NanoMosaic launches AAV gene therapy bioprocessing and manufacturing QC assays for simultaneous capsid & transgene interrogation with high standardization

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Mar 06, 2024, 07:00 ET

WALTHAM, Mass., March 6, 2024 /PRNewswire/ -- NanoMosaic, the multiplex and multi-omic quantification company, today announced the expanded capabilities and availability of assays optimized on its Tessie™ system for use in gene therapy applications. The platform combines the ability to quantify proteins and nucleic acids in a single run, enabling the simultaneous detection and characterization of adeno-associated virus (AAV) capsids and of therapeutic transgenes.

New data from NanoMosaic include characterization and quantification of full, empty, partial, and internally deleted transgenes directly from crude extracts, providing researchers with the unique ability to accurately quantify the full and intact transgene throughout the bioprocessing and manufacturing of AAV therapies. The assays are seamlessly deployable across upstream and downstream stages of the gene therapy workflow, while harmonizing the data from bioprocessing to batch release QC.

"Efficacy and patient safety are always top of mind in gene therapy," says Sylvain Cecchini, PhD, associate professor of microbiology & physiological systems and director of the AAV Large Scale Manufacturing Facility Core at UMass Chan Medical School. "The objectives pursued by NanoMosaic are positive steps forward for a space desperate for a fit-for-purpose tool that can be standardized throughout the entire gene therapy development and manufacturing processes. The ability to better characterize full and intact transgenes can result in more positive patient outcomes with fewer side effects and lower chances for immunogenicity".

The Tessie platform consists of a 96- or 384-well SBS-compatible plate consumable, a fully-automated plate reader, and data analysis software that can be integrated with conventional laboratory automation. At the heart of the technology are MosaicNeedles™, an array of label-free nanoscale biosensors and a simple and familiar ELISA-like workflow to produce millions of individual data points for analysis. The result is a label-free, multi-omic platform for the simultaneous quantification of AAV capsid proteins and characterization of full-length transgenes, in a single, less-than 3-hour workflow using crude samples.

AAV preparations remain highly heterogeneous through bioprocessing phases. Characterizing empty, partial, full, overfilled capsids and encapsulated host cell DNA are essential for proper dosing, patient safety, and manufacturing consistency. Analytical methods currently deployed throughout the upstream and downstream gene therapy processes are numerous and lack harmonization which can misrepresent the true therapeutic payload. NanoMosaic's Tessie brings this down to just one platform, drastically standardizing the data measured across the manufacturing workflow while improving throughput and accelerating time-to-market.

"NanoMosaic is excited to offer a unique solution to a challenging and fast-growing gene therapy market," said Qimin Quan, PhD, co-founder and Chief Scientific Officer. "In addition to AAV characterization applications, we remain committed to empowering the scientific community with high-plex and multi-omic solutions for biomarker research and diagnostics," Quan added.

NanoMosaic will feature the platform and unique gene therapy applications in a live broadcast scientific webinar alongside industry leaders on March 26, 2024, hosted by Genetic Engineering News (GEN).

About NanoMosaic

NanoMosaic is a pioneering biotechnology company that develops innovative tools and technologies for biomarker detection and analysis. The company's flagship product, the NanoMosaic Tessie™ system, is a high-throughput platform for protein biomarker detection that enables researchers to analyze multiple samples simultaneously with high sensitivity and specificity across proteins and nucleic acid on the same run. The system is designed to accelerate the discovery and development of biomarkers for a wide range of applications, including disease diagnosis, drug discovery, and precision medicine. For more information about NanoMosaic, please visit their website at www.nanomosaicllc.com.

CONTACT: Joe Wilkinson, [email protected]

SOURCE NanoMosaic