公开(公告)号：US20220396599A1

公开(公告)日：2022-12-15

申请号：US17775386

申请日：2020-11-13

Applicant: AMGEN INC.

Inventor： Yan Wang ,  Nicholas Marchand ,  Robert Perry Brake ,  Maria Perry ,  Ashish Sharma ,  Eugene Sun

IPC: C07K1/34 ,  C07K16/28

Abstract: The present disclosure provides a downstream manufacturing method for the production of bispecific antigen-binding molecule products, which comprise at least two different binding domains. The process comprises at least one filtration step, wherein the filtration is ultrafiltration/diafiltration (UF/DF), and/or viral filtration (VF), wherein a β-cyclodextrin is applied in the process either in a buffer applied in the filtration step or added to the filtration pool after the UF/DF filtration step wherein the buffer or the pool have a concentration of about 0.1 to 3% (m/v) of a (3-cyclodextrin, to preferably keep the product in a non-aggregated form.