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公开(公告)号:US20240083972A1
公开(公告)日:2024-03-14
申请号:US18268639
申请日:2021-12-21
Applicant: AMGEN INC.
Inventor: Eliyahu Kraus , Venkatesh Natarajan , Ritsdeliz Perez Rodriguez , Omar Cruz Nieves
IPC: C07K14/715 , C12N5/00 , C12N5/071
CPC classification number: C07K14/7151 , C12N5/0018 , C12N5/0682 , A61K38/00 , C12N2500/12 , C12N2500/32 , C12N2500/34 , C12N2500/46 , C12N2501/998
Abstract: The disclosure provides a method of producing etanercept from Chinese hamster ovary cells (CHO), the method comprising running an N-1 bioreactor system using a recirculating tangential flow filtration (RTF) or alternating tangential flow filtration (ATF) cell retention device under conditions that maintain a cell aggregate size of at least 20 μm, before running an N production bioreactor.
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公开(公告)号:US20230416667A1
公开(公告)日:2023-12-28
申请号:US18035316
申请日:2021-11-09
Applicant: AMGEN INC.
Inventor: Venkatesh Natarajan , Marco DeLiso , Jeremy Aaron Bezaire , Andrew Cavigli , Jeremy S. Conner , Jon Hunter , Sidney Pehrson , Sarah Whetstone
Abstract: Automated systems and methods for low-pH viral inactivation include adding an elution pool to a first vessel with an acid. Once first vessel pH probes measure sufficiently low pH, the pool is transferred to a second vessel, where the pH is checked again, and the pool is held for a time sufficient to reduce virus concentration to a safe level, and neutralized, filtered, and transferred to a third vessel. Meanwhile, the first vessel is filled with a known-pH buffer, which is checked against readings from first vessel pH probes to determine whether recalibration is needed. After the pool is transferred to the third vessel, the second vessel is filled with a known—pH buffer, which is checked against readings from second vessel pH probes to determine whether recalibration is needed. The process repeats when the known-pH buffer is dumped and a new elution pool is added to the first vessel.
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