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Grace Opens GMP Release QC Lab at Oregon Facility

To support pharmaceutical intermediates manufacturing

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By: Tim Wright

Editor-in-Chief, Contract Pharma

W. R. Grace & Co. has opened a good manufacturing practice (GMP) release quality control (QC) lab at its fine chemicals manufacturing facility located in Albany, OR, expanding support for GMP manufacturing and release for the pharmaceutical and dietary-related industries.

The new lab’s capabilities will enable the site to validate analytical methods and perform GMP release of starting materials and advanced intermediates. The lab already has passed customer inspections and completed method validation and GMP release of commercial intermediates for major pharmaceutical companies. The analytical equipment in the lab includes HPLC, UPLC, GC-MS, and GC-MS with headspace, along with other common analytical equipment.

“Grace continues to invest and expand our capabilities in custom manufacturing of regulatory materials,” said Brett Reynolds, global business director, fine chemicals, W.R. Grace. “This higher level GMP manufacturing expands our portfolio of products and services to the pharmaceutical and related industries.”

Grace acquired the Albany facility from Synthetech in 2010. The Albany site’s operations team has more than 30 years of custom manufacturing experience in multi-step organic, organometallic, and chiral chemistry, and integrated kilos-to-tons GMP production.

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