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.
|
| |
| |
|
 |