Cytovance(R) Biologics Launches Cell Banking and Storage Practice; Banking and Storage of Mammalian Cell Lines Complements Cytovance's Existing Process Development and Multi-Product Manufacturing Services.CHICAGO -- Cytovance(R) Biologics today announced the launch of a cGMP-compliant cell banking and storage practice for mammalian cell lines in support of the rapid development and cGMP production of antibody and recombinant protein recombinant protein Molecular biology A protein encoded by recombinant DNA or generated from a recombinant gene. See Recombinant pharmacology. products. The company's cell banking practice operates from 6,000 sq. ft. of newly acquired cleanrooms located adjacent to Cytovance's existing process development laboratories and custom-designed multi-product primary cGMP production facility. Cytovance's mammalian cell banking and storage services are offered to produce, store and monitor cGMP-compliant Master and Working Cell Banks according to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the International Conference on Harmonization har·mo·nize v. har·mo·nized, har·mo·niz·ing, har·mo·niz·es v.tr. 1. To bring or come into agreement or harmony. See Synonyms at agree. 2. Music To provide harmony for (a melody). (ICH See Intel Hub Architecture. ) guidelines. Protocol generation is carefully designed to reflect each client's product indication, development stage, and production process, as well as to ensure that regulatory requirements are met. The company's validated facilities employ a CryoMed 7450 controlled rate freezer and cell lines are stored and monitored in custom BioGenics V1500 liquid nitrogen Noun 1. liquid nitrogen - nitrogen in a liquid state atomic number 7, N, nitrogen - a common nonmetallic element that is normally a colorless odorless tasteless inert diatomic gas; constitutes 78 percent of the atmosphere by volume; a constituent of all living freezers with redundant power supplies for continuous uptime. Cytovance's cleanrooms operate under current cGMP guidelines and are supported by a strong quality assurance and regulatory compliance system. "The establishment, safety and security of cell banks are critical to the successful development of biological products," said William J. Fallon Admiral William Joseph Fallon, USN (born December 30 1944), is the current Commander, U.S. Central Command.[2] ADM Fallon is the first naval officer to hold that position. , president and chief executive officer of Cytovance Biologics. "We are happy to be able to integrate this important service into broader process development and clinical production projects or to provide cGMP cell banking services on a 'stand alone' basis." Cytovance's custom-designed 44,000 square foot biopharmaceutical manufacturing space, located in the Presbyterian Health Foundation Research Park in Oklahoma City Oklahoma City (1990 pop. 444,719), state capital, and seat of Oklahoma co., central Okla., on the North Canadian River; inc. 1890. The state's largest city, it is an important livestock market, a wholesale, distribution, industrial, and financial center, and a farm , Okla., houses its cGMP cell culture and purification production capacity with all associated support In naval air operations, assistance provided by a force or unit to another force or unit that is under independent tactical control, neither being subordinate to the other. See also direct support; support. infrastructure. The facility also features space for expansion of production capacity in support of Cytovance's general business or on a customer-specific basis. Validation of the state-of-the-art facility for cGMP production is anticipated to be completed this summer. About Cytovance Biologics Cytovance Biologics is a biopharmaceutical contract manufacturing company specializing in the production of therapeutic proteins and antibodies from mammalian cell culture. An experienced management team formed the company to address the biotechnology industry's increasing needs for full-service manufacturing capacity at the clinical and early commercial scale. The company offers process development and early stage manufacturing services from its Oklahoma City facilities and will offer full cGMP manufacturing services from its new custom-built facility in mid 2006. |
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