Online/At-line Monitoring of Product Titer & Critical Product Quality Attributes (CQAs) During Process Development

Abstract

Process analytical technology (PAT) has been defined by the Food and Drug Administration (FDA) as a system for designing, analyzing, and controlling manufacturing through timely measurements to ensure final product quality. Based on qualityby-design (QbD) principles, real-time data monitoring is essential for timely control of critical quality attributes (CQAs) to keep the process in a state of control. To facilitate next-generation continuous bioprocessing, deployment of PAT tools for

Perspective Chapter: Advanced Process Control and Automation with Special Focus on Emerging Continuous Bioprocessing

“…Since the upstream samples require purification prior to product quality assessment, the 1st dimension of 2D-LC is leveraged for protein purification while the 2nd dimension is utilized for product quality assessment [19]. A UPLC system with PSM autosampler is better suited for upstream titer measurement and downstream product quality measurements [20]. The same UPLC system with PSM autosampler can facilitate online purity assessment during peak pooling [21].…”

Advances in bioreactor control for production of biotherapeutic products

“…literature . In other related studies, applications of off-gas analysis using magnetic sector mass spectrometer (Goh et al, 2020), 2D LC (Chemmalil et al, 2021) (discussed as Illustration 4), and on-line UPLC (Chemmalil et al, 2020) have been successfully attempted. Another major advancement in regard to PAT implementation is the development of miniaturized PAT tools (Rowland-Jones et al, 2021;Read et al, 2010a).…”