Academic Journal
Interest of locally weighted regression to overcome nonlinear effects during in situ NIR monitoring of CHO cell culture parameters and antibody glycosylation
| العنوان: | Interest of locally weighted regression to overcome nonlinear effects during in situ NIR monitoring of CHO cell culture parameters and antibody glycosylation |
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| المؤلفون: | Zavala‐ortiz, Daniel, Ebel, Bruno, Li, Meng‐yao, Barradas‐dermitz, Dulce Ma., Hayward‐jones, Patricia, Aguilar‐uscanga, Maria, Marc, Annie, Guedon, Emmanuel |
| المساهمون: | Laboratoire Réactions et Génie des Procédés (LRGP), Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Instituto Tecnologico de Veracruz, Instituto Tecnológico de Veracruz, ANR-17-CE18-0012,ProCell-In-line,Capteurs logiciels innovants pour le suivi en-ligne de procédés de culture de cellules animales(2017) |
| المصدر: | ISSN: 8756-7938 ; Biotechnology Progress ; https://hal.univ-lorraine.fr/hal-02333228 ; Biotechnology Progress, 2020, 36 (e2924), pp.1-10. ⟨10.1002/btpr.2924⟩. |
| بيانات النشر: | HAL CCSD Wiley |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | [SPI.GPROC]Engineering Sciences [physics]/Chemical and Process Engineering, [SDV.BIO]Life Sciences [q-bio]/Biotechnology |
| الوصف: | International audience ; Animal cell culture processes have become the standard platform to produce therapeutic proteins such as recombinant monoclonal antibodies (mAb). Since the mAb quality could be subject to significant changes depending on manufacturing process conditions, real time monitoring and control systems are required to ensure mAb specifications mainly glycosylation and patient safety. Up to now, real time monitoring glycosylation of proteins has received scarce attention. In this article, the use of near infrared (NIR) to monitor mAb glycosylation has been reported for the first time. Whereas monitoring models are mainly constructed using linear partial least squares regressions (PLSR), evidences presented in this study indicate nonlinearity relationship between in situ captured spectra and compound concentrations, compromising the PLSR performances. A novel and simple approach was proposed to fit non-linearity using the locally weighted regression (LWR). The LWR models were found to be more appropriate for handling information contained in spectra so that real time monitoring of cultures were accurately performed. Moreover, for the first time, the LWR calibration models allowed mAb glycosylation to be monitored, in a real time manner, by using in situ NIR spectroscopy. These results represent a further step toward developing active-control feedback of animal cell processes, particularly for ensuring properties of biologics. K E Y W O R D S in situ near infrared spectroscopy, locally weighted regression-LWR, monoclonal antibody-mAb glycosylation, partial least squares regression-PLSR, real time monitoring 1 | INTRODUCTION The production of biologicals, especially recombinant monoclonal anti-bodies (mAb), remains a challenge due to the structural complexity of these molecules and their sensitivity to changes in the manufacturing process. That is why strict quality control systems are required to ensure mAb specifications and patient safety. For that, regulatory agencies proposed the quality by ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1002/btpr.2924 |
| الاتاحة: | https://hal.univ-lorraine.fr/hal-02333228 https://hal.univ-lorraine.fr/hal-02333228v1/document https://hal.univ-lorraine.fr/hal-02333228v1/file/Biotech%20Prog-LWR-2020.pdf https://doi.org/10.1002/btpr.2924 |
| Rights: | http://creativecommons.org/licenses/by/ ; info:eu-repo/semantics/OpenAccess |
| رقم الانضمام: | edsbas.F005FCE7 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1002/btpr.2924 |
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