PROCESS FOR PREPARING ANTIBODY-DRUG CONJUGATES WITH IMPROVED HOMOGENEITY

Title:

PROCESS FOR PREPARING ANTIBODY-DRUG CONJUGATES WITH IMPROVED HOMOGENEITY

Document Type and Number:

WIPO Patent Application WO/2020/164561

Kind Code:

A1

Abstract:

Provided herein is an applicable bio-conjugation process for preparing antibody-drug conjugates (ADCs) with improved homogeneity. As compared with conventional conjugation process, the homogeneity of antibody-drug conjugate (ADC) products generated from the bio-conjugation process can be dramatically improved. Specifically, in the ADCs prepared by the process disclosed herein, the content of D0+D8 is less than 10 wt% and the content of D6 is less than 10 wt%. Moreover, the content of D4 is generally more than 65 wt%, for example, more than 70 wt%, and more than 77 wt%, while the content of D4 is normally less than 40 wt% in the ADCs prepared by conventional conjugation processes.

Inventors:

JI AO (CN)
SUN CHUCHU (CN)
HE WENXU (CN)

Application Number:

PCT/CN2020/075162

Publication Date:

August 20, 2020

Filing Date:

February 14, 2020

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Assignee:

WUXI BIOLOGICS (SHANGHAI) CO LTD (CN)
WUXI BIOLOGICS IRELAND LTD (IE)

International Classes:

C07K16/00; A61K39/395; A61P35/00; C07K16/28

Domestic Patent References:

WO2011069104A2

2011-06-09

Foreign References:

CN107922477A	2018-04-17
CN104936621A	2015-09-23
CN105849126A	2016-08-10
CN106163559A	2016-11-23
CN106459200A	2017-02-22

Other References: