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Research Organics

Company Description
Research Organics, an ISO 9001:2000 primary manufacturer and leading worldwide supplier of high purity biochemicals for molecular biology, diagnostics, cell culture, pharmaceuticals, biopharmaceuticals, life sciences, and biotechnology.

Founded in 1953, Research Organics pioneered manufacture of zwitterionic biological buffers and developed the HEPES buffer as an industry-standard, white, free-flowing powder that is colorless in solution.In the early 1980s, Research Organics built large-scale production facilities at its Cleveland, OH corporate headquarters for bulk manufacture of buffers and biochemicals.Since the 1990s, the company has expanded plant and technical capabilities, adding large-scale process equipment and state-ofthe-art facilities.

Products and Capabilities
Research Organics supplies a broad product line that includes biological buffers, reagent biochemicals, molecular biology-grade products, enzyme substrates, fluorescent compounds, amino acids and derivatives, ACS reagents, USP and FCC products, neurochemicals, and plant tissue culture reagents.

Bulk Production. Research Organics specializes in large-scale production of high purity buffers, reagent biochemicals,and specialty chemicals. Buffers supplied include HEPES, MES, ADA, Bis- Tris, MOPS, PIPES, Tris, BES, Bicine, ACES, and Tricine, and salt derivatives,such as Tris HCl, and HEPES Na, MES Na, and MOPS Na. The company also bulk manufactures unique second-generation Goods buffers, including MOPSO, POPSO, TAPSO, and their sodium salts.

Buffers and biochemical reagents exhibit high clarity, superior solubility,an d minimal trace metal content. All processes use nonanimal-derived raw materials.

Increased batch processing capabilities enable production of up to 1,600-kg lot sizes. Production adheres to a strict ISO 9001:2000 compliant documentation program to assure lot consistency,identification, and traceability. Batch records are required to follow the product through manufacturing, cleaning, testing, packaging, and labeling.

Laboratory Production. Laboratory production offers synthetic and rare amino acids, metabolic intermediates, chromogenic substrates, high-purity fluorescent label compounds and histochemical stains. Lab synthesis quantities range from milligrams to kilograms.

Research Organics offers custom synthesis and scale-up capabilities. Chemists coordinate with customers technical personnel to identify critical specifications and develop compounds suitable for these needs.

Quality Standards
Research Organics is an ISO 9001:2000 certified and registered manufacturer of biochemicals compliant to strict industry and international standards for quality assurance. The companys quality system monitors batch processes to ensure conformance to controlled specifications,procedures and lot traceability. QS inspects all batch lots, utilizes statistical process controls, and adheres to cGMP guidelines in equipment qualification, product testing, methods validation, change control, impurity profiles, stability studies, and out-of-specification procedures.

Quality Control Testing. Quality control tests raw materials and authorizes release into batch processes. Each in-process and final batch lot is tested to conform to internal and customer specifications. Analyt ical results are documented in a lot-specific Certificate of Analysis, provided with each product. QC also conducts trace metal analysis on all biological buffers and applicable reagent biochemicals.

Molecular Biology Grade Testing. Research Organics offers a complete line of molecular biologygrade products, tested for absence of DNase, RNase, and bacterial contaminants.

Special testing services offered for bulk accounts:
Endotoxin testing
USP objectionable organism identification
Protease testing
Cytotoxicity testing
Yeast and mold testing

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