Coating processes – Particles – flakes – or granules coated or encapsulated – Solid encapsulation process utilizing an emulsion or...
Reexamination Certificate
1998-07-20
2002-09-03
Nutter, Nathan M. (Department: 1711)
Coating processes
Particles, flakes, or granules coated or encapsulated
Solid encapsulation process utilizing an emulsion or...
C427S213320, C427S213330, C427S213340, C427S213350, C427S213360, C428S402200, C428S402210, C428S402220, C435S177000, C435S178000, C435S179000, C435S180000, C435S181000, C435S182000, C436S528000, C436S529000, C436S530000, C436S531000, C436S532000, C436S533000, C436S534000, C436S535000, C530S812000, C530S813000, C530S814000, C530S815000, C530S816000, C530S817000
Reexamination Certificate
active
06444261
ABSTRACT:
The object of the present invention is a particle resistant to storage, especially a particulate carrier for carrier-bound reactions, detection and/or isolation processes, a process for the production of this particle resistant to storage, and uses of the particle according to the invention.
Particulate carriers consisting of a solid core and a polymer are known as such and have already been used for many purposes. In particular, such particles have been used for immunoassay markers to bond a solid core by means of polymers, e.g., biopolymers, to an affinity component. As particulate material especially sols of metal particles, e.g., magnetic iron particles of colored gold particles, nonmetallic particles, e.g., selenium, coal dust, SiO
2
or ceramic particles, corpuscles or even latex particles of another polymer with different (bonding) properties have been used.
Thus, U.S. Pat. No. 4,230,685 describes an improvement of the bonding of specific binders to magnetic particles, whereby a particle is coated with an acrylate polymer or a polysaccharide, whereby protein A is bonded to this coating by glutaraldehyde.
U.S. Pat. No. 4,452,773 describes the production of magnetic iron-dextran microparticles. These particles have a size of from 100-700 Å, in particular 300-400 Å. A large number of the particles are colloidal and ferromagnetic with a dextran shell. The obtained particles are functionalized by periodate oxidation.
EP-B-452,342 concerns super-paramagnetic particles coated with polysaccharides having colloidal size. The particles can be bonded to additional groups. By sorting out the particle mixture into size subtractions having uniform magnetizations there are obtained compositions having homogeneous properties with regard to the retardance thereof within a magnetic field. The possibility to separate with respect to size is mentioned. Preferred are coatings from polysaccharides or proteins. Polysaccharides are functionalized by periodate oxidation. In addition, functionalization with bromocyanogen is possible. The bonding of the protein shell to particular molecules can be effected by side chain amino groups or sulfhydryl groups.
DE-A-40 37 724 relates to devices for immunoassays in which a direct or indirect markers are used. Direct markers are preferred as they do not require additional steps to visualize test results. Examples for direct markers are metal sols, dye sols, latex particles, color indicators, colorants located in liposomes, and nonmetal sols such as a carbon sol. Another aspect of DE-A-40 37 724 relates to an immunochemically active marker. Then, a coal dust particle is bonded adsorptively to a ligand or a ligand conjugate. The sensitivity of the test for, e.g., human choriongonadotropine hCG is denoted as 25 mIU/ml (IU=international unit).
EP-A-0,410,893 describes a process for the determination and recognition of an antibody within biological fluids directed against a specific antigen. The listed insoluble carrier particles comprise cells, gelatin particles, microcapsules, organic polymers, inorganic fine particles, or colloidal particles of metal or metal compounds being finely dispersed with bovine serum albumin or cholesterol.
Also EP-A-0,032,270 describes a quantitative and/or qualitative determination of an immunologic component using one or several marked compounds being obtained by a direct or indirect coupling of such component(s) to particles from an aqueous dispersion of a hydrophobic dye or pigment or polymeric cores being coated with such dyes or pigments.
EP-0,321,008 relates to a process for the determination of one or several components of a reaction between a specifically bonding protein and the corresponding bondable substance within a sample, the mutual activity of such components and of at least one marked component being obtained by coupling or adsorbing sol particles of the marking directly or indirectly to the component. Preferred sol particles are phosphorus, carbon and/or silicon. Agglutination and aggregation can be prevented by covering the particles with macromolecules containing polar groups such as proteins, poly(ethylene glycol), polymeric carbohydrates, poly(vinyl alcohols), and similar ones. Suitable protective proteins are antigens, antibodies, and anti-antibodies. Immunochemically inert materials such as, e.g., albumin, poly(ethylene glycol), or other polar macromolecules may be used as well. The test sensitivity, e.g., with respect to rabbit immunoglobulin G, is specified as 1.5 ng absolute.
EP-0,298,368 concerns a process for carrying out a diagnostic immunoassay by using colloidal iron metal containing particles having a conjugate attached to them being capable of recognizing specifically the analyte to be determined. The test sensitivity for hCG is in the mIU/ml range.
EP-A-0,280,560 discloses Streptococcus A antigen antibodies being bonded covalently to core/shell polymer particles, the shell being formed from poly(mp-chloromethylstyrene) and the core from poly(styrene-co-2-acetoacetoxidethyl methylacrylate), containing Oil Red EGN within the core to obtain a agglutination reagent.
U.S. Pat. No. 4,452,886 describes the polymerization of lysine with glutaraldehyde and Congo red to colored particles. The test sensitivity for hCG is in the 1000 IU/ml range.
W. P. Collins describes in his book “Alternative Immunoassays”, John Wiley & Sons, Chichester, N.Y., etc., in the chapter “Disperse Dye Immunoassay (DIA)” on page 48-49 the advantages of particle markers and points out the significance of the essential parameters such as particle size, distribution and form, solubility in organic solvents, colloid stability, and bonding capacity, e.g., for antibodies. The test sensitivities mentioned by him are in the mIU/ml range. The conjugates are stable for at least 15 months if they are stored in the lyophilizated state at −20° C. or 4° C.; aqueous conjugates should be consumed within 6 days after preparation.
JP-A-0686771 relates to encapsulated toners and the production thereof.
The inert cores described in the art have been suffering from obvious drawbacks. In case the cores are polymerized therein, the desired core property is impaired too much. In case the polymer is adsorbed on the core with a subsequent covalent or other bonding of the affinity component, the bonding of the core in most cases is too weak, so that the stability is not ensured at longer term. In addition, by employing the methods according to the art only the bonding of one or a small amount of reactive and affinity components is achieved.
The object of the invention consists of providing stable particles with characteristic usable properties, especially marking properties, allowing, if necessary, also numerous reactive components at the same time to be stably bonded thereon. Stability should in particular also comprise a storage at longer terms.
The present invention provides a particle resistant to storage, especially a particulate carrier according to the features of claim 1. Dependent claims 2-18 relate to preferred embodiments of the according to the invention particle. Claim 19 together with the appropriate dependent claims 20 and 22 relate to a process for the production of the particle according to the invention resistant to storage. Claims 23-31 relate to uses of the particle according to the invention.
The particle according to the invention resistant to storage is especially destined for carrier-bound reactions, detection and/or isolation processes. It consists of at least a first and a second component, the particle being suitable to be provided with a reactive component, especially a specific reactive component. The second component consists of a crosslinkable polymer and forms more or less a shell enveloping and/or enclosing the first component as the core at least partially.
The first component has at least one ascertainable property. On the second component there may be arranged reactive components. The particle resistant to storage is characterized by its manufacturing process and available by reacting the first c
Erhardt Christoph
Gromakovskaia Elena
Plaksine Dmitri
Abion Beteiligungs-und Verwaltungsgesellschaft mbH
Jacobson & Holman PLLC
Nutter Nathan M.
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