What should next-generation analytical platforms for biopharmaceutical production look like?

• Published in: Trends in biotechnology (Regular ed.) 2024-03, Vol.42 (3), p.282-292
• Main Authors: Rathore, Anurag S., Sarin, Deepika
• Format: Article
• Language: English
• Subjects: Antibodies, Monoclonal; Artificial intelligence; Automation; Biological Products; Biopharmaceuticals; Chromatography; Data analysis; data analytics; Fourier transforms; Industry 4.0; machine learning; Manufacturers; Manufacturing; Mathematical analysis; Monitoring; Monoclonal antibodies; multiattribute monitoring; Pharmaceutical industry; Platforms; Process controls; Quality management; real-time monitoring; Reproducibility; spectroscopy
• ISSN: 0167-7799; 1879-3096
• DOI: 10.1016/j.tibtech.2023.08.008

The current analytical platform for biotherapeutic characterization is expensive and needs revamping with increased online testing and use of advanced data analytics.Advances in spectroscopic tools and applications have improved online monitoring of process variables in upstream and downstream processes.Multi-attribute monitoring with mass spectrometry has the potential to match spectroscopic advancement for online monitoring of biotherapeutic critical quality attributes.Novel applications in next-generation analytical platforms for biotherapeutics will be fueled by integration of advanced data analytics and machine learning with existing analytical tools. Biotherapeutic products, particularly complex products such as monoclonal antibodies (mAbs), have as many as 20–30 critical quality attributes (CQAs), thereby requiring a collection of orthogonal, high-resolution analytical tools for characterization and making characterization a resource-intensive task. As discussed in this Opinion, the need to reduce the cost of developing biotherapeutic products and the need to adopt Industry 4.0 and eventually Industry 5.0 paradigms are driving a reappraisal of existing analytical platforms. Next-generation platforms will have reduced offline testing, renewed focus on online testing and real-time monitoring, multiattribute monitoring, and extensive use of advanced data analytics and automation. They will be more complex, more sensitive, resource lean, and more responsive compared with existing platforms. Biotherapeutic products, particularly complex products such as monoclonal antibodies (mAbs), have as many as 20–30 critical quality attributes (CQAs), thereby requiring a collection of orthogonal, high-resolution analytical tools for characterization and making characterization a resource-intensive task. As discussed in this Opinion, the need to reduce the cost of developing biotherapeutic products and the need to adopt Industry 4.0 and eventually Industry 5.0 paradigms are driving a reappraisal of existing analytical platforms. Next-generation platforms will have reduced offline testing, renewed focus on online testing and real-time monitoring, multiattribute monitoring, and extensive use of advanced data analytics and automation. They will be more complex, more sensitive, resource lean, and more responsive compared with existing platforms.