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Protein drug auxiliary screening method

A screening method and protein technology, applied in the field of protein drugs, can solve the problems of high cost of rework, screening out, and platform methods are limited to regular antibodies, etc., and achieve the effect of stable and reliable screening results, short time-consuming, and easy operation

Active Publication Date: 2019-07-16
MABSPACE BIOSCIENCES (SUZHOU) CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Most laboratories now adopt a platform method to screen excipients before the first phase of clinical trials, and use a very simple DOE-like method for screening, because the measured factors are far less than the unmeasured factors, and new protein drugs cannot be screened by the platform method. Excipients, expensive post-rework work, so platform approaches are limited to regular antibodies

Method used

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Examples

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Embodiment 1

[0080] The candidate excipients of the therapeutic protein DR5 antibody are screened according to the protein drug excipient screening method of the present invention, and the obtained dissociation energy values ​​are shown in Table 1 and Table 2 below.

[0081] The candidate excipients include proline, alanine, arginine, glutamic acid, glycine, histidine, mannitol, sucrose, trehalose, sorbitol, citric acid, acetic acid, succinic acid, among which, lemon Acid, acetic acid, succinic acid, and histidine are pH buffering agents, and proline, alanine, arginine, glutamic acid, glycine, mannitol, sucrose, trehalose, and sorbitol are non-pH control auxiliary materials.

[0082] Table 1 Sort of pH buffer

[0083] pH buffer Dissociation energy Absolute value of dissociation energy Citric acid-7.57.5 Succinic acid-5.85.8 Histidine-4.84.8 Acetic acid-4.14.1

[0084] The data in Table 1 shows that the pH buffer with the best stabilizing effect on the therapeutic protein DR5 antibody is a...

Embodiment 2

[0093] The candidate excipients of the therapeutic protein-quaternary Fc-fusion drug molecule Anti-DR5 antibody (abbreviated as DR5 antibody) were screened by routine stability experiments. The experimental results obtained are shown in Table 3a to Table 10 below.

[0094] This example 2 used 4 kinds of protein stabilization systems added with 4 kinds of pH buffering agents respectively, the 4 kinds of protein stabilization systems including citric acid system, acetic acid system, succinic acid system and histidine system, the citric acid system The auxiliary material components and their concentrations and the pH value of the citric acid system are shown in Table 3a. The auxiliary material components and their concentrations of the acetic acid system and the pH value of the acetic acid system are shown in Table 3b. The auxiliary material components of the succinic acid system and The concentration and the pH value of the succinic acid system are shown in Table 3c, and the auxilia...

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Abstract

The invention provides a protein drug auxiliary screening method. The protein drug auxiliary screening method comprises the steps that a therapeutic protein and a plurality of alternate auxiliaries ofthe therapeutic protein are provided, the dissociation energy value between the auxiliaries and the therapeutic protein and the possible binding site of the auxiliaries and the therapeutic protein are analyzed by adopting AutoDockTools software and AggreScan online software to screen the multiple alternate auxiliaries, the screening result has a good corresponding relation to the result of a conventional stability experiment, which proves that the screening result of the protein drug auxiliary screening method is stable and reliable, meanwhile the method is easy and convenient to operate, andconsumes less time, only 1-2 days, to screen auxiliaries each time.

Description

Technical field [0001] The invention relates to the technical field of protein medicines, in particular to a method for screening protein medicine excipients. Background technique [0002] Protein drugs include animal and plant-derived and applied biotechnology research and development protein products that have certain biological activity and are used to prevent and diagnose human, animal and plant diseases, including peptides and genetic engineering drugs, monoclonal antibodies, genetic engineering antibodies, and recombinant Vaccines, etc.; Compared with previous small molecule drugs, protein drugs have the characteristics of high activity, strong specificity, low toxicity, clear biological functions, and are beneficial to clinical applications. [0003] However, the cost of developing a new prescription drug is very expensive. It often takes 10 to 15 years from target selection to drug approval, and the overall success rate is about 10%. In the European Union and the United St...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G16C20/50G16C20/90
CPCG16C20/50G16C20/90
Inventor 魏昱孙强祖
Owner MABSPACE BIOSCIENCES (SUZHOU) CO LTD
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