Hcp antiserum validation using a non-interfering protein stain

一种非干扰性、蛋白质的技术，应用在采用非干扰性蛋白质染剂的HCP抗血清验证领域，能够解决匹配的指定复杂、不正确、模糊匹配等问题

Inactive Publication Date: 2016-02-17
BIO RAD LAB INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, assignment of matches can be complicated when the multiple images or individual features within the images are not in register with each other
Lack of registration between gel and blot images or features within them can be caused by inconsistencies in electrophoresis, transfer, and staining, and that the images can be of different sizes due to shrinkage and swelling of the gel
The reasons for these inconsistencies, among others, can create incorrect or ambiguous matches

Method used

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  • Hcp antiserum validation using a non-interfering protein stain
  • Hcp antiserum validation using a non-interfering protein stain
  • Hcp antiserum validation using a non-interfering protein stain

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[0044] "Polyclonal antibody" refers to a preparation of antibodies, raised against a single antigen, with varying binding specificities and affinities. "Polyclonal antibody cocktail" refers to a mixture of polyclonal antibodies, each raised against a single antigen. Alternatively, "polyclonal antibody mixture" may refer to a mixture of polyclonal antibodies derived from the serum of an animal vaccinated with the antigen mixture. For example, a "polyclonal antibody mixture" may refer to a mixture of polyclonal antibodies obtained from the serum of an animal that has been inoculated with a preparation comprising host cell proteins.

[0045] A "label" or "detectable moiety" is a composition detectable by spectroscopic, photochemical, biochemical, immunochemical, chemical or other physical means. For example, available markers include 32 P, fluorescent dyes, electron-dense reagents, enzymes (e.g., commonly used in ELISAs), biotin, digoxin, or haptens and proteins or other entiti...

Embodiment 1

[0084] introduction

[0085] Biologic drugs face particular supervisory and technical requirements due to their origin / expression in genetically engineered host cells, their underlying physicochemical properties, and the complex purification processes applied in their production. One of these requirements is the accurate monitoring and efficient removal of process-derived impurities such as host cell proteins (HCP), host cell-derived DNA / RNA, viruses, cell culture media, chromatography leachables, etc. (1). Among the different impurities, accurate monitoring of HCP may be the most difficult, because the proteome of the expression system consists of thousands of different proteins, some of which can copurify with the biological substance drug. Therefore, HCP monitoring methods must be multiple analyte assays with the ability to detect most protein impurities that may be present in any batch of drug substance (2,3).

[0086] Enzyme-linked immunosorbent assay (ELISA) is one of...

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Abstract

Methods and compositions are provided for validating immunological detection reagents for use in detecting contaminating host cell components in a biological preparation.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to US Provisional Patent Application No. 61 / 903,234, filed November 12, 2013, which is hereby incorporated by reference in its entirety for all purposes. Background technique [0003] Biologics Drugs or biological substances, such as therapeutic proteins, are generally derived from host cells. For example, host cells can be genetically engineered to produce therapeutic recombinant proteins. As another example, the biological substance can be an endogenous non-recombinant protein. The host cells can be harvested and lysed, and the biological material can then be purified from contaminating host cell components by a variety of methods. Alternatively, the biological material can be secreted by the host cell into the conditioned medium, the medium harvested, and the biological material purified from contaminating material in the conditioned medium. Host cell contaminants include host cell ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/566G01N33/53G01N33/00
CPCG06T7/337G01N33/6803G01N1/30G01N33/15G01N33/6842G01N2001/302
Inventor T·伯克曼
Owner BIO RAD LAB INC
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