industry, offering complete support for the development, manufacturing and testing of APIs – from preclinical to commercialization stages," concluded Harris.

The 64,000 cubic meter Arklow complex is cGMP, FDA and IMB inspected and fully validated. It supports customers with expertise in new process evaluation, process development validation and technology transfer. The site's special process technologies include carbon coupling reactions, polyamino acids, Suzuki coupling reagents, distillations, salt formations, Grignard chemistry and powder handling, and it is one of the industry's few sites to offer large-scale simulated moving bed (SMB) chromatography for chiral separations.