Sigma-Aldrich (SAFC) will soon offer new solid-form research capabilities at its US high-potency active pharmaceutical ingredients (API) facility in Madison, Wisconsin.
The service expansion has been made possible by the mid-year acquisition of Pharmorphix, a Cambridge, UK-based provider of solid-form research services. Although Pharmorphix's primary operations will still continue to be based in the UK, SAFC's Madison facility has been preparing to install some of the technology used at the site as part of an ongoing $12m (€9.4m) expansion. New research and development support services to be offered at the site include polymorph investigation, salt selection, physicochemical property determinations, pre-formulation profiling, co-crystallization, classical chiral resolution and crystallisation studies. The new capabilities, expected to be in place by the beginning of 2007, are intended to give SAFC added capabilities to provide its US customers with information on the solid state of therapeutics in order to support regulatory and intellectual property submissions. Recently-published FDA guidelines concerning specification of API solid form means that these studies have become crucial to the pharmaceutical industry and are an area that is experiencing rapid growth. In addition, understanding and characterisation of solid form provides valuable intellectual property that can be used to extend the patent life of new therapeutics. "Solid-form research is critical in today's advancing regulatory climate, and we will continue to increase our capabilities in the high-potency area," said Craig Grant, Pharmorphix Project Director. "Adding these capabilities to SAFC Madison will provide US-based customers with local access to rapid turn-around analysis such as XRPD from a cGMP facility." Pharmorphix is the second company this year to be bought by SAFC, whose focus lies in the manufacturing, process development and contract services for small organic APIs and advanced intermediates, and the development of large molecule biopharmaceuticals.
In April, the US-based firm acquired Iropharm, a commercial-scale custom chemical synthesis manufacturing site, based in Arklow, Ireland.