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Chromos signs agreement with AppTec to manufacture multiple sclerosis drug.


Chromos You may be looking for:
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 Molecular Systems, Inc. (Burnaby, Canada), a public biopharmaceutical company, signed a contract with AppTec Laboratory Services, Inc. (St. Paul, MN) for scale-up and manufacture of its 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  drug product candidate CHR-1103. Chromos has used its proprietary ACE System to engineer cell lines for CHR-1103; AppTec will scale up and manufacture CHR-1103 for use in preclinical toxicology preclinical toxicology (prēˈ·kliˑ·ni·kl t  studies and Phase I clinical trials.

"This contract is an important step forward in the development of CHR-1103," said Alistair Duncan, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Chromos. "We are pleased to use our team's proven expertise in cell line engineering with the ACE System to develop our product candidates cost effectively and to work in partnership with AppTec to manufacture this innovative treatment for multiple sclerosis."

CHR-1103 is one of two drug product candidates gained through Chromos' acquisition of Targeted Molecules Corporation in February 2006. A humanized monoclonal antibody for the treatment of the inflammatory disease, CHR-1103 is being developed initially to treat acute flares associated with relapsing forms of MS. The drug's unique mechanism of action has the potential to reduce the severity of a relapse and stem the residual neurological damage that often

accompanies progression of the disease, positioning CHR-1103 to fill an unmet medical need for an effective acute treatment of MS.

Chromos plans to file an Investigational New Drug (IND) application for CHR-1103 in 2007. The company's second product candidate, CHR-1201, is being developed to treat acute thrombosis and offers the possibility of effective treatment of thrombosis involving the brain without the risk of bleeding. The ACE System is Chromos' proprietary platform for rapidly generating production-quality cell lines. The ACE System's performance, speed and versatility are key advantages for generating cell lines for research, development and manufacture of biopharmaceuticals.

Chromos and AppTec are strategic partners who offer the biopharmaceutical industry a broad range of cell line engineering and contract manufacturing services. The companies formed a non-exclusive co-marketing agreement in February 2005. They are jointly marketing Chromos' expertise with cell line engineering with its ACE System and AppTec's expertise in scale-up, manufacturing and testing of biopharmaceuticals, offering customers a high-yield, fast-track solution.

Chromos is a biopharmaceutical company with two drug development programs focused on inflammatory diseases and thrombotic disorders. The company's lead program, CHR-1103, is a humanized monoclonal antibody being developed as a treatment for acute relapses associated with relapsing forms of MS. Chromos generates revenue from its proprietary platforms - the ACE System and REM technology - to support its drug development programs.

AppTec offers comprehensive testing, contract research and development, and cGMP manufacturing services for biopharmaceuticals, medical devices, cellular therapeutics and tissue-based products from a unique single-source platform.

With its 75,000-square-foot, state-of-the-art facility in Philadelphia, AppTec provides integrated, one-stop services for mammalian-cell-culture-based biopharmaceuticals and cellular therapeutics - from complete testing services, to process development and custom manufacturing, including final formulation and fill. Testing services for the biotechnology/biopharmaceutical industries include cell line characterization, viral and process validation, gene therapy vector testing, molecular biology molecular biology, scientific study of the molecular basis of life processes, including cellular respiration, excretion, and reproduction. The term molecular biology was coined in 1938 by Warren Weaver, then director of the natural sciences program at the Rockefeller , mycoplasma mycoplasma

Any of the bacteria that make up the genus Mycoplasma. They are among the smallest of bacterial organisms. The cell varies from a spherical or pear shape to that of a slender branched filament.
 testing and analytical services.

For medical products, AppTec provides comprehensive biosafety testing including biocompatibility biocompatibility

the quality of not having toxic or injurious effects on biological systems.

biocompatibility 1. The extent to which a foreign, usually implanted, material elicits an immune or other response in a recipient 2.
 (in vivo in vivo /in vi·vo/ (ve´vo) [L.] within the living body.

in vi·vo
adj.
Within a living organism.



in vivo adv.
 and in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment.

in vi·tro
adj.
In an artificial environment outside a living organism.
), chronic toxicity chronic toxicity Toxicology A condition caused by repeated or long-term exposure to low doses of a toxic substance , genotoxicity Genotoxic substances are a type of carcinogen, specifically those capable of causing genetic mutation and of contributing to the development of tumors. This includes both certain chemical compounds and certain types of radiation. , microbiology, chemistry, sterilization validation, viral clearance studies, environmental monitoring, and package testing. Contract services include cGMP processing/manufacturing for cells, tissues, and tissue-based products.

The company has 300 employees, seven sales territory offices located across the United States, and a business development office in Europe.

Chromos Molecular Systems, Inc.

+1-604-415-7132

www.chromos.com
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Publication:BIOTECH Patent News
Date:Mar 1, 2006
Words:569
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