OEM Catalog 2013 - Dako

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Reagent Partnership Division With more than 45 years of experience, we offer you the opportunity to tap into our vast pool of knowledge Introduction to Dako Dako, founded in 1966, is a world class provider of antibodies and diagnostic solutions for the IVD industry. Dako is composed of two divisions: n Pathology Division focusing on anatomic pathology and covering the entire laboratory workflow with reagents, instruments and software. n Reagent Partnership Division focusing on reagents for turbidimetry and flow cytometry as well as for other immunoassay technologies through two sales channels: retail sales of Dako-labeled products sold through distributors and OEM products sold B2B. The company is headquartered in Denmark with manufacturing and research sites in Glostrup, Denmark and Carpinteria, California, USA, and counts a total of 1,000 employees worldwide. 2 Antibody Manufacturing n Concentrate n Certificate of analysis World class assay development for turbidimetry Reagent Partnership Division excels in assay development for turbidimetry, with comprehensive product coverage in the areas of Kidney, Cardiovascular Risk and Patient Profiling. When utilizing our technical expertise and more than 20 years of experience within the field of developing customized assays through close collaboration with our customers, the best premises for mutually beneficial business are set. Our assay product portfolio includes both conventional assays for turbidimetry and particle-enhanced assays. In addition to assays for turbidimetry, Reagent Partnership Division provides numerous antibodies applicable for a variety of immunoassay technologies. As your OEM partner, we cover the entire value chain Reagent Partnership Division produces a comprehensive range of high-quality antibody bulk solutions for our OEM partners giving them the option to choose exactly the product formulation that serves their needs, building on more than 45 years of experience in developing and manufacturing: n Polyclonal antibodies n Monoclonal antibodies n Conjugated antibodies Product Supplier Outsourcing Partner Low High Reagent Bulk n Ready to use n Certificate of analysis Assay Development n Customized Ab n Assay validation n Control, calibrator, buffer n Application note Being a true One Stop Shop, we cover the entire value chain from antibody bulk manufacturing through assay development to bottling and packaging, as illustrated below. By choosing us for assay development, our customers can rely on timely, high-quality solutions and the work of a dedicated team with detailed knowledge of a variety of turbidimetry platforms, product knowhow and experience with design for manufacture. With a track record of successful development projects for the largest IVD companies in the world, we guarantee seamless vendor/partner integration ensuring compliance with our partners’ technical requirements, quality requirements and processes. Kit n Customized kit (bottling and packaging) n Working procedure Reagent Partnership Offering Level of vendor/partner interaction Products & Services Reagents are delivered in different stages of refinement
Polyclonal antibodies Since 1966 Dako has produced a continually widening range of polyclonal antibodies. Extensive knowledge of protein chemistry and immunochemistry, careful selection of animals for immunization, and optimal, long-term immunization schemes form the basis of our highquality products. Most of our polyclonal antibodies are produced in rabbits. This provides several advantages: n Human antibodies reacting with rabbit immunoglobulins occur rarely. Therefore, rabbit antibodies can be used without risk of nonspecific reactions even in sensitive techniques. n A batch of antibody will always consist of the pooled sera from a large number of animals. This eliminates the possibility of a single, atypical antibody predominating and gives minimal batch-to-batch variation. Immunoglobulin fractions: All Dako polyclonal antibodies are offered in the form of immunoglobulin fractions, with a few exceptions. Specificity: Monospecificity of Dako polyclonal antibodies is obtained by the use of highly purified antigens for immunization. Traces of sometimes unavoidable, unwanted antibodies are removed by liquid or, in the majority of cases, by solid phase absorption. Affinity-isolated antibodies: Dako affinity-isolated antibodies are prepared by immune affinity chromatography, using antigens coupled to a solid matrix. The elution and adsorption techniques used guarantee antibodies of high affinity. Applications: Because of their high purity and avidity, Dako polyclonal antibodies are generally well suited for a variety of techniques, including nephelometry, turbidimetry, immuno fix ation, immunoblotting, and qualitative as well as quantitative gel precipitation techniques. Most of our antibodies have proven to be well suited for use in enzyme-linked immuno sorbent assays – ELISA, chemiluminescence assays (CLIA) and lateral flow devices. Monoclonal antibodies Dako produces a wide range of monoclonal mouse antibodies. Each antibody has been carefully selected on the basis of its value, either for research use or for diagnostic purposes. Antibodies from cell cultures: With only a few exceptions, Dako monoclonal antibodies are produced in cell cultures. This gives advantages in the use of the antibodies. For example, background problems are virtually absent with such reagents because all the mouse immunoglobulin molecules are directed against the target antigen. Specificity: Dako monoclonal antibodies are extensively screened on relevant biological material to ascertain that they possess the necessary specificity and give consistent and strong labeling reactions. Solvent: Dako monoclonal antibodies are generally supplied in the liquid form. The majority of unconjugated antibodies are supplied as cell culture supernatants containing 0.05 mol/L Tris/HCL, pH 7.2 and 15 mmol/L sodium azide. The azide can be removed by dialysis or gel filtration if it interferes with the use of the antibody. However, after removal of the azide, the antibody must be stored frozen. Applications: Dako monoclonal antibodies are generally well suited for a variety of immunoassay techniques, e.g. ELISA, chemiluminescence (CLIA) and lateral flow devices. Turbidimetry and nephelometric test systems Within the field of clinical chemistry, Dako has extensive experience in producing reagents for the measurement of proteins in body fluids. These reagents have been developed particularly for turbidimetry, nephelometry, ELISA and other immunoassay techniques. For turbidimetry and nephelometry, we provide a compre hensive range of conventional products, as well as particle- enhanced assays. The products can be used on a variety of different, fully-automated instruments. Dako provides CE-marked application notes for the following instrument platforms: n Roche: Hitachi 911/917, Modular P, Cobas Mira Plus n Siemens: Advia 1650 n Olympus: AU 640 n Beckmann: Immage For other instruments, general application notes are available which provide guidelines for working procedures. For specific requirements, please contact rpsupport@dako.com Manufacturing quality Dako’s manufacturing facilities in Denmark and the USA have established quality management systems designed to live up to the most stringent standards in the in vitro diagnostics industry: International standards: ISO 9001:2008 Quality Management Systems - Requirements ISO 13485:2003 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes Furthermore, Dako is in compliance with Canadian, EU and US regulations, covering: Canada: SOR/98-282 Canadian Medical Device Regulations (CMDR) European Union: 98/79/EC (IVD Directive), Annex IV: EC Certificate - Full Quality Assurance Certificate United States: FDA 21CFR Part 820 Quality System Regulation Please note that the following product lists are not exhaustive. For more information regarding product availability and assay development please contact rpsupport@dako.com. Most of Dako’s polyclonal antibodies are produced in rabbits. Polyclonal antibody production in small animal models mitigates lot-to-lot performance differences
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OEM Catalog 2013 - Dako

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