Alquest Support Yields Vital BLA Clearance for Olympus America.MINNEAPOLIS -- Alquest - the leading contract research organization (CRO) specializing in medical devices and biologics -- recently helped its client, Olympus America, earn a vital clearance for a BLA BLA abbr. Bachelor of Liberal Arts (biologics license application). After providing program management and development support, Alquest was gratified grat·i·fy tr.v. grat·i·fied, grat·i·fy·ing, grat·i·fies 1. To please or satisfy: His achievement gratified his father. See Synonyms at please. 2. to learn that the BLA was cleared by the U.S. Food and Drug Administration (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. ) without a single data point questioned or challenged. "The effort and thoroughness with which our team pursued completion of the Biotest-Olympus BLA are unparalleled," said Alquest President Linda Alexander. "This outcome is a testament to the professionalism of Alquest's regulatory, clinical and quality systems staff." Biotest AG, Olympus' European partner, was the formal applicant for the BLA. Alquest's role in the biologic application process included review and writing of the regulatory strategy and clinical protocol, data entry and analysis, site monitoring See Web analytics. , a quality systems audit of Biotest, preparation of the CMC (Common Messaging Calls) A programming interface specified by the XAPIA as the standard messaging API for X.400 and other messaging systems. CMC is intended to provide a common API for applications that want to become mail enabled. 1. (Chemistry, Manufacturing and Controls) section, as well as FDA follow up. "Alquest has been privileged to be entrusted by Olympus with such important aspects of the TANGO(R) system's development," added Alexander. "Olympus does such great work on behalf of patients and the people who care for them." The Olympus TANGO(R) Automated Blood Bank System and its companion Blood Grouping blood grouping n. The process of identifying an individual's blood group by serologic testing of a sample of blood. Also called blood typing. and Anti-Human Globulin globulin, any of a large family of proteins of a spherical or globular shape that are widely distributed throughout the plant and animal kingdoms. Many of them have been prepared in pure crystalline form. Reagents have been cleared for use 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. . In field trials, the TANGO system showed superior or equivalent specificity and sensitivity for blood group determinations, antibody screening, and donor ABO/Rh confirmation testing. Alquest presently is supporting three other BLAs for its clients. Since its inception in 1993, the firm has served more than 300 medical device and biologics companies. About Alquest, Inc. Alquest is a true full-service contract research organization (CRO) specializing in medical devices and biologics. Since its inception in 1993, Alquest has served more than 300 medical device firms worldwide in the areas of clinical management, regulatory affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: About Olympus Diagnostic Systems Group Olympus Diagnostic Systems Group provides innovative solutions that meet the high productivity demands of hospitals, integrated healthcare delivery networks, reference labs, blood banks and pharmaceutical labs. Olympus offers the broadest standardized line of random access chemistry-immuno analyzers, along with lab automation systems, comprehensive patient safety systems, blood bank analyzers and reagents. Olympus solutions save laboratories time, enhance patient safety, maximize productivity, and deliver fast, reliable results. About Olympus Olympus is a precision technology leader, designing and delivering innovative solutions in healthcare and consumer electronics worldwide. Olympus works collaboratively with its customers and its parent company, Tokyo-based Olympus Corporation, to leverage R&D investment in precision technology and manufacturing processes across diverse business lines. These include: --Gastrointestinal endoscopes, accessories, and minimally invasive surgical products; --Advanced clinical and research microscopes; --Lab automation systems, chemistry-immuno and blood bank analyzers and reagents; and --Digital and film cameras, and digital voice recorders. In the U.S. and Canada, Olympus serves healthcare, scientific and commercial laboratory markets with integrated product solutions and financial, educational and consulting services that help customers efficiently, reliably, safely, and easily achieve superior results. Olympus is the leader in gastrointestinal endoscopy gastrointestinal endoscopy Endoscopy A diagnostic procedure in which a flexible fiberoptic endoscope is passed into the esophagus, stomach, and upper small intestine–depending on the level at which lesions are anticipated Indications Dyspepsia, persistent and clinical and educational microscopes. The company's consumer electronics business spans North and South America. For more information, visit www.olympusamerica.com. About Biotest AG Biotest AG, Dreieich is a pharmaceutical and diagnostics company with approximately 1,000 employees world-wide. Biotest is specialized in the development, production and marketing of therapeutic and diagnostic systems with a focus on clinical immunology, autoimmune disease autoimmune disease, any of a number of abnormal conditions caused when the body produces antibodies to its own substances. In rheumatoid arthritis, a group of antibody molecules called collectively RF, or rheumatoid factor, is complexed to the individual's own gamma , haematology and intensive care medicine. The product portfolio includes human plasma derivatives such as immunoglobulin preparations and blood coagulation factors as well as test systems for transplant and transfusion diagnosis and tests for hygiene monitoring. In addition to further innovative plasma derivatives, Biotest's therapeutic pipeline comprises several monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing candidates. Biotest AG's shares are admitted to Prime Standard trading on the Frankfurt Stock Exchange Frankfurt Stock Exchange The largest of Germany's eight securities exchanges, operated by Deutsche Borse AS. . For more information, visit www.biotest.com |
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