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Accelerating Attribute-Focused Process and Product Development Through the Development and Deployment of Autonomous Process Analytical Technology Platform System
  • +6
  • Chao-Hsiang Wu,
  • Pik Chan,
  • Zac Sarich,
  • Yaokai Duan,
  • Janice Chen,
  • Jiu-Li Song,
  • Mike Berke,
  • Les Miranda,
  • Chetan Goudar
Chao-Hsiang Wu
Amgen Inc

Corresponding Author:chaow@amgen.com

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Pik Chan
Amgen Inc
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Zac Sarich
Amgen Inc
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Yaokai Duan
Amgen Inc
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Janice Chen
Amgen Inc
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Jiu-Li Song
Amgen Inc
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Mike Berke
Amgen Inc
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Les Miranda
Amgen Inc
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Chetan Goudar
Amgen Inc
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Abstract

Enabling real-time monitoring and control of the biomanufacturing processes through product quality insights continues to be an area of focus in the biopharmaceutical industry. The goal is to manufacture products with the desired quality attributes. To realize this rigorous attribute-focused Quality by Design (QbD) approach, it’s critical to support the development of processes that consistently deliver high-quality products and facilitate product commercialization. Time delays associated with off-line analytical testing can limit the speed of process development. Thus, developing and deploying analytical technology is necessary to accelerate process development. In this study, we have developed the Micro Sequential Injection (µSI) process analyzer and the Automatic Assay Preparation Platform (A2P2) system. These innovations address the unmet need for an automatic, online, real-time sample acquisition and preparation platform system for in-process monitoring, control, and release of biopharmaceuticals. These systems can also be deployed in laboratory areas as an off-line analytical system and on the manufacturing floor to enable rapid testing and release of products manufactured in a GMP environment.
07 Jun 2023Submitted to Biotechnology and Bioengineering
08 Jun 2023Assigned to Editor
08 Jun 2023Submission Checks Completed
08 Jun 2023Review(s) Completed, Editorial Evaluation Pending
14 Jul 2023Reviewer(s) Assigned
25 Aug 2023Editorial Decision: Revise Major