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Recently, Waters shared the latest innovations in gene therapy analytical technology with the scientific community at ASGCT 2025. Waters and our Lexeo collaborators led a scientific presentation sharing:

• Advancements in the characterization of megadalton biologics: Essential for cell and gene therapies, tools like size-exclusion chromatography (SEC) for high-resolution analysis improve resolution and reduce non-specific interactions.
• Innovative analytical techniques: Combining SEC with multi-angle light scattering (MALS) and charge detection mass spectrometry (CDMS) provides deeper insights into molecular attributes and rapid, precise characterization of biologics.
• Case studies and applications: Examples were shared, like analysis of Cominarty, Spikevax, mRNA drug substances, lentiviral vectors, and AAV purity investigations, highlighting the practical applications of these advanced techniques.

Sponsored Symposia - Breakthroughs in Gene Therapy Analytics: Potency and Purity-Indicating Assays Using Advanced Size Exclusion Chromatography (SEC) and Charge Detection Mass Spectrometry (CDMS)

Matthew Lauber, Senior Director of Bioseparations, Waters
Noah Miller-Medzon, Downstream Process Development Lead, Lexeo Therapeutics

This talk covered the characterization of megadalton-sized biologics, such as lipid nanoparticle mRNA, plasmids, capsids, and viral vectors, which are vital for cell and gene therapy development and testing. SEC is highlighted as a key method for separating these complex modalities, with innovations in SEC column technology enhancing resolution and reducing non-specific interactions. CDMS, particularly in compact benchtop systems, provides rapid and precise characterization of biologics, including detailed analysis of AAV vectors.

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