Process Analytical Technologies and Data Analytics for the Manufacture of Monoclonal Antibodies
| Autor: | Arezoo M. Ardekani, Mohit S. Verma, Murali Kannan Maruthamuthu, Michael R. Ladisch, Scott R. Rudge |
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| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
2019-20 coronavirus outbreak spectroscopy Computer science medicine.drug_class Process (engineering) Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Process analytical technology Cell Culture Techniques Bioengineering 02 engineering and technology CHO Cells Monoclonal antibody sensors Article spectrometry 03 medical and health sciences Bioreactors Cricetulus Cricetinae medicine Animals Humans Technology Pharmaceutical continuous manufacturing Potential impact Antibodies Monoclonal Computational Biology 021001 nanoscience & nanotechnology process analytical technology 030104 developmental biology Data analysis Biochemical engineering monoclonal antibodies 0210 nano-technology Drug Contamination Mycoplasma contamination Biotechnology |
| Zdroj: | Trends in Biotechnology |
| ISSN: | 1879-3096 |
| Popis: | Process analytical technology (PAT) for the manufacture of monoclonal antibodies (mAbs) is defined by an integrated set of advanced and automated methods that analyze the compositions and biophysical properties of cell culture fluids, cell-free product streams, and biotherapeutic molecules that are ultimately formulated into concentrated products. In-line or near-line probes and systems are remarkably well developed, although challenges remain in the determination of the absence of viral loads, detecting microbial or mycoplasma contamination, and applying data-driven deep learning to process monitoring and soft sensors. In this review, we address the current status of PAT for both batch and continuous processing steps and discuss its potential impact on facilitating the continuous manufacture of biotherapeutics. Highlights Process analytical technology (PAT) has evolved from hardware-based analyses for defined biological, biomolecular, and biochemical analytes to a toolbox that encompasses data analytics and soft sensors to monitor and control monoclonal antibody (mAb) manufacture. Engineered cell lines used in batch processes and continuous manufacturing have helped improve qualities and production rates for mAbs. Data analytics has become increasingly important as sensors become smaller, more robust, and increasingly ubiquitous, with soft sensors enabling determination of a rolling baseline of process conditions and consequences during the production of biologics. In-line sensors utilized for downstream processes provide a template for how such sensors might be used as part of PAT in the real-time monitoring of the manufacture of biotherapeutic proteins in both upstream and downstream unit operations. |
| Databáze: | OpenAIRE |
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