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ARGONAUT DEBUTS PHARMACEUTICAL PROCESS CHEMISTRY WORKSTATION.


Argonaut Technologies, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:AGNT AGNT Association for Global New Thought
AGNT Agent Table
) has debuted the Advantage Series 3400 process chemistry workstation for automated compound process research and development. The 3400 workstation is designed to leverage the knowledge and intuition of pharmaceutical process chemists by introducing automated parallel reaction analysis into their laboratory operations. Four removable modular reactors (patent pending), each operating independently under the Camile TG software platform, form the heart of the 3400 workstation. The 3400 workstation can perform virtually all chemistries and reaction conditions that are possible using traditional round-bottom flask Noun 1. round-bottom flask - a spherical flask with a narrow neck
flask - bottle that has a narrow neck
 equipment, but with computer-controlled repeatability and round-the-clock automation. Designed for integration into pharmaceutical NCE NCE Networks of Centres of Excellence
NCE New Chemical Entity (pharmaceutical research)
NCE Normal Curve Equivalent
NCE New Civil Engineer (UK Journal)
NCE Non-Commercial Educational
NCE New Century Energies
 (new chemical entity) process development operations that comply with the FDA's stringent 21 CFR CFR

See: Cost and Freight
 part 11 criteria for electronic records, the 3400 workstation features the Chemcorder workflow replicator See port replicator.

replicator - Any construct that acts to produce copies of itself; this could be a living organism, an idea (see meme), a program (see quine, worm, wabbit, fork bomb, and virus), a pattern in a cellular automaton (see life), or (speculatively) a robot or
 system (patent pending) from Argonaut. The Chemcorder system captures and documents each experiment in a standard formatto meet the needs of departmental review, process scale-up, record-keeping and FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 reporting. The 3400 workstation is the second product introduction in the Advantage Series suite of instrumentation-based systems for process chemistry from Argonaut.

"By focusing Argonaut's engineering and manufacturing resources on pharmaceutical compound process development, we've developed a system that automates experimentation, increases throughput, documents workflow and captures process knowledge for scale-up," said Howard D. Goldstein, senior vice president at Argonaut. "Working with our customers and a consortium of pharmaceutical process development experts, we identified serious inefficiencies in pharmaceutical development that have resulted in a reduction in NCE filings," added Goldstein. "These inefficiencies have not been adequately addressed by other instrumentation manufacturers. Chemists are still acquiring process knowledge for scale-up one experiment at a time manually, or are limited by semi-automated instrumentation that does not integrate into existing infrastructure, does not capture data in an accessible format, and forces chemists to record their experiment by writing down everything they do. The 3400 workstation documents processes and captures data by itself, and integrates readily into existing lab infrastructure and compliant operations. We also made it compact and easy to operate, so chemists can walk up and use the 3400 to design, analyze and apply processes for delivering larger quantities of promising compounds."

The Advantage Series Suite

Process chemistry, the acquisition and application of process knowledge that enables scale-up, is crucial to the success of companies involved in the research and development of new chemical compounds for use as medicines. The 3400 process chemistry workstation joins the 2050 manual chemistry synthesizer synthesizer

Machine that electronically generates and modifies sounds, frequently with the use of a digital computer, for use in the composition of electronic music and in live performance.
 in the Advantage Series suite of instrumentation for pharmaceutical process chemistry from Argonaut. The 2050 manual chemistry synthesizer helps chemists quickly explore various routes of chemical synthesis In chemistry, chemical synthesis is purposeful execution of chemical reactions in order to get a product, or several products. This happens by physical and chemical manipulations usually involving one or more reactions.  leading to the desired compound. The 3400 workstation automates the acquisition of process knowledge that chemists need to synthesize the desired compound reliably, efficiently and reproducibly, and produces analytical quantities of the compound for use in laboratory tests and small clinical trials.

21 CFR part 11 Compliance

Argonaut believes that the Advantage Series 3400 process chemistry workstation meets the definition of a "closed" system as defined by Title 21 of the Code of Federal Regulations Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). . The 3400 workstation includes a number of features to assist process chemists in meeting the technical requirements of 21 CFR part 11 pertaining to closed systems. The 3400 workstation produces an electronic record of all the manual actions of a chemist operating the system throughout an experiment, while creating and saving a recipe that enables the experiment to be reproduced automatically. This electronic data capture also links the data file to the operator with an electronic signature. Operators can link comments to the process run. The electronic record is marked with an encrypted time stamp See timestamp.  and is archived using a method designed to comply with 21 CFR part 11 requirements. The 3400 workstation's operating system operating system (OS)

Software that controls the operation of a computer, directs the input and output of data, keeps track of files, and controls the processing of computer programs.
 can integrate with any electronic signature package that can be embedded into Microsoft Excel (tool) Microsoft Excel - A spreadsheet program from Microsoft, part of their Microsoft Office suite of productivity tools for Microsoft Windows and Macintosh. Excel is probably the most widely used spreadsheet in the world.

Latest version: Excel 97, as of 1997-01-14.
 running under the Microsoft Windows See Windows.

(operating system) Microsoft Windows - Microsoft's proprietary window system and user interface software released in 1985 to run on top of MS-DOS. Widely criticised for being too slow (hence "Windoze", "Microsloth Windows") on the machines available then.
 operating system, enabling integration into existing laboratory information infrastructures.

Under the 3400 workstation's operating system, system administrators assign authority levels to each operator. The 3400 workstation monitors and controls levels of access for those operators and performs checks for uniqueness of electronic signatures. Data pertaining to the validity of passwords and authority of users at the time a record is accessed are captured, linked with the document and encrypted in the audit trail of the document. Argonaut believes that pharmaceutical companies can significantly reduce the time required for data collection and submission by implementing the 3400 workstation's features for technical compliance of closed systems within an environment of compliant operational strategies.

The Advantage Series 3400 process chemistry workstation is now available for demonstration and will be on display at the 7th International Conference on Organic Process Research and Development, to be held in New Orleans New Orleans (ôr`lēənz –lənz, ôrlēnz`), city (2006 pop. 187,525), coextensive with Orleans parish, SE La., between the Mississippi River and Lake Pontchartrain, 107 mi (172 km) by water from the river mouth; founded , March 16 - 19, 2003. Readers are invited to view information on the 3400 workstation by visiting http://www.argotech.com/advantageseries3400/ or by contacting an Argonaut representative by calling 888/650-4200.

About Argonaut

Argonaut Technologies, Inc. is a provider of instruments, chemistry consumables, software, and services designed to accelerate and improve chemical development processes. The company's products enable chemists to increase productivity, reduce operating costs operating costs nplgastos mpl operacionales , achieve faster time-to-market, and explore the increasing number of targets and chemical compounds available for drug and chemical development. Argonaut's products are used in more than 1,000 pharmaceutical, chemical, and academic laboratories worldwide.

Argonaut can be found on the World Wide Web at http://www.argotech.com.

For more information, 650/655-4240.
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Title Annotation:Argonaut Technologies Advantage Series 3400
Publication:Computer Workstations
Geographic Code:1USA
Date:Mar 1, 2003
Words:903
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