Technology outlook for real‐time quality attribute and process parameter monitoring in biopharmaceutical development—A review

P. Wasalathanthri, Dhanuka; S. Rehmann, Matthew; Song, Yuanli; Gu, Yan; Mi, Luo; Shao, Chun; Chemmalil, Letha; Lee, Jongchan; Ghose, Sanchayita; C. Borys, Michael; Ding, Julia; Jian Li, Zheng

doi:10.1002/bit.27461

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Technology outlook for real‐time quality attribute and process parameter monitoring in biopharmaceutical development—A review

Shared by NobleBlocks on Jul 1, 2020 • 12:00 AM UTC

Authors:

Dhanuka P. Wasalathanthri

Matthew S. Rehmann

Yuanli Song

Abstract

Abstract Real‐time monitoring of bioprocesses by the integration of analytics at critical unit operations is one of the paramount necessities for quality by design manufacturing and real‐time release (RTR) of biopharmaceuticals. A well‐defined process analytical technology (PAT) roadmap enables the ...

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