Lentiviral quantification
Gene modification plays a vital role in numerous cell therapy workflows, such as CAR-T therapies. Lentiviral vectors are currently utilized as highly efficient vehicles for transgene delivery. Given the significant impact of the cell therapy production process on the final product, meticulous control of physical and infectious titers is crucial for efficient development and enhanced product safety.
Monitor titers with accuracy and precision
Whether produced in-house or via a manufacturing partner, accurate measurement and control of lentiviral titers plays a pivotal role in cell therapy development. By maintaining tight control over lentiviral titers, cell therapy manufacturers can achieve faster process optimization and streamline lot release testing, thus enhancing the efficiency and safety of their products.
Regulatory agencies like the FDA and EMA have stringent guidelines for vector copy number (VCN) in cell therapy. Manufacturers must demonstrate that their processes can control VCN and that their final products are safe for use. This involves rigorous optimization during development and scalable solutions for release testing.
Applied Biosystems ViralSEQ Lentivirus Titer solutions for cell therapies
The ViralSEQ lentiviral quantitation system offers a portfolio of real-time and digital PCR assay kits to measure the physical and proviral titer of lentiviral vectors used for genetic modification in cell therapies.
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