Method for stabilizing analyte structure using antibodies or antibody fragments thereof
AssigneeMedical Analysis Systems, Inc.
InventorsShing F. Kwan, Ivan E. Modrovich, Rebecca J. Hunt
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Abstract
A method for stabilizing analyses with antibodies and antibody fragments comprises dissolving the analyte in a liquid to form a solution, adding analyte-specific antibodies, fragments of such antibodies, or both to the solution, heating the solution, and then cooling and filtering the solution. The filtered solution may be diluted in a suitable matrix.
Claims45
A method for increasing the stability of a protein analyte susceptible to degradation in a liquid solution upon storage, comprising:
- (a) preparing a liquid solution containing the protein analyte;
- (b) adding a stabilizing amount of a stabilizing antibody to the solution containing the analyte, wherein the stabilizing antibody has binding specificity for the analyte in the liquid solution;
- and
- (c) incubating the solution containing the protein analyte and the stabilizing antibody under conditions sufficient to allow the antibody to bind to the protein analyte to form an antibody-analyte complex, wherein the protein analyte in the solution with the stabilizing antibody is stable for at least 72 hours at 4.degree. C.
A method for increasing the stability of a protein analyte susceptible to degradation in a liquid solution upon storage, comprising:
- (a) preparing a liquid solution containing the protein analyte;
- (b) adding a stabilizing amount of a stabilizing antibody to the solution containing the protein analyte, wherein the stabilizing antibody has binding specificity for the analyte in the liquid solution and wherein the stabilizing antibody includes both whole antibody and monovalent binding fragments of antibody;
- and
- (c) incubating the solution containing the protein analyte and the stabilizing antibody under conditions sufficient to allow the antibody to bind to the analyte to form an antibody-analyte complex, whereby the antibody increases the stability of the protein analyte to degradation in the liquid solution upon storage.
A method for preparing a sterile liquid solution containing a protein analyte wherein the analyte has increased stability to degradation upon storage, comprising:
- (a) preparing a liquid solution containing the protein analyte;
- (b) adding a stabilizing amount of a stabilizing antibody to the solution containing the protein analyte, wherein the stabilizing antibody has binding specificity for the analyte in the liquid solution;
- (c) incubating the solution containing analyte and stabilizing antibody under conditions sufficient to allow the antibody to bind to the protein analyte to form an antibody-analyte suitable for aseptic filtration;
- and
- (d) aseptically filtering the incubated solution containing antibody-analyte complex;
- whereby a sterile liquid solution of a protein analyte with increased stability to degradation in a liquid solution upon storage is prepared.
A method for stabilizing a biological activity of a protein analyte in a liquid solution upon storage, comprising:
- (a) preparing a liquid solution containing the protein analyte, wherein the protein analyte exhibits the biological activity in solution;
- (b) adding a stabilizing amount of a stabilizing antibody to the solution containing the analyte, wherein the stabilizing antibody has binding specificity for the analyte in the liquid solution;
- and
- (c) incubating the solution containing analyte and stabilizing antibody under conditions sufficient to allow the antibody to bind to the analyte to form an antibody-analyte complex, and wherein the biological activity of the protein analyte is stable upon binding of the antibody and the analyte in the solution with stabilizing antibody is stable for at least 72 hours at 4.degree. C.
Dependencies are inferred from the claim text.