SAFC Commercial, the contract manufacturing services division of Sigma-Aldrich, has broadened production at its Arklow, Ireland, facility to include new PharmaGrade products.
Production of the raw materials started at the site earlier this year and complements the highly regulated active and non-active pharmaceutical ingredients already manufactured at the site.
SAFC says all products from the 64,000m3 Arklow facility meet and exceed US Food and Drug Administration (FDA) regulations; follow Current Good Manufacturing Practices (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 products include difficult-to-source materials available from research- to commercial-scale volumes. They take advantage of Arklow's purification, recrystallisation and distillation competencies to manufacture a short list of catalogue 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, adding D-galactose in the fourth quarter of this year.
'With the addition of products being made in Arklow, the PharmaGrade line now encompasses just under 100 products,' 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, crystallisation and milling capabilities. It features four separate plants and has reactor capacity of more than 94,000 litres including glass-lined, as well as stainless steel reactors, distillation units, various dryers and ovens and controlled sieving, delumping and packaging space.
Hydration tanks at Arklow
