LumaCyte, an advanced bioanalytical instrumentation company has demonstrated a significant advancement using its transformative Laser Force Cytology (LFC) instrument, Radiance®. LumaCyte recently collaborated with global cell and gene therapy leader, Catalent, where their joint teams uncovered valuable new capabilities in the monitoring of adeno-associated virus (AAV) production and infectivity, foundational precursors in the production of gene therapy products. In a subset of the work completed, it was found that Radiance® provided important insights into optimal transfectant selection in a fraction of the time and effort when compared to ddPCR. These results, which correlated tightly with the ddPCR titer results, have recently been published by the organizations in a joint technical note.
Gene therapy development and production is incredibly complex, where different cell lines and viral vectors can be used across the treatment manufacturing process. Commonly used viral vectors in gene therapy are AAV, retrovirus, and lentivirus, which do not induce cytopathic effect in cells thus making them impossible to titer using traditional TCID50 and plaque assay methods. Genetic methods such as ddPCR are commonly used to assess the production of gene therapy treatments, but results are slow and require significant skilled labor. By contrast, Radiance® provides developers results in minutes post-harvest with a simple sample dilution. LumaCyte’s label-free LFC technology yields a wealth of data, delivering deep insights into cellular conditions which are incredibly valuable in the monitoring of production quality, including cell health and potential contamination, in addition to viral titer. “Bringing together the unique biophysical and biochemical cellular interactions using laser forces on single cells, along with advanced computation of multivariate data now allows us to uncover a mine of infection and transfection metrics not previously attainable,” says Bhargavi Kondragunta, Director, Internal Process Development & Research at Catalent Cell & Gene Therapy.
With the increasing intricacy of gene therapy production, and a diversity of development options, it is vital for developers and researchers to have a robust understanding of the data at each step throughout their process. This increased knowledge requirement has forced biopharma development and manufacturing partners, including Contract Development and Manufacturing Organizations (CDMOs), to seek out novel analytical tools and approaches that can provide real-time analysis capability across their processes, ultimately enabling acceleration of the production of these lifesaving treatments. “Being able to rapidly optimize the gene therapy production process allows developers to proceed to scale with the knowledge that each step of their process has been accurately completed is paramount to a successful commercialization strategy and ensuring these treatments can be delivered at a broad scale,” says Renee Hart, President and CBO at LumaCyte. Catalent and LumaCyte are exploring the wide range of applications that Laser Force Cytology can offer the highly complex gene therapy development and manufacturing industry. This new rapid label-free analytical capability offers real-time product quality monitoring in a fraction of the time ensuring safe and efficacious treatments are produced at incredible efficiency.
LumaCyte is an advanced research and bioanalytics instrumentation company that produces label-free, single cell analysis and sorting instrumentation where the use of antibody or genetic labeling is not required for cellular analysis. This revolutionary technology utilizes Laser Force Cytology™ (LFC™) to measure optical and fluidic forces within a microfluidic channel to identify and measure intrinsic biophysical and biochemical properties of single cells. The multivariate nature of the data has enabled a host of Big Data strategies and cloud computing capabilities that drive advanced analytics, allowing a deeper understanding of cell based biological systems. Applications of LumaCyte’s label-free platform technology include viral infectivity for vaccine development and manufacturing, cell and gene therapy development and production monitoring, cancer biology R&D, CAR T-cell immunotherapy, iPSCs, infectious disease, and pre-clinical drug discovery, in addition to multiple applications across the biomanufacturing sector focused on quality control (AAT) and process optimization.
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Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 13,500 people, including approximately 2,400 scientists and technicians, at more than 40 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com
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