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Albany Molecular Research, Inc. Expanding cGMP Facilities.


Business/Medical Editors

ALBANY, N.Y.--(BUSINESS WIRE)--Feb. 7, 2002

Albany Molecular Research, Inc. (Nasdaq: AMRI AMRI Albany Molecular Research (stock symbol)
AMRI Advanced Magnetic Research Institute (Mocksville, NC)
AMRI Advanced Materials Research Institute
AMRI Adult Movie Review Index
) announced today that it has broken ground on the addition of two new, multipurpose mul·ti·pur·pose  
adj.
Designed or used for several purposes: a multipurpose room; multipurpose software.


multipurpose
Adjective
 cGMP (current Good Manufacturing Practices Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products. ) manufacturing suites at its corporate headquarters in Albany, New York For other uses, see Albany.
Albany is the capital of the State of New York and the county seat of Albany County. Albany lies 136 miles (219 km) north of New York City, and slightly to the south of the juncture of the Mohawk and Hudson Rivers.
.

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 Chief Operating Officer (COO)

The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president.
 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 prom·ul·gate  
tr.v. prom·ul·gat·ed, prom·ul·gat·ing, prom·ul·gates
1. To make known (a decree, for example) by public declaration; announce officially. See Synonyms at announce.

2.
 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 United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , 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
This is the article about the city in New York State. For the city in Sicily, see Syracuse, Sicily. For all other meanings, see Syracuse (disambiguation).


Syracuse (IPA:
 and Mount Prospect, Illinois Mount Prospect, part of Elk Grove Township and Wheeling Township, is a village in Cook County, Illinois about 22 miles northwest of downtown Chicago. Mount Prospect was incorporated as a village in 1917. As of the 2000 census, the village had a total population of 56,265. , which provide rapid response synthesis, kilo Thousand (10 to the 3rd power). Abbreviated "K." For technical specifications, it refers to the precise value 1,024 since computer specifications are based on binary numbers. For example, 64K means 65,536 bytes when referring to memory or storage (64x1024), but a 64K salary means $64,000.  lab and non-cGMP scale up, as well as experience and expertise in the use of asymmetric synthesis asymmetric synthesis

Chemical reaction by which unequal amounts of two product isomers are formed. It is normally not possible to synthesize from materials that do not have optical activity (i.e.
 utilizing chemical catalysis catalysis

Modification (usually acceleration) of a chemical reaction rate by addition of a catalyst, which combines with the reactants but is ultimately regenerated so that its amount remains unchanged and the chemical equilibrium of the conditions of the reaction is not
, 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."

Albany Molecular Research, Inc. is a chemistry-based drug discovery and development company, focusing on applications for new small molecule prescription drugs. The company conducts R&D projects and collaborates with many leading pharmaceutical, biotechnology and genomics companies, and is developing new chemistry technology for potential prescription drug applications.

Statements in this press release that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995 that involve risks and uncertainties. These statements may be identified by forward-looking words such as "may," "could," "should," "would," "will," "intend," "expect," "anticipate," "believe" and "continue" or similar words. Readers should not place undue reliance on our forward-looking statements. The company's actual results may differ materially from such forward-looking statements as a result of numerous factors, some of which the company may not be able to predict and may not be within the company's control. Factors that could cause such differences include, but are not limited to (a) the company's ability to attract and retain experienced scientists, (b) trends in pharmaceutical and biotechnology companies Top 100 Biotechnology Companies
The following is a list of the top 100 biotechnology companies ranked by revenue. The first nine companies qualify for the list of the top 50 pharmaceutical companies.
 outsourcing chemical research and development, (c) the company's ability to take advantage of proprietary technology and expand the scientific tools available to it, (d) the company's ability to timely complete construction of the new laboratories within budget and (e) demand for the company's chemical development and cGMP services to continue at current or increasing levels, as well as those factors discussed in the company's Annual Report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the year ended December 31, 2000 as filed with the Securities and Exchange Commission on April 2, 2001 and the company's other SEC filings. The company does not undertake any duty to and does not intend to update any forward-looking statements contained in this press release after the date of this press release.
COPYRIGHT 2002 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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