Nanofluidic device for continuous multiparameter quality assurance of biologics

Nature Nanotechnology
Sung Hee KoJongyoon Han

Abstract

Process analytical technology (PAT) is critical for the manufacture of high-quality biologics as it enables continuous, real-time and on-line/at-line monitoring during biomanufacturing processes. The conventional analytical tools currently used have many restrictions to realizing the PAT of current and future biomanufacturing. Here we describe a nanofluidic device for the continuous monitoring of biologics' purity and bioactivity with high sensitivity, resolution and speed. Periodic and angled nanofilter arrays served as the molecular sieve structures to conduct a continuous size-based analysis of biologics. A multiparameter quality monitoring of three separate commercial biologic samples within 50 minutes has been demonstrated, with 20 µl of sample consumption, inclusive of dead volume in the reservoirs. Additionally, a proof-of-concept prototype system, which integrates an on-line sample-preparation system and the nanofluidic device, was demonstrated for at-line monitoring. Thus, the system is ideal for on-site monitoring, and the real-time quality assurance of biologics throughout the biomanufacturing processes.

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Citations

Feb 7, 2019·Critical Reviews in Biotechnology·André GuerraJarka Glassey
Jan 27, 2018·Lab on a Chip·Junjie ZhongDavid Sinton
Jan 30, 2020·Nature Reviews. Microbiology·M Fata Moradali, Bernd H A Rehm
Apr 12, 2019·Analytical and Bioanalytical Chemistry·Chen WangXing-Hua Xia
Apr 13, 2021·MAbs·Ohnmar Khanal, Abraham M Lenhoff
Jan 26, 2018·Analytical Chemistry·Caterina MusettiMatthew A Zajac

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