Cambridge Major Laboratories Dedicates New Large-Scale Active Pharmaceutical Ingredient (API) Facility
Company continues to expand in an otherwise down economic environment
July 20, 2009, Germantown WI, USA - Cambridge Major Laboratories (CML) announced it will be Dedicating its new large scale Active Pharmaceutical Ingredient (API) manufacturing facility in Germantown, WI, USA on July 30, 2009. The state-of-the-art facility provides a high quality, US-based API supply option for the pharmaceutical and biotechnology industries, and is in response to CML's need for larger capacity fueled by its growing pipeline of developmental and commercial manufacturing projects.
The facility is designed with six Good Manufacturing Practice (GMP) manufacturing suites capable of producing multi-ton quantities of API's and advanced pharmaceutical intermediates. The installed capacity totals 18,000 gallons (70 cubic meters), with expansion capability for an additional 30,000 gallons (120 cubic meters). In addition, CML has invested in thermal oxidizer 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 solvents.
The new facility comes as part of CML's announced strategy to be the premier, western-based supply option to the pharmaceutical industry. Averaging over 30% annual growth since its inception in 1999, CML expanded from a single location in 2003 to a global presence with four locations in the US and Europe, and a reputation as one of the top pharmaceutical chemistry organizations in the western world. CML's three development centers will funnel products to the new facility for scale up to hundreds of kilograms or ton scale. 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 W. Major, Ph.D., D.Sc., President and CEO, Cambridge Major Laboratories. "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."
"We have an enormous pipeline of promising early and mid-stage drug candidates that we are developing on behalf of our customer base of over 130 emerging and large pharmaceutical companies." said Brian Scanlan, Chief Business Officer, Cambridge Major Laboratories. "In the past, we have had to ultimately divest these opportunities to larger manufacturers due to a lack of capacity. Now we have the horsepower to take our clients new molecules from concept to full commercialization. With all of the hype surrounding drug safety and quality from offshore suppliers, CML's model has shown that US-based manufacturing is still alive and well".
Recently, Cambridge Major completed multi-million dollar investments in its development facilities in Europe including new R&D and analytical laboratories, and additional pilot plant capacity. These investments will add more than 40 percent to CML-Europe's capacity and enable that facility to produce up to 100's of kilograms of API's and intermediates.
CML broke ground on the 125,000 square foot facility in June of 2008. At that time the company announced its investment in high quality western-based assets to offset the migration of drug manufacturing to offshore suppliers. CML believes that the US and Europe have become too reliant on low-cost regions of the world for supply of vital medicines, and as such is building a domestic supply option that ensures security of supply and assurance of quality.
Cambridge Major Laboratories, Inc. is a leading global service-based chemistry outsourcing partner to the pharmaceutical and biotechnology industries, producing pharmaceutical intermediates, Active Pharmaceutical Ingredients, and other fine organic chemicals. The Company specializes in chemical process development and advanced multi-step organic synthesis, and operates from four facilities in the US and Europe. The Company has been FDA inspected and approved for cGMP manufacturing. Visit us at www.c-mlabs.com.