A HIGH-CONCENTRATION COMPOSITION OF PD-1 ANTIBODY

Abstract

Provided is a composition comprising Pembrolizumab and a variant thereof, wherein the variant is truncation variant with a N-terminal truncation of a heavy chain of Pembrolizumab, and comprises four peptide chains, wherein a first peptide chain comprises the amino acid sequence set forth in SEQ ID NO: 1 or SEQ ID NO: 3, a second peptide chain comprises the amino acid sequence set forth in SEQ ID NO: 3, and a third peptide chain and a fourth peptide chain comprise the amino acid sequence set forth in SEQ ID NO: 2, and wherein the content of the heavy chain comprising the N-terminal truncation is less than or equal to about 2%, expressed as a percentage of the content of the heavy chain comprising the N-terminal truncation accounting for the total content of heavy chains of Pembrolizumab and the variant thereof in the composition. Also provided is a pharmaceutical formulation comprising the composition.

Inventors

AN, Zhenming
LI, Daoyuan
GUO, Futeng
ZHANG, XINQIANG
YIN, Zhenhao
ZAN, Wenying
JI, Linyun
LIU, Chuanlei
WANG, QINGMIN

Assignees

QILU PHARMACEUTICAL CO., LTD.

Dates

Publication Date: 20260506
Application Date: 20251030