Albany Molecular Research, Inc. Expanding cGMP Facilities
Albany, NY - Albany Molecular Research, Inc. announced today that it has broken ground on the addition of two new, multipurpose cGMP (current Good Manufacturing Practices) manufacturing suites at its corporate headquarters in Albany, New York. These suites are designed for the synthesis of bulk active pharmaceutical ingredients, suitable for administration to humans, after formulation into appropriate dosage forms. The expansion is in response to growing demand for cGMP synthesis.
"Over the past 12-18 months, we have been experiencing a significant increase in cGMP business," said AMRI President and Chief Operating Officer Donald E. Kuhla, Ph.D. "Our existing cGMP suites are now booked into the summer, we have expanded to a seven-day work schedule, and we continue to see requests for proposals for additional business. We anticipate this trend of increasing demand for our cGMP services will continue well into the foreseeable future."
AMRI currently operates four cGMP suites in Albany. Products prepared in these facilities have been used primarily to support clinical trial studies in various stages of product development research. "Our minority ownership in Organichem Corporation also gives customers a source for cGMP preparation of bulk active ingredients for later stage clinical trials, and commercial quantities for approved products," continued Dr. Kuhla. "We are beginning to see multiple successful examples of projects moving from bench scale at AMRI to initial scale-up in our cGMP manufacturing suites and transfer to Organichem for continued scale-up of larger batches."
To increase capacity, AMRI is building two new cGMP laboratories of 700 and 580 square feet into space at its 21 Corporate Circle facility. Construction and qualification of the new laboratories is expected to be complete by approximately July 2002, at an estimated cost of over $1 million, including supplies and equipment. When finished, the new laboratories will have the capacity to produce up to ten-kilogram batches of intermediates and active pharmaceutical ingredients for use in FDA-approved clinical studies, after subsequent formulation into appropriate dosage forms. Each new laboratory will be capable of carrying out various types of chemistry, including high-pressure catalytic reductions, cryogenic reactions and when necessary a variety of purification protocols, including chromatography. Since FDA-regulated cGMP synthesis requires significant analytical and quality control support, increasing cGMP demand is also leading to growth and investment in both.
AMRI's cGMP business has a global customer base, with customers ranging from biotechnology start-ups to large, established pharmaceutical companies. Added Dr. Kuhla, "While many customers know us for our high quality work in early stage lead discovery and optimization, the expansion of these new facilities further underscores the fact that we have a thriving chemical development, analytical and cGMP business, with similar high standards and entrepreneurial culture."
Promulgated by the U.S. Food and Drug Administration, cGMP regulations and guidelines govern the manufacturing, use and testing of drug products and their components (including active pharmaceutical ingredients) intended for use in humans. Active ingredients manufactured under cGMP standards for clinical research or commercial sale must meet requirements for identity, strength, quality and purity.
"The combination of our strength in bench scale process research and scale-up synthesis to cGMP synthesis to scale-up at Organichem, all provided domestically in the United States, is without match in the industry," added AMRI's Chairman and Chief Executive Officer, Thomas E. D'Ambra, Ph.D. "AMRI's cGMP synthesis and analytical capabilities are also complemented by additional chemical development resources in Syracuse, New York and Mount Prospect, Illinois, which provide rapid response synthesis, kilo lab and non-cGMP scale up, as well as experience and expertise in the use of asymmetric synthesis utilizing chemical catalysis, biocatalysis and fermentation. The development side of AMRI's business is continuing to gain recognition as an important contributor to many new potential drugs under development."
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