Sigma-Aldrich Corp's custom manufacturing services business unit, SAFC Commercial, has expanded production at its Arklow, Ireland, facility to include new PharmaGrade products. All products manufactured at the facility comply with FDA regulations, cGMP for biopharmaceutical production, and International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) requirements.
The new PharmaGrade products include difficult-to-source materials available from research- to commercial-scale volumes. The program employs Arklow's purification, recrystallization and distillation competencies to manufacture a short list of catalog products, including benzyl alcohol, ethanolamine, fumaric acid, N-acetyl-DL-tryptophan, sodium benzoate, sodium butyrate and hexylene glycol. These products began transitioning to the Arklow facility in 4Q11 and were then upgraded to meet PharmaGrade guidelines before production began this year. The company plans to further expand the PharmaGrade product offering with D-galactose, which is expected to launch 4Q13.
"Arklow was chosen for this expansion due to its existing specialized and highly regulated manufacturing capability," said James Ennis, site manager for SAFC's Arklow Facility. "All PharmaGrade products offer high purity and are manufactured under controlled processes. The PharmaGrade products from Arklow are manufactured under ICH Q7 guidelines."
SAFC Adds PharmaGrade Raw Materials at Arklow
Published October 16, 2013
blog comments powered by Disqus