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Contract Manufacturing

Scimedx presently performs large scale manufacturing of assay components for its own products and contract manufacturing. Scimedx has automated filling, washing and aspiration equipment for handling microplates for ELISA kits. In addition, Scimedx has computer-controlled label printing system that can print complete labels with bar-coding or just lot number and expiration dating. The filling of liquid components is accomplished by semi-automated dispensing equipment. Production lots of up to 3,000 ELISA kits are routinely produced. Liquid filling of several thousand vials is performed under laminar flow air handling conditions to control bioburden in the products. Scimedx has several years of experience in designing and operating fully automated on-line filling, capping/stoppering/crimping, and labeling equipment for high volume production in plastic and glass bottles. Scimedx has a working familiarity with most equipment manufacturers.

Over 25 years of experience in manufacturing of a variety of diagnostic products, from clinical chemistry reagents using powder fill technology to immunochemical products in solid phase microplates, provides the expertise to identify equipment, materials, techniques and processes which yield reliable diagnostic kits. Their experience with design and operation of fully automated microplate processing systems to fully automated liquid filling lines, allows Scimedx to provide a broad range of services.
Scimedx is actively engaged in contract manufacturing for other companies. Scimedx provides complete service from product development to production to warehousing and shipping to end-users for the client. Scimedx produces private label/contract products for IFA, ELISA and membrane tests.

Large Scale Microbiology Technologies
A wide variety of bacterial and yeast microorganisms have been grown in liquid culture media. Cultures of several hundred liters have been grown and harvested for purification of enzymes and other proteins. Scimedx routinely grows multiple 20 L volumes of Reiter Sorbent (used internally and contract manufacture) for syphilis testing and produces quantities of Treponema pallidum in rabbits for use in its FTA-ABS test. Crithidia is grown for the DNA slides Scimedx sells. Scimedx has grown Toxoplasma gondii for extraction of antigen.

Scimedx has experience in tissue culture of human and animal cell lines. Experience within Scimedx covers a variety of tissue culture techniques for viral propagation for slides or purification of viral antigens for ELISA. Viruses such as Herpes, CMV, EBV, and Rubella have been grown. Scimedx is successful in selling Human Epithelial (HEp2) cells for ANA screening. Scimedx worked with the CDC to develop a series of Legionella DFA and IFA tests and Scimedx pioneered in the commercialization of Legionella products. Scimedx has grown and purified the antigens for Lyme disease testing.























 
 

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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