QIAGEN has expanded its cell and gene therapy (CGT) portfolio with an enhanced digital PCR (dPCR) workflow that includes solutions for lentivirus-based applications, commonly used in the production of advanced treatments such as chimeric antigen receptor T-cell (CAR-T), a personalized form of cancer immunotherapy. 

These new solutions join the growing portfolio of cell and gene therapy dPCR assays for the biopharma market, including residual DNA quantification kits for commonly used production cell lines such as Human Embryonic Kidney 293 (HEK293), E. coli, and Chinese Hamster Ovary (CHO) cells, mycoplasma quantification kit, adeno-associated virus (AAV) application, viral titer assays and solutions to determine viral vector integrity.

This expansion supports standardized, high-precision quality control workflows and supports biotech and biopharma companies, CDMO, and therapy developers in CGT manufacturing.

New solutions include:

• QIAcuity RCL Quant Kit that detects replication-competent lentivirus (RCL), a key safety concern in lentiviral vector production. The kit uses clear step-by-step protocols to find even small amounts of RCL, helping therapy developers meet regulations and keep treatments safe.
• New QIAcuity CGT dPCR assays, including eight different wet-lab verified lentiviral targets, are designed for viral vector genome titration (measuring the amount of therapeutic virus particles) and vector copy number (VCN) determination (counting how many copies of a gene are inserted into each cell). The assays offer superior accuracy, reproducibility, and speed on the QIAcuity Digital PCR System and enable singleplex and multiplex applications for a streamlined, high-throughput workflow.
• New CGT Lentivirus Lysis Kit and protocol, combined with QIAcuity CGT dPCR assays, which enable vector genome titer quantification with fewer hands-on steps, enhanced accuracy, and repeatability. It supports standardized titer quantification from lentivirus particles, promotes robust QC and improved operating procedures, and is ideal for drug development and manufacturing in CGT.

“Cell and gene therapy developers face increasing demands for precise, scalable solutions to help ensure therapy safety and efficacy,” said Justus Krause-Harder, Vice President and Head of Molecular Tools & Oncology at QIAGEN. “With our expanded dPCR portfolio, we are not only meeting the needs of lentivirus-based therapies but also reaffirming our long-term commitment as a partner for quality control in CGT development and manufacturing.”