Accelerate Gene Therapy Development and Production Using Laser Force Cytology™
Gene therapy, which delivers DNA into a patient’s cells to replace or add genes that may be abnormal or missing, is starting to deliver results in the clinic after 30+ years of development. With the FDA approving five new gene therapies in 2023, it is truly an exciting time in the field. AAV has proven to be a powerful tool for gene therapy purposes for its broad tropism, inability to replicate on its own in vivo, minimal immunogenicity, and ability to deliver effective and long-lasting results.
There are several challenges related to the development and manufacturing of AAV-based processes, including characterization, quantification, and downstream purification. Manufacturing challenges in particular include the need for the consistent production of high purity, high potency, and robust safety for AAV products, all while maintaining acceptable large-scale manufacturing costs. While there are several methods for AAV production, including transient transfection in human (HEK293) cells, baculovirus driven production in insect (Sf9) cells, or recombinant helper viruses such as HSV in mammalian cells, the importance of precise and predictive analytics remains regardless of the production system.
Radiance®, utilizing the advanced Laser Force Cytology™ (LFC) technology, addresses analytical challenges in gene therapy development. As a Process Analytical Technology (PAT), it serves as an in-process monitoring tool for AAV, adenovirus, and other gene therapy vectors. Offering rapid, label-free single-cell analysis, Radiance® enables real-time data collection for monitoring cell health, transfection, and viral vector production, eliminating the need for time-consuming offline assays. LFC™ proves valuable for AAV transduction measurement, providing a precise and efficient alternative to traditional assays like TCID50 that are often slow, labor-intensive, and challenging to standardize.
Rapid and Label-Free Analysis
LumaCyte’s Radiance® instrument offers rapid speed in analytical processes, accelerating the development timeline and enabling rapid results without the need for labeling.
Radiance® ensures highly precise characterization of cellular properties and changes, enhancing researchers’ ability to understand and optimize therapeutic components, leading to improved overall efficacy and safety profiles.
Comprehensive Single-Cell Insights
The instrument’s capability to provide comprehensive insights at the single-cell level allows researchers to delve deeply into cell heterogeneity, enabling a more nuanced understanding of gene therapy effects and paving the way for personalized and optimized therapeutic strategies.
Improved AAV2 Transduction Analytics Using Laser Force Cytology™
LumaCyte’s Radiance® instrument and Laser Force Cytology™ technology allows for the precise and accurate measurement of AAV transduced cells without relying on a helper virus, accelerating the production of life saving gene therapy products and improving the quality and consistency of key production processes.