Publications by authors named "Shailin K Patel"
Article Synopsis
- * A new denaturing size-exclusion chromatography (dSEC) method was developed, optimizing various parameters to achieve better separation of AAV viral proteins (VP(1-3)) across multiple serotypes.
- * The optimized dSEC-MS method was validated through case studies, demonstrating its capability for analyzing AAV production processes and enhancing quality control for AAV-based gene therapies.
To support adeno-associated virus (AAV)-based gene therapy development, characterization of the three capsid viral proteins (VP; VP1/VP2/VP3) from recombinant AAV can offer insights on capsid identity, heterogeneity, and product and process consistency. Intact protein mass analysis is a rapid, reliable, and sensitive method to confirm AAV serotypes based on accurate mass measurement of the constituent capsid proteins. Compared to commonly applied reversed-phase liquid chromatography (RPLC) methods, we demonstrated that, using a wide-pore amide-bonded column, hydrophilic interaction chromatography (HILIC) could achieve improved separation of VPs from a variety of AAV serotypes using a generic method prior to MS detection.
View Article and Find Full Text PDF