Protection of proteins and the like

• US 4,891,319 A
• Filed: 05/07/1987
• Issued: 01/02/1990
• Est. Priority Date: 07/09/1985
• Status: Expired due to Term

• Current Assignee: Quadrant Drug Delivery Limited (Vectura Group Ltd.)
• Original Assignee: Quadrant Bioresources Ltd.
• Inventors: Roser, Bruce J.
• Primary Examiner(s): Wax, Robert A.
• Application Number:
  US07/026,695
• Time in Patent Office: 971 Days
• Field of Search: 435/176, 435/178, 435/188, 530/350, 530/380, 530/802, 530/830, 536/56, 536/102, 536/112, 424/85, 424/88
• US Class Current: 435/188
• CPC Class Codes: A61K 35/16 Blood plasma; Blood serum umbilical cord blood A61K35/51
• CPC Class Codes: A61K 39/00 Medicinal preparations containing antigens or antibodies materials for immunoassay G01N33/53
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: C07K 1/00 General methods for the preparation of peptides , i.e. processes for the organic chemical preparation of peptides or proteins of any length
• CPC Class Codes: C07K 16/00 Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies antibodies with enzymatic activity, e.g. abzymes C12N9/0002
• CPC Class Codes: C12N 9/96 Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
• CPC Class Codes: G01N 33/50 Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q
• CPC Class Codes: G01N 33/531 Production of immunochemical test materials
• CPC Class Codes: Y10S 530/802 Chromogenic or luminescent peptides
• CPC Class Codes: Y10S 530/83 Plasma; serum

Abstract

Sensitive proteins and other macromolecules, such as enzymes, antibodies, antigens, serum complement, fluorescent proteins, vaccine components, polysaccharides such as agarose etc, can be preserved by drying at ambient temperature and at atmospheric pressure in the presence of trehalose. A porous matrix impregnated with trehalose is provided as a receiver for a blood or other liquid sample to be dried.

Claims

1. A method of protecting proteins or other biological macromolecules against denaturation during drying, comprising subjecting an aqueous system containing the protein or other biological macromolecule to drying at a temperature above freezing in the presence of trehalose in an amount between about 0.05 and 20 weight percent based on the total weight of said aqueous system.

2. A method according to claim 1, in which the ratio of trehalose to protein or other biological macromolecule is at least 1.4:

1 by weight.

3. A method according to claim 1, in which the protein or other biological macromolecule forms part of a substance selected from the group including an enzyme serum, serum complement, an antibody, an antigen, a fluorescent protein, a vaccine component and a polysaccharide.

4. A method according to claim 1, in which the system is dried at ambient temperature or above and at atmospheric pressure.

8. The method of claim 1, wherein the presence of trehalose is impregnated into a porous matrix.

9. The method of claim 8, wherein said porous matrix contains 5-25% by weight trehalose based on the total weight of said porous matrix.

10. The method of claim 8, wherein the porous matrix comprises a cellulose or glass-based paper, a porous plastic film, or a fabric.

5. A product dried at a temperature above freezing containing trehalose and a protein or other biological macromolecule in a weight ratio of at least 1.4:

1 respectively.

6. A dried product according to claim 5 containing an enzyme, serum complement, an antibody or antigen, a fluorescent protein, a vaccine component or a polysaccharide.

7. A plate having adhered thereto one or more antibodies dried at a temperature above freezing in the presence of trehalose in an amount at least about 1.4 times greater by weight than the amount of said one or more antibodies.

11. A method for protecting a protein or other biological macromolecule against denaturation during drying comprising subjecting an aqueous system containing said protein or other biological macromolecule to drying at a temperature above freezing in the presence of trehalose in an amount of at least about 1.4 time greater by weight than the amount of said protein or other biological macromolecule.

12. A method for protecting a protein or other biological macromolecule against denaturation during drying comprising subjecting an aqueous system containing said protein or other biological macromolecule to drying at a temperature above freezing in the presence of trehalose in an amount of at least about 0.05 weight percent based on the total weight of said aqueous system.