公开(公告)号：US20210395298A1

公开(公告)日：2021-12-23

申请号：US17283135

申请日：2019-10-11

Applicant: AMGEN INC.

Inventor： Pavel Bondarenko ,  Pik Chan ,  Neil Soice

IPC: C07K1/18 ,  C07K16/28

Abstract: The present invention provides an improved manufacturing method for the production of bispecific antibody products, which comprise at least two binding domains. The process comprises at least the method comprising a step of refolding the construct, wherein one or more of the domains comprise a disulfide bond, and wherein the construct is contacted with a refolding buffer to refold the construct to its native form, the buffer comprising (i) a redox and/or oxidizing agent having a concentration of at least 0.1 mM and (ii) a chaotropic agent having a concentration >1 M, and wherein the pH of the refolding buffer corresponds to +/−4.5 of the pI value of the first domain or +/−4.0 of the pI value of the entire construct.

公开(公告)号：US20220137061A1

公开(公告)日：2022-05-05

申请号：US17431075

申请日：2020-02-14

Applicant: AMGEN INC.

Inventor： Chao-Hsiang Wu ,  Gang Xue ,  Brandon Zachary Sarich ,  Michael R. Berke ,  Jacob Sebastain ,  Pik Chan

IPC: G01N33/68 ,  G01N30/08 ,  G01N30/20 ,  G01N30/84 ,  G01N30/72 ,  G01N30/88 ,  G01N30/30 ,  C07K1/20

Abstract: Systems and methods that facilitate the automatic (or substantially automatic) preparation of a sample of a product containing molecules for analysis and automatic (or substantially automatic) performance of an assay of that sample. Thus, the preparation and analysis can be performed substantially in-real time, or, in other words, much more quickly than presently allowed by conventional systems and methods.