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  • Abstract
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  • Authors

Company Biography

Analytical regulatory requirements for AAV-based gene therapies are currently not well established. However, monitoring protein and ssDNA heterogeneity for AAV may help define regulated analytics and accelerate AAV clinical and process development. Considerations in developing analytics for AAV include low concentrations, limited quantities, and large analyte masses that challenge commercially available analytical techniques. Here, we present methods for LC-TOF-MS analysis of both trypsin digested AAV5 and intact capsid proteins of several AAV serotypes. We also demonstrate the utility of charge-detection MS (CDMS) to analyze ssDNA isolated from AAV9 by anion-exchange chromatography (AEC). Additionally, CDMS, AEC, and size-exclusion chromatography measurements of the level of AAV8 without its targeted complement ssDNA are compared.

Contact Information

Name
Ying Qing Yu

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Team Members

Ying Qing Yu profile image

Ying Qing Yu

Waters Corporation

Presenter
Ying Qing Yu
Waters Corporation
Email: ying_qing_yu@waters.com
Benjamin Draper profile image

Benjamin Draper

Megadalton solutions

Co-Author
Benjamin Draper
Megadalton solutions
Email: bdraper@megadaltonsolutions.com
Hua Yang profile image

Hua Yang

Waters Corporation

Co-Author
Hua Yang
Waters Corporation
Email: Hua_yang@waters.com
Zichuan (Zack) Zhang profile image

Zichuan (Zack) Zhang

Sanofi

Co-Author
Zichuan (Zack) Zhang
Sanofi
Email: zack.zhang@sanofi.com
Lin Liu profile image

Lin Liu

Sanofi

Co-Author
Lin Liu
Sanofi
Email: lin.liu@sanofi.com
Stephan Koza profile image

Stephan Koza

Waters Corporation

Co-Author
Stephan Koza
Waters Corporation
Email: stephan_koza@waters.com
Weibin Chen profile image

Weibin Chen

Waters Corporation

Co-Author
Weibin Chen
Waters Corporation
Email: weibin_chen@waters.com
Xiaoying Jin profile image

Xiaoying Jin

Sanofi

Co-Author
Xiaoying Jin
Sanofi
Email: xiaoying.jin@genzyme.com