QIAGEN announced the expansion of its cell and gene therapy (CGT) portfolio with enhanced digital PCR (dPCR) solutions tailored for lentivirus-based applications. These solutions are critical for the production of advanced therapies like chimeric antigen receptor T-cell (CAR-T) immunotherapies. This move strengthens QIAGEN’s role as a trusted partner for quality control in CGT manufacturing, catering to biotech, biopharma companies, and Contract Development and Manufacturing Organizations (CDMOs).
The expansion includes key additions to QIAGEN’s dPCR portfolio, which aim to meet the growing demand for high-precision, scalable solutions to ensure the safety and efficacy of CGT products. The new tools include:
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QIAcuity RCL Quant Kit: This kit detects replication-competent lentivirus (RCL), a significant safety concern in lentiviral vector production, ensuring compliance with regulatory standards and enhancing treatment safety.
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QIAcuity CGT dPCR Assays: These assays, which cover eight wet-lab verified lentiviral targets, are designed for viral vector genome titration and vector copy number determination. They offer superior accuracy and reproducibility, supporting high-throughput workflows for viral titer and genome copy number quantification.
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CGT Lentivirus Lysis Kit: Combined with QIAcuity dPCR assays, this kit improves vector genome titer quantification, enhancing accuracy, repeatability, and efficiency in CGT manufacturing.
These innovations support robust quality control in gene and cell therapy production, ensuring reliable therapeutic outcomes. As the CGT field grows, QIAGEN’s enhanced dPCR solutions offer crucial tools for quality assurance and regulatory compliance, reinforcing its position as a leader in molecular diagnostics for the biopharma industry.