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Process Analytical Technologies and Data Analytics for the Manufacture of Monoclonal Antibodies
| Content Provider | Scilit |
|---|---|
| Author | Maruthamuthu, Murali K. Rudge, Scott R. Ardekani, Arezoo M. Ladisch, Michael R. Verma, Mohit S. |
| Copyright Year | 2020 |
| Description | Journal: Trends in Biotechnology 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. |
| Related Links | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7442002/pdf http://www.cell.com/article/S0167779920301852/pdf |
| Ending Page | 1186 |
| Page Count | 18 |
| Starting Page | 1169 |
| ISSN | 01677799 |
| e-ISSN | 18793096 |
| DOI | 10.1016/j.tibtech.2020.07.004 |
| Journal | Trends in Biotechnology |
| Issue Number | 10 |
| Volume Number | 38 |
| Language | English |
| Publisher | Elsevier BV |
| Publisher Date | 2020-08-21 |
| Access Restriction | Open |
| Subject Keyword | Journal: Trends in Biotechnology Analytical Chemistry Continuous Manufacturing Monoclonal Antibodies Process Analytical Technology |
| Content Type | Text |
| Resource Type | Article |
| Subject | Bioengineering Biotechnology |
