Anti-PD-L1/OX40 bispecific antibody preparation as well as preparation method and application thereof

A bispecific antibody and PD-L1 technology, applied in the direction of antibodies, anti-inflammatory agents, antibody medical components, etc., can solve problems such as the complexity of degradation pathways and the prediction of preparation conditions

Pending Publication Date: 2022-03-08
INNOVENT BIOLOGICS (SUZHOU) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the complexity of the antibodies themselves and their degradation pathways, it is currently not possible to predict the formulation conditions needed to optimize antibody stability

Method used

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  • Anti-PD-L1/OX40 bispecific antibody preparation as well as preparation method and application thereof
  • Anti-PD-L1/OX40 bispecific antibody preparation as well as preparation method and application thereof
  • Anti-PD-L1/OX40 bispecific antibody preparation as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0148] II. Preparation of Formulations

[0149] The present invention provides a stable formulation comprising anti-PD-L1 / OX40 bispecific antibody protein. Anti-PD-L1 / OX40 bispecific antibody proteins used in formulations of the invention can be prepared using techniques known in the art for producing antibodies. For example, antibodies can be produced recombinantly. In a preferred embodiment, the antibodies of the invention are produced recombinantly in 293 cells or CHO cells.

[0150] Antibodies are now widely used as active ingredients of pharmaceuticals. Techniques for purifying therapeutic antibodies to pharmaceutical grade are well known in the art. For example, Tugcu et al. (Maximizing productivity of chromatography steps for purification of monoclonal antibodies, Biotechnology and Bioengineering 99 (2008) 599–613.) describe the use of ion exchange chromatography (anionic IEX and / or cationic CEX chromatography) of monoclonal antibodies following a protein A capture s...

Embodiment 1

[0196] Example 1. Preparation and purification of anti-PD-L1 / OX40 bispecific antibody

[0197] An anti-PD-L1 / OX40 bispecific antibody was obtained as described in PCT Application No. PCT / CN2020 / 073959. The antibody has a peptide chain #1 sequence of SEQ ID NO: 1 and a peptide chain #2 sequence of SEQ ID NO: 7, and is a bispecific antibody. PCT Application No. PCT / CN2020 / 073959 is hereby incorporated by reference in its entirety.

[0198] Briefly, antibodies are expressed recombinantly in CHO cells and purified by filtration, chromatography, virus inactivation, filtration, etc.

Embodiment 2

[0199] Embodiment 2.pH screening test

[0200] 2.1 Experimental steps

[0201] In this example, the effect of pH (5.0-7.0) on the stability of the purified anti-PD-L1 / OX40 bispecific antibody in Example 1 was investigated. A total of 5 pH values ​​were designed, which were 5.0, 5.5, 6.0, 6.5 and 7.0.

[0202] Prepare 10mM histidine, 5% (w / v) sorbitol buffer solution, adjust the pH to 5.0, 5.5, 6.0, 6.5 and 7.0 with hydrochloric acid, and replace the anti-PD-L1 / OX40 bispecific antibody ultrafiltration to In the above buffers with different pH values, adjust the protein content of the sample to about 30mg / ml; and add polysorbate 80 to make the final concentration about 0.2mg / ml; filter and pack into 2R vials, stopper and cap . The above samples were placed under the condition of 40°C±2°C for stability investigation, and the specific scheme is shown in the table.

[0203] Table 1. Pre-prescription study protocol

[0204]

[0205] Note: (1) √ indicates sampling at this poi...

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Abstract

The present invention relates to formulations comprising an anti-PD-L1/OX40 bispecific antibody, in particular to pharmaceutical formulations comprising an anti-PD-L1/OX40 bispecific antibody, a buffer, a stabilizer and a surfactant. In addition, the invention also relates to the use of these formulations for the treatment or prevention of diseases.

Description

technical field [0001] The invention relates to the field of anti-PD-L1 / OX40 bispecific antibody preparations. More specifically, the present invention relates to pharmaceutical formulations comprising anti-PD-L1 / OX40 bispecific antibodies, especially stable liquid formulations, lyophilized formulations and reconstituted stable liquid formulations, and methods for preparing said pharmaceutical formulations. Methods, and therapeutic and / or prophylactic uses of said pharmaceutical formulations. Background technique [0002] Drug stability is one of the important indicators to ensure the effectiveness and safety of drugs. Obtaining a good preparation prescription is a key condition to ensure that the drug maintains its effectiveness and safety during the shelf life. However, due to the complexity of the antibodies themselves and their degradation pathways, it is currently not possible to predict the formulation conditions needed to optimize antibody stability. Especially con...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61K9/08A61K9/19A61K47/18A61K47/26A61P35/00A61P37/02A61P29/00A61P31/00A61P43/00A61M5/178A61M5/31
CPCC07K16/2827C07K16/2878A61K9/08A61K9/0019A61K9/19A61K47/183A61K47/26A61P35/00A61P37/02A61P29/00A61P31/00A61P43/00A61M5/178A61M5/31C07K2317/31A61K2039/505A61K2039/54A61K2039/828A61K2039/836
Inventor 朱兴贵马一冬汪音爵
Owner INNOVENT BIOLOGICS (SUZHOU) CO LTD
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