QIAGEN Expands Digital PCR Portfolio With Advanced Lentivirus Solutions to Elevate Quality Control in Cell and Gene Therapy Manufacturing
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA), a global leader in sample and assay technologies for molecular diagnostics and life sciences, has announced a significant expansion of its digital PCR (dPCR) portfolio tailored specifically for the fast-growing cell and gene therapy (CGT) sector. The new solutions are designed to enhance quality control workflows in the production of lentivirus-based therapies, including chimeric antigen receptor T-cell (CAR-T) treatments, a groundbreaking form of personalized cancer immunotherapy.
This strategic enhancement to QIAGEN’s CGT offering includes a suite of high-precision digital PCR tools optimized for lentiviral vector characterization and detection, positioning the company as a trusted quality control partner for biopharmaceutical companies, Contract Development and Manufacturing Organizations (CDMOs), and therapy developers focused on next-generation treatments.
Meeting the Growing Demands of Cell and Gene Therapy Manufacturing
As the cell and gene therapy landscape rapidly evolves to address complex and previously untreatable diseases such as various forms of cancer, genetic disorders, and rare conditions, the demand for robust and scalable quality control solutions has intensified. Ensuring the consistency, safety, and efficacy of CGT products—many of which are personalized for individual patients—requires highly accurate and reproducible analytical tools.
“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.”
Comprehensive Digital PCR Solutions for Lentiviral Applications
Lentiviral vectors are essential vehicles for delivering genetic material into cells during the manufacturing of CAR-T and other CGT products. However, their use also brings stringent safety and efficacy requirements, making accurate quality control a critical part of the development and production pipeline.
To address these needs, QIAGEN has introduced several new digital PCR assays and tools to strengthen lentiviral quality control:
1. QIAcuity RCL Quant Kit
This new kit is specifically designed for the detection of replication-competent lentivirus (RCL), a serious safety concern in CGT manufacturing. Even trace amounts of RCL must be identified and eliminated to ensure patient safety and compliance with regulatory standards. The QIAcuity RCL Quant Kit offers a highly sensitive, easy-to-use workflow with step-by-step protocols that enable users to detect minimal quantities of RCL with confidence. Its accuracy is essential in meeting the rigorous requirements of global health authorities.
2. QIAcuity CGT dPCR Assays for Lentiviral Vectors
QIAGEN has also introduced a new set of QIAcuity CGT digital PCR assays, featuring eight wet-lab validated targets specific to lentiviral vector quantification. These assays are designed for two primary applications:
- Vector Genome Titration – Measuring the number of viral genome copies present in a sample.
- Vector Copy Number (VCN) Determination – Calculating how many copies of the therapeutic gene are integrated into the genome of target cells.
These assays offer superior performance in terms of accuracy, reproducibility, and turnaround time. They are optimized for use with QIAGEN’s QIAcuity Digital PCR System, supporting both singleplex and multiplex applications for high-throughput workflows—critical in both development and manufacturing environments.
3. CGT Lentivirus Lysis Kit and Protocol
To further simplify and standardize the lentiviral titer quantification process, QIAGEN is launching the CGT Lentivirus Lysis Kit. Used in combination with the QIAcuity CGT dPCR assays, this kit minimizes manual steps, enhances precision, and improves repeatability. It enables efficient and reproducible quantification of viral genome titers from lentivirus particles and is ideal for CGT applications where reliability and scalability are paramount.
These combined solutions help streamline biopharmaceutical manufacturing processes, support regulatory compliance, and contribute to faster and safer delivery of advanced therapies to patients.
Integration With Broader CGT Workflow Solutions
The newly released assays and kits join QIAGEN’s growing portfolio of digital PCR tools designed specifically for the needs of the biopharmaceutical and biotechnology sectors. In addition to lentivirus-focused solutions, QIAGEN’s CGT assay offerings include:
- Residual DNA Quantification Kits – For widely used production cell lines such as HEK293, E. coli, and CHO cells, ensuring purification processes effectively remove host cell DNA.
- Mycoplasma Detection Kits – Enabling rapid screening for mycoplasma contamination, a key requirement in CGT and biologics production.
- Adeno-Associated Virus (AAV) Applications – Including assays for AAV titer and genome integrity, widely used in gene therapy.
- Viral Vector Integrity Assays – Ensuring the structure and function of viral vectors are maintained throughout manufacturing and storage.
All assays are compatible with QIAcuity’s nanoplates and master mixes, delivering absolute quantification and streamlined workflows to CGT developers and manufacturers.
Digital PCR: A Preferred Tool for Regulatory Compliance
Digital PCR has emerged as a preferred analytical technology in advanced therapy manufacturing due to its ability to deliver absolute quantification without the need for external standards. It enables more accurate, reproducible, and sensitive measurements than traditional qPCR, making it ideal for applications requiring high precision, such as gene therapy development and biologics QC.
QIAGEN’s QIAcuity Digital PCR System, powered by the latest QIAcuity Software Suite 3.1, provides an integrated platform for dPCR analysis that is aligned with industry standards and regulatory guidelines. The system offers intuitive workflows, data integrity features, audit trails, and robust reporting to meet the compliance needs of regulated CGT environments.
A Long-Term Commitment to Innovation in CGT
The cell and gene therapy market continues to experience robust growth, with a pipeline of innovative therapies under development and increasing investment from both public and private sectors. As of 2025, more than 2,000 CGT clinical trials are underway worldwide, underscoring the need for scalable manufacturing solutions that support consistent quality and safety.
QIAGEN is committed to supporting this evolution by delivering end-to-end solutions that help researchers and manufacturers optimize their workflows and accelerate time to market. The company’s latest lentivirus-focused offerings underscore this mission, helping industry stakeholders meet complex scientific and regulatory challenges head-on.
“We believe the future of medicine is being reshaped by cell and gene therapies, and we are proud to play a key role in enabling their success,” added Krause-Harder. “By expanding our digital PCR portfolio and deepening our capabilities in lentiviral vector analysis, we aim to help our partners bring safer, more effective therapies to patients faster and more efficiently.”
QIAGEN is a leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from biological samples. The company’s technologies and products serve more than 500,000 customers across the life sciences and molecular diagnostics industries. With operations in over 25 countries and a portfolio that spans from sample preparation to advanced bioinformatics, QIAGEN continues to drive innovation in precision medicine, disease detection, and therapy development.
