QIAGEN Expands Digital PCR Tools for Lentivirus Quality Control
Wednesday, April 30, 2025
QIAGEN has expanded its digital PCR (dPCR) portfolio with new solutions for lentivirus-based applications, which are widely used in the manufacture of advanced treatments such as CAR-T cell therapy a form of personalised cancer immunotherapy.
This development strengthens QIAGEN’s role as a quality control partner in the cell and gene therapy (CGT) sector, supporting biotechnology firms, pharmaceutical manufacturers, contract development and manufacturing organisations (CDMOs), and therapy developers.
The latest additions to the QIAcuity digital PCR workflow aim to provide more precise, scalable, and standardised quality control processes. Key highlights of the new offering include:
- QIAcuity RCL Quant Kit: Designed to detect replication-competent lentivirus (RCL), this kit helps identify trace amounts of RCL a critical safety concern in lentiviral vector production. It follows clear, step-by-step protocols to ensure regulatory compliance and treatment safety.
- QIAcuity CGT dPCR Assays: A set of assays targeting eight lentiviral sequences, enabling accurate titration of viral genomes and vector copy number (VCN) assessment. These assays offer high reproducibility and speed, supporting both singleplex and multiplex workflows.
- CGT Lentivirus Lysis Kit: This kit simplifies vector genome titer quantification, improving accuracy and reducing hands-on time. It is designed for use alongside the QIAcuity CGT dPCR assays, supporting more robust and standardised QC procedures in therapeutic development.
These new additions complement QIAGEN’s existing dPCR tools for CGT, which include kits for residual DNA quantification in HEK293, E. coli, and CHO cell lines, as well as assays for mycoplasma detection, adeno-associated virus (AAV) analysis, viral titer measurement, and vector integrity checks.
As demand for advanced therapies continues to grow, so does the need for reliable quality control methods. Digital PCR, known for its accuracy in absolute quantification, is becoming an essential tool in this space.
QIAGEN’s expanded portfolio, supported by the QIAcuity Software Suite 3.1, is designed to help meet evolving industry and regulatory requirements in CGT manufacturing.
Source: qiagen.com
