SAFC Manufacturing New High-Quality PharmaGrade Raw Materials at Arklow, Ireland, Plant

Sigma-Aldrich Corporation’s custom manufacturing services business unit, SAFC Commercial, has broadened production at its Arklow, Ireland, facility to include new PharmaGrade products. Production of the raw materials began at the site earlier this year and complements the existing offering of highly regulated active and non-active pharmaceutical ingredients manufactured at the site. All products manufactured at the Arklow facility meet and exceed FDA regulations; follow cGMPs for biopharmaceutical production; and comply with International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) requirements.

“Arklow was chosen for this expansion due to its existing specialised 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."

The new PharmaGrade products manufactured at the Arklow facility include difficult-to-source materials available from research- to commercial-scale volumes. The programme takes advantage of Arklow’s purification, recrystallisation and distillation competencies to manufacture a short list of catalog products in the PharmaGrade line, including benzyl alcohol, ethanolamine, fumaric acid, N-acetyl-DL-tryptophan, sodium benzoate, sodium butyrate and hexylene glycol. These specific products began transitioning to the Arklow facility in Q4 of 2011 and were then upgraded to meet PharmaGrade guidelines before production began this year. There are plans to further expand the PharmaGrade product offering from Arklow with D-galactose expected to launch in Q4 of 2013. 

“With the addition of products being made in Arklow, the PharmaGrade line now encompasses almost 100 products that offer the right quality for our biopharma and pharma customers, as well as providing additional value through quality documentation packages, readily-available inventory and multiple batches to support customer qualification activities,” said Douglas Bowman, SAFC’s Program Manager for PharmaGrade.

SAFC’s Arklow facility was originally purpose-built for products that require alkylation, esterification, ester condensation, reduction and Suzuki coupling, and features additional chromatography, crystallization and milling capabilities. With 64,000 m³ of space, the Arklow facility is fully cGMP compliant and has consistently passed FDA and Irish Medicines Board (IMB) inspections. It features four separate plants and has reactor capacity of more than 94,000 L, including glass-lined, as well as stainless steel reactors, distillation units, various dryers and ovens and controlled sieving, delumping and packaging space.