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Product Development

Scimedx has been successful in developing niche market kits using the "ELISA" and membrane technologies. The corporate experiences have resulted in the development of over 60 immunosorbent-based tests for autoimmune, infectious diseases, hormones and drugs in microplate, bead, latex, and rapid membrane formats. Scimedx has extensive experience in competitive binding, direct and indirect detection in solid phase immunoassay formats. Experience with multiple antibody-antigen coupling methods and carrier technologies (colloidal gold, EIA, Bead, Latex, Fixed Red Cell, polymers, and RIA) provides a strong basis for a variety of development opportunities. Scimedx also provides contract product development services in these areas.

Binding Technologies
Scimedx has experience in binding proteins to various types of plastics, latex, polymers and membranes. The various types of plastic microplate manufacturers and polymers such as polystyrene, nylon, polycarbonate, and polyvinylchloride have been used for coating of antigens and antibodies by passive absorption and covalent coupling of amino and carboxyl groups. Multi-layered binding techniques usingalbumins, streptavidin, Protein A and others have been used for increased sensitivity and specificity of certain proteins, drugs and small molecular weight peptides. A proprietary patented polymer coating is also available for covalent coupling to any surface. Traditional sandwich direct (antigen) detection, indirect (antibody) detection, and unique competitive binding assays have been developed. Stabilization of the coated products has been accomplished through the use of various protein, chemical and carbohydrate compounds by air-dried and lyophilization procedures. Pouching is performed in a humidity-controlled room.

Agglutination Technologies
In addition to strong solid phase immunosorbent technology, there are other corporate experiences in the large scale manufacturing of latex tests. Critical steps for the manufacture of latex tests for a variety of infectious diseases (bacteria and viral) and pregnancy have been identified, such as qualification of raw materials and particles, selection, sizing, sensitization and coating of latex to produce from 10 ml to 10 L of product used in production of kits. The 16 years of work with latex technology offers opportunities to thoroughly understand the fragility of handling, coating, dispensing and lyophilization of latex particles. Turbidimetric and liquid light scattering methods have been developed for selected antibody detection products.

Membrane Technologies
Scimedx has developed a series of membrane based immunosorbent assays for autoimmune diseases. The corporate experience with rapid one-step membrane assays in flow-through and tangential flow formats, using colloidal gold and enzyme conjugates, form the basis for movement into membrane technology for infectious and autoimmune diseases. Scimedx produces and offers membrane-based Western Blot assays. Work with several membrane characteristics for flow, absorption, and binding allows the flexibility to develop rapid tests for many applications. Understanding of the critical requirements for membrane systems offers unique opportunities for products in the point-of-use markets.


 
 

100 Ford Road Suite 100-08 Denville New Jersey USA 07834 tel 973.625.8822 toll-free 800.221.5598 fax 973.625.8796 e-mail info@scimedx.com
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