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Medicine preparation containing anti-CD20 antibody as well as preparation method and application of medicine preparation

A preparation and antibody technology, which is applied to pharmaceutical preparations containing anti-CD20 antibodies and their preparation and application fields, can solve the problems of different environments and single types of humanized anti-CD20 antibody preparations

Pending Publication Date: 2020-05-29
SHANGAI PHARMA GRP CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The technical problem to be solved by the present invention is to overcome the defects of the single type of humanized anti-CD20 antibody preparations in the prior art, and different preparation environments for different types of humanized anti-CD20 antibodies, and to provide a humanized anti-CD20 antibody containing anti-CD20 Pharmaceutical formulations of antibodies and methods for their preparation and use

Method used

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  • Medicine preparation containing anti-CD20 antibody as well as preparation method and application of medicine preparation
  • Medicine preparation containing anti-CD20 antibody as well as preparation method and application of medicine preparation
  • Medicine preparation containing anti-CD20 antibody as well as preparation method and application of medicine preparation

Examples

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Effect test

preparation example Construction

[0204] 1. Preparation of anti-CD20 humanized monoclonal antibody

[0205] According to the humanized heavy chain variable region sequence (such as SEQ ID NO: 16 shown in Chinese patent application CN 201010150303.3) and light chain variable region sequence (such as the SEQ ID NO: 35 shown in Chinese patent application CN 201010150303.3) , design and synthesize PCR primer oligonucleotide fragments encoding heavy and light chain variable region sequences. Adjacent oligonucleotide fragments overlap by about 18 bases, and PCR primer oligonucleotide fragments generally have a length of about 54 bases. Mix equal amounts of each PCR primer fragment and perform overlap extension PCR reaction.

[0206] PCR reaction system: dNTPs 0.2 μM (final concentration); each PCR primer fragment 1 μl; 10×buffer 3 μl; clonedpfu (Invitrogen) 1 μl; add water to 30 μl.

[0207] PCR reaction conditions: 94°C for 3min→(94°C for 30s→56°C for 30s→72°C for 1min)×30→72°C for 10min.

[0208] The PCR produc...

Embodiment 1

[0217] Example 1: Preparation of highly concentrated anti-CD20 antibody stock solution

[0218] To prepare liquid formulations, humanized anti-CD20 antibodies were buffer exchanged against diafiltration buffer containing the expected buffer composition and, where necessary, concentrated by diafiltration to an antibody concentration of approximately 130 mg / ml. After the diafiltration operation was completed, α,α-trehalose dihydrate, hyaluronidase produced by Suzhou Kangju and polysorbate 80 were added to the antibody solution as stock solutions. Finally, the protein concentration was adjusted to about 120 mg / ml with buffer.

[0219] Table 1

[0220] components concentration anti-CD20 antibody 120mg / mL L-histidine 3.4mM L-Histidine hydrochloride-hydrate 16.6mM L-methionine 10mM Tween 80 (Polysorbate 80) 0.06％ α,α-Trehalose dihydrate 210mM

[0221] All formulations were sterile filtered through a 0.22 μm low protein bindi...

Embodiment 2

[0245] Example 2: Preparation of Humanized Anti-CD20 Liquid Formulation

[0246] To prepare the liquid formulation, the recombinant humanized anti-CD20 antibody (as disclosed in Patent No. ZL201010150303.3) was buffer-exchanged against a diafiltration buffer containing the expected buffer composition, and where necessary, Concentrate to an antibody concentration of approximately 150 mg / ml. After reaching the target concentration, α,α-trehalose dihydrate, hyaluronidase produced by Suzhou Kangju and polysorbate 80 were then added to the antibody solution as stock solutions. Finally, the protein concentration was adjusted to a concentration of approximately 120 mg / ml with the final formulation buffer.

[0247] Table 4

[0248] components concentration anti-CD20 antibody 120mg / mL L-histidine 3.4mM L-Histidine hydrochloride-hydrate 16.6mM L-methionine 10mM Tween 80 (Polysorbate 80) 0.06％ α,α-Trehalose dihydrate 210mM hyalu...

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Abstract

The invention discloses a medicine preparation containing an anti-CD20 antibody as well as a preparation method and an application of the medicine preparation. The medicine preparation comprises 1) 50-200 mg / ml anti-CD20 antibody; 2) 10-50 nM buffering agent which is a histidine buffering agent; 3) 105-420 mM alpha alpha-trehalose dihydrate; 4) 5-20 mM methionine and 5) 0.01%-0.12% of a nonionic surfactant; the medicine preparation containing the anti-CD20 antibody has the pH being 5.5 plus or minus 2.0; and preferably, the medicine preparation also contains hyaluronidase. The medicine preparation containing the anti-CD20 antibody has excellent stability.

Description

[0001] This application claims the priority of the Chinese patent application CN201811403257.6 with the filing date of November 22, 2018. This application cites the full text of the above-mentioned Chinese patent application. In addition, this application cites the full text of Chinese patent application CN 201010150303.3 with an application date of March 17, 2010. technical field [0002] The present invention relates to a pharmaceutical preparation containing anti-CD20 antibody and its preparation method and application. Background technique [0003] The pharmaceutical use of antibodies has increased over the past few years. In many instances, such antibodies are injected or infused via the intravenous (IV) route. However, intravenous infusion has high requirements for the infusion environment and the operation is complicated. The advantage of subcutaneous injection is that it allows medical practitioners to administer drugs to patients and intervene in a relatively sho...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61K38/47A61K47/18A61K47/36A61K47/20A61K47/26A61P35/00A61P35/02A61P1/00A61P1/04A61P25/00A61P37/02A61P5/00A61P9/00A61P29/00A61P19/02A61P17/06A61P11/00A61P13/12A61P7/06A61P15/00A61P5/14A61P21/00A61P17/02
CPCC07K16/2887A61K9/0019A61K47/183A61K47/36A61K47/20A61K47/26A61K38/47A61P35/00A61P35/02A61P1/00A61P1/04A61P25/00A61P37/02A61P5/00A61P9/00A61P29/00A61P19/02A61P17/06A61P11/00A61P13/12A61P7/06A61P15/00A61P5/14A61P21/00A61P17/02A61K2039/505
Inventor 刘彦君柯樱吴光昊高燕波刘煜杜翊付小朋朱剑枫徐翀颿苏义亮
Owner SHANGAI PHARMA GRP CO LTD
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