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.
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