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SAFC Pharma Completes API Expansion

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By: Tim Wright

Editor-in-Chief, Contract Pharma

SAFC Pharma’s new reactor at its Arklow, manufacturing site has begun operation, expanding the facility’s capacity for large-scale active pharmaceutical ingredient (API) manufacturing by approximately 15%.


The $4 million project involved the installation and start-up of a 6,000 liter Hastalloy 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 adds capacity for both large- and small-scale 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.”


The 64,000-cubic-meter Arklow complex is cGMP, FDA and IMB inspected and validated. It supports new process evaluation, process development validation and technology transfer. The site’s process technologies include carbon coupling reactions, polyamino acids, Suzuki coupling reagents, distillations, salt formations, Grignard chemistry and powder handling, and large-scale simulated moving bed (SMB) chromatography for chiral separations.


Other expansion projects at the Arklow site include 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, and a $1.8-million expansion of the site’s cGMP warehouse capacity.

 

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