Cambridge Major Laboratories inaugurates large-scale API facility in Wisconsin

Cambridge Major Laboratories (CML) in the US will open its large-scale Active Pharmaceutical Ingredient (API) manufacturing facility in Germantown, WI, on 30 July 2009. The state-of-the-art plant expands CML's capacity and has been built to handle its growing pipeline of developmental and commercial manufacturing projects.

The facility has six Good Manufacturing Practice (GMP) suites for multi-kilogram quantities of APIs and advanced pharmaceutical intermediates.

The installed capacity totals 70m³, with expansion capability for an additional 120m³.

CML has also invested in thermal oxidiser technology to ensure compliance with EPA and DNR air quality standards, as well as a large-volume tank farm to enable more efficient and cost-effective use of solvent.

Averaging annual growth of more than 30% since its inception in 1999, CML is a global company with four plants in the US and Europe. The company's three development centres will funnel products to the new facility for scale up to hundreds of kg. CML will begin transferring products from existing sites to the new facility in late August 2009.

"Without this site we would never be considered for large-scale commercial manufacturing," said Michael Major, president and ceo.

"By default, those processes that our chemists developed and produced at smaller scale would be lost to other western competitors or offshore suppliers as the need for large-scale manufacturing arises. This new facility eliminates those concerns."

CML broke ground on the 11,500m² facility in June 2008.

The company has also made multi-million dollar investments in its development facilities in the Netherlands, including new r&d and analytical laboratories, and additional pilot plant capacity. This equipment has added more than 40% to CML Europe's capacity.