QIAGEN Expands Its Digital PCR Portfolio With New Lentivirus Solutions to Strengthen Cell and Gene Therapy Quality Control

• QIAcuity digital PCR kits, assays and protocols for lentivirus-based therapies support quality control in cell and gene therapy manufacturing

• Expansion underscores the commitment of QIAGEN to help accelerate the development of safe and effective biotherapeutics

• New solutions support high-precision analytics for process development, batch release and regulatory compliance and enable a standardized workflow

QIAGEN (NYSE:QGEN, Frankfurt Prime Standard: QIA)) today announced the expansion of its cell and gene therapy (CGT) portfolio with an enhanced digital PCR (dPCR) workflow that now 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.

This expanded offering supports standardized, high-precision quality control (QC) workflows and strengthens the position of QIAGEN as a trusted partner for quality control, supporting biotech and biopharma companies, Contract Development and Manufacturing Organizations (CDMO) and therapy developers in CGT manufacturing.

"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."

The additions to QIAGEN's offering of dPCR solutions for lentiviral vectors and their characterization include:

• The QIAcuity RCL Quant Kit 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.

• The 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.
  
  
  
  Together with QIAcuity nanoplates and dedicated master mixes, these assays deliver absolute quantification of viral titer (the concentration of virus particles in a sample) and vector copy number determination, which are crucial for biopharmaceutical manufacturing and quality control processes.

• The new CGT Lentivirus Lysis Kit and protocol, combined with QIAcuity CGT dPCR assays, enables 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.

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.

As cell and gene therapies evolve to offer new treatment options for cancer, genetic diseases and other conditions, reliable quality control is essential to help ensure patient safety and therapeutic effectiveness. Therefore, dPCR has become a preferred analytical tool due to its accurate quantification ability, coupled with the QIAcuity Software Suite 3.1, ensuring regulatory compliance. QIAGEN is well-positioned to support the industry's growth and evolving regulatory demands.

For more information on QIAGEN's offering for cell and gene therapies, please visit https://www.qiagen.com/us/applications/pharma-biotech/cell-and-gene-therapy.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions, enabling customers to extract and gain valuable molecular insights from samples containing the building blocks of life. Our Sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies prepare these biomolecules for analysis while bioinformatics software and knowledge bases can be used to interpret data to find actionable insights. Automation solutions bring these processes together into seamless and cost-effective workflows. QIAGEN serves over 500,000 customers globally in Life Sciences (academia, pharma R&D and industrial applications, primarily forensics) and Molecular Diagnostics for clinical healthcare. As of December 31, 2024, QIAGEN employed more than 5,700 people in over 35 locations worldwide. For more information, visit www.qiagen.com.

Forward-Looking Statement

Certain statements in this press release may constitute forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. These statements, including those regarding QIAGEN's products, development timelines, marketing and / or regulatory approvals, financial and operational outlook, growth strategies, collaborations and operating results - such as expected adjusted net sales and adjusted diluted earnings - are based on current expectations and assumptions. However, they involve uncertainties and risks. These risks include, but are not limited to, challenges in managing growth and international operations (including the effects of currency fluctuations, regulatory processes and logistical dependencies), variability in operating results and allocations between customer classes, commercial development for our products to customers in the Life Sciences and clinical healthcare, changes in relationships with customers, suppliers or strategic partners; competition and rapid technological advancements; fluctuating demand for QIAGEN's products due to factors such as economic conditions, customer budgets and funding cycles; obtaining and maintaining regulatory approvals for our products; difficulties in successfully adapting QIAGEN's products into integrated solutions and producing these products; and protecting product differentiation from competitors. Additional uncertainties may arise from market acceptance of new products, integration of acquisitions, governmental actions, global or regional economic developments, natural disasters, political or public health crises, and other "force majeure" events. There is also no guarantee that anticipated benefits from acquisitions will materialize as expected. For a comprehensive overview of risks, please refer to the "Risk Factors" contained in our most recent Annual Report on Form 20-F and other reports filed with or furnished to the U.S. Securities and Exchange Commission.

Source: QIAGEN N.V.

Category: PCR & Genomics

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