Title:
METHOD FOR OBTAINING HIGH-PURITY HETEROLOGOUS ANTIBODY
Document Type and Number:
WIPO Patent Application WO/2021/136256
Kind Code:
A1
Abstract:
Disclosed is a method for obtaining a high-purity heterologous antibody. The heterologous antibody contains two heavy chains with different amino acid sequences. A mutation is introduced at I253 in the constant region of one of the heavy chains, and further purified with protein A affinity chromatography to obtain a high-purity bispecific antibody, wherein the above-mentioned position of the amino acid is determined according to the EU index of KABAT numbering. In the method, only one mutation is introduced in the heavy chain, and the Ile at position 253 (EU number) in the constant region of the heavy chain is mutated to Asn, that is, the purity of the heterologous antibody can be increased to 99% or more by means of merely one step of protein A affinity chromatography, which simplifies the purification steps and reduces the preparation costs.
Inventors:
ZHOU YI (CN)
Application Number:
PCT/CN2020/140756
Publication Date:
July 08, 2021
Filing Date:
December 29, 2020
Export Citation:
Assignee:
ZHOU YI (CN)
International Classes:
A61K39/395; C12N15/00
Domestic Patent References:
| WO2011008517A2 | 2011-01-20 |
Foreign References:
| CN104220093A | 2014-12-17 | |||
| CN102770537A | 2012-11-07 |
Other References:
ZWOLAK ADAM, ARMSTRONG ANTHONY A., TAM SUSAN H., PARDINAS JOSE R., GOULET DENNIS R., ZHENG SONGMAO, BROSNAN KERRY, EMMELL EVA, LUO: "Modulation of protein A binding allows single-step purification of mouse bispecific antibodies that retain FcRn binding", MABS, LANDES BIOSCIENCE, US, vol. 9, no. 8, 17 November 2017 (2017-11-17), US, pages 1306 - 1316, XP055796073, ISSN: 1942-0862, DOI: 10.1080/19420862.2017.1375639
HUANG BO, LIU FU-FENG, DONG XIAO-YAN, SUN YAN: "Molecular Mechanism of the Affinity Interactions between Protein A and Human Immunoglobulin G1 Revealed by Molecular Simulations", JOURNAL OF PHYSICAL CHEMISTRY PART B, AMERICAN CHEMICAL SOCIETY, US, vol. 115, no. 14, 14 April 2011 (2011-04-14), US, pages 4168 - 4176, XP055825595, ISSN: 1520-6106, DOI: 10.1021/jp111216g
ADAM ZWOLAK, LEETTOLA CATHERINE N., TAM SUSAN H., GOULET DENNIS R., DEREBE MEHABAW G., PARDINAS JOSE R., ZHENG SONGMAO, DECKER ROS: "Rapid Purification of Human Bispecific Antibodies via Selective Modulation of Protein A Binding", SCIENTIFIC REPORTS, vol. 7, no. 1, 1 December 2017 (2017-12-01), pages 1 - 11, XP055574512, DOI: 10.1038/s41598-017-15748-0
HUANG BO, LIU FU-FENG, DONG XIAO-YAN, SUN YAN: "Molecular Mechanism of the Affinity Interactions between Protein A and Human Immunoglobulin G1 Revealed by Molecular Simulations", JOURNAL OF PHYSICAL CHEMISTRY PART B, AMERICAN CHEMICAL SOCIETY, US, vol. 115, no. 14, 14 April 2011 (2011-04-14), US, pages 4168 - 4176, XP055825595, ISSN: 1520-6106, DOI: 10.1021/jp111216g
ADAM ZWOLAK, LEETTOLA CATHERINE N., TAM SUSAN H., GOULET DENNIS R., DEREBE MEHABAW G., PARDINAS JOSE R., ZHENG SONGMAO, DECKER ROS: "Rapid Purification of Human Bispecific Antibodies via Selective Modulation of Protein A Binding", SCIENTIFIC REPORTS, vol. 7, no. 1, 1 December 2017 (2017-12-01), pages 1 - 11, XP055574512, DOI: 10.1038/s41598-017-15748-0
Attorney, Agent or Firm:
SHENZHEN QIANNA PATENT AGENCY LTD (CN)
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