SAFC Madison adds solid form research to high potency operations
SAFC, a member of the Sigma-Aldrich Group, is adding the capabilities of a UK-based solid-form research specialist to the services offered at high-potency active pharmaceutical ingredients (API) facility in Madison, Wisconsin in the US.
SAFC, a member of the Sigma-Aldrich Group, is adding the capabilities of a UK-based solid-form research specialist to the services offered at high-potency active pharmaceutical ingredients (API) facility in Madison, Wisconsin in the US.
The company says the addition of Cambridge-based Pharmorphix will mean increased support for customers with regulatory and intellectual property submissions. It will use a portion of SAFC Madison's recent $12 million facility expansion. The solid-form research technology is expected to be in place January 2007.
The new services follow SAFC's mid-year acquisition of Pharmorphix, whose focus is to drive molecules into the clinic through understanding and modifying the physical properties of APIs to ensure patient benefit, rapid development and protection of intellectual property. R&d support services include polymorph investigation, salt selection, physicochemical property determinations, pre-formulation profiling, co-crystallization, classical chiral resolution and crystallization studies.
Operating under the SAFC Pharma brand, Pharmorphix's primary operations will continue to be based in its state-of-the-art UK facilities.
Craig Grant, Pharmorphix project director said: "Solid-form research is critical in today's advancing regulatory climate, and we will continue to increase our capabilities in the high-potency area. 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."
SAFC Pharma is focused on cGMP manufacturing, process development and contract services for small organic APIs and advanced intermediates, and the development of large molecule biopharmaceuticals.
The move follows the purchase of the SAFC Arklow, Ireland facility and a large-scale API manufacturing site in St Louis, US, as well as the opening of a new medicinal chemistry facility in Bangalore, India earlier this year. In addition, seven-day week work shift extensions have been introduced at the company's SAFC Gillingham, UK, API manufacturing site and its SAFC Manchester, UK, medicinal chemistry and development facilities.
