Invention Grant
- Patent Title: Method for using light scattering in real time to directly monitor and control impurity removal in purification processes
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Application No.: US16579220Application Date: 2019-09-23
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Publication No.: US11486883B2Publication Date: 2022-11-01
- Inventor: Arthur C. Hewig, III , Duke H. Phan , Yinges Yigzaw , Robert Bailey
- Applicant: AMGEN INC.
- Applicant Address: US CA Thousand Oaks
- Assignee: AMGEN INC.
- Current Assignee: AMGEN INC.
- Current Assignee Address: US CA Thousand Oaks
- Agent Susan E. Lingenfelter
- Main IPC: C07K16/00
- IPC: C07K16/00 ; C07K16/06 ; G01N33/68

Abstract:
The invention provides a method for controlling contaminants in biopharmaceutical purification processes by using light scattering and UV absorbance to establish a determinant. The invention makes use of multi-angle light scattering (MALS) and UV as a continuous monitoring system to provide information about the elution peak fractions in real-time instead of conventional pooling methods that rely on a predetermined percent UV peak max value to initiate the pooling process; regardless of product quality.
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