Process analytical technique ( <scp>PAT</scp> ) miniaturization for monoclonal antibody aggregate detection in continuous downstream processing

نویسندگان

چکیده

The transition to continuous biomanufacturing is considered the next step reduce costs and improve process robustness in biopharmaceutical industry, while also improving productivity product quality. platform production for monoclonal antibodies (mAbs) eligible processing lower manufacturing due patent expiration subsequent growing competition. One of critical quality attributes interest during mAb purification aggregate formation, with several parameters environmental factors known influence antibody aggregation. Therefore, a real-time measurement monitor formation crucial have immediate feedback control achieve downstream processing. Miniaturized biosensors as an in-line analytical technology tool could play pivotal role facilitate manufacturing. In this review, miniaturization already well-established methods detect protein aggregation, such dynamic light scattering, Raman spectroscopy circular dichroism, will be extensively evaluated possibility providing method evaluation presented review shows which limitations each still need addressed provides application examples technique characterization. Additionally, challenges related are addressed, design microfluidic chip microfabrication material. provided why development key aggregates how it can contribute © 2021 Authors. Journal Chemical Technology Biotechnology published by John Wiley & Sons Ltd on behalf Society Industry (SCI).

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ژورنال

عنوان ژورنال: Journal of Chemical Technology & Biotechnology

سال: 2021

ISSN: ['1097-4660', '0268-2575', '0142-0356', '1935-181X']

DOI: https://doi.org/10.1002/jctb.6920