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Nanomosaic Unveils AAV Gene Therapy Bioprocessing and Manufacturing QC Assays Enabling Simultaneous Examination of Capsid and Transgene, Ensuring Heightened Standardization

Thursday, March 07, 2024

NanoMosaic, a company specializing in multiplex and multi-omic quantification, has unveiled significant advancements in its Tessie™ system tailored for gene therapy applications. This innovative platform allows for the simultaneous quantification and characterization of adeno-associated virus (AAV) capsids and therapeutic transgenes, streamlining crucial processes in gene therapy development.

The latest findings from NanoMosaic demonstrate the capability to characterize and quantify various forms of transgenes directly from crude extracts. This includes full, empty, partial, and internally deleted transgenes, providing researchers with precise insights throughout the bioprocessing and manufacturing stages of AAV therapies. These assays integrate seamlessly into the gene therapy workflow, ensuring consistent data from bioprocessing to batch release quality control.

According to Sylvain Cecchini, PhD, Associate Professor at UMass Chan Medical School, NanoMosaic's advancements are crucial for ensuring efficacy and patient safety in gene therapy. The ability to accurately characterize transgenes can lead to improved patient outcomes with reduced side effects and lower risks of immunogenicity.

The Tessie platform comprises a 96- or 384-well SBS-compatible plate consumable, a fully-automated plate reader, and integrated data analysis software. Central to this technology are MosaicNeedles™, label-free nanoscale biosensors, and an intuitive ELISA-like workflow, enabling millions of data points for analysis in less than three hours using crude samples.

In gene therapy, AAV preparations exhibit high heterogeneity throughout bioprocessing. Accurate characterization of capsids and encapsulated DNA is crucial for dosing, patient safety, and manufacturing consistency. NanoMosaic's Tessie platform consolidates multiple analytical methods into one, standardizing data across the manufacturing workflow while enhancing throughput and accelerating time-to-market.

Qimin Quan, PhD, Co-founder and Chief Scientific Officer of NanoMosaic, expressed excitement about the unique solution offered to the gene therapy market. Beyond AAV characterization, NanoMosaic remains dedicated to providing high-plex and multi-omic solutions for biomarker research and diagnostics.

To showcase these advancements, NanoMosaic will host a live broadcast scientific webinar on March 26, 2024, in collaboration with industry leaders, presented by Genetic Engineering News (GEN).



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