To achieve quality by design in biopharmaceutical production, manufacturers need tools that can ensure the stability of critical process parameters (CPPs) and other performance indicators related to product critical quality attributes (CQAs). Over the past couple of decades, sophisticated process analytical technologies (PATs) have emerged to address such needs. Offerings are now abounding for single-purpose sensors that measure temperature, pressure, pH, glucose, protein concentration, or dissolved oxygen. New in-line formats are enabling such instruments to provide data in real time, bringing manufacturers of monoclonal antibodies and other protein products closer than ever before to the goal of adaptive process control. But much work remains to be done regarding process analytics for cell therapies and other emerging biopharmaceutical modalities.
This eBook maps out the current PAT landscape, gauging remaining needs for modern biopharmaceutical workflows. BPI’s associate editor speaks with the founders of Andson Biotech, a newly launched PAT developer, to learn why commercially available sensors and other PATs suffice for many conventional upstream processes but not for production of complex proteins or advanced therapies. The discussion emphasizes developers’ needs for tools that can monitor more specific parameters, which in turn could provide more meaningful information about process and product quality. Read the eBook to learn about such needs and about emerging solutions such as Andson Biotech’s technologies for real-time mass spectrometric analysis of biomolecules.
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