The recent regulatory approvals of adeno-associated viral (AAV) and lentiviral (LV) vector-based gene therapies, along with the expanding clinical pipeline for new cell and gene therapies, has created backlogs in manufacturing production.
Immunoassays are commonly used for bioanalysis during vector manufacturing and bioprocess development for titer and empty/full capsid ratios, critical quality attributes (CQAs) for process characterization, and process impurity analysis (also a regulatory requirement related to product safety). Traditional plate-based methods for these analytical characterization steps have numerous drawbacks including long incubation times, narrow dynamic ranges, and multiple manual manipulations, creating workflow bottlenecks in bioanalysis.
Immunoassays have consequently been identified as a target for improvements in analysis speed, accuracy, and sample volume consumption to speed up bioprocess development and manufacturing times, and conserve precious batch samples. In this webinar, we will discuss how advances in bioanalytical assays and technologies have improved immunoassay performance, closing the gap in assay drawbacks for cell and gene therapy manufacturing. Examples from Gyrolab® microfluidic, CD-based immunoassay platform will be presented demonstrating AAV titer, LV titer, and bioprocessing HEK 293 host cell protein impurity analysis improvements.
Through this webinar, attendees will learn about: