CAR T cell immunotherapy, chimeric antigen receptor T cell immunotherapy, proteins, cell therapy, gene therapy
Pharma & Biotech

Cell therapy

Cell therapy involves the transfer of functional cells that can be modified outside the body into patients. These cells can be from the patient (autologous) or a donor (allogeneic). This includes CAR-T cells, for which quality control is vital for their effectiveness. 

dPCR improves the precise quantification of modifications in these therapeutic cells, leading to accurate control over gene editing events. It also helps detect contaminating DNA, guaranteeing its safety and purity and ensuring reproducibility in lentivirus and CAR-T cell therapy production. It is also essential for detecting minimal residual disease (MRD) in cancer therapy, scanning therapy-related biomarkers and providing quality control during manufacturing.

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CAR T-cells

CAR-T cells (Chimeric antigen receptor) are rapidly emerging as a promising treatment for cancers and immune disorders. T cells are genetically modified to express CARs containing antibody-based recognition domains against cell-surface antigens on the target cell type. 
T cells, or other cell types, can be genetically manipulated using lentiviruses and retroviruses. Viral vectors have a high transduction efficiency, but they suffer from immunogenicity and cellular toxicity. 

CAR T cell immunotherapy, chimeric antigen receptor T cell immunotherapy
Pipetting artus cleanroom, manufacturing of an artus mastermix

CAR T-cell development

Viral vectors have not only been tested, but they are most commonly used. Current research efforts focus on using CRISPR editing for CAR-T cell engineering for reproducible, safe and potent CAR-T cell products. The current manufacturing process of these cells requires dedicated equipment and significant technical expertise, so there is an urgent need to develop a safe yet simple approach to CAR-T cell development.

In vivo, reprogramming of CAR-T cells using nanotechnology to encapsulate CAR-expressing plasmids provides an alternative approach. 

We offer a range of products for the quantification of viral titers, determination of viral vector integrity and detection of residual host cell DNA, as well as mycoplasma contamination.

Lentivirus production

Lentiviral vectors (LVVs) are powerful and versatile gene delivery tools widely used in cell and gene therapy due to their high packaging capacity and integration ability into the host genome, ensuring long-term expression. Effective and reproducible cell therapies require accurate characterization of viral vectors, including vector copy number (VCN) and titer determination, to meet regulatory requirements, maintain production consistency, and support therapeutic success while minimizing risks like insertional mutagenesis.

Cignal, lentivirus

Accurate quantification with the QIAcuity Digital PCR System

We offer a standardized workflow on the QIAcuity Digital PCR System, featuring the QIAcuity® Cell and Gene Therapy (CGT) dPCR Assays dedicated to lentiviral vectors. This system enables precise, reproducible and absolute quantification of viral titers and VCN without the need for a reference standard, offering improved reliability over traditional methods. 

Replication-competent Lentivirus (RCL) detection

During lentivirus production, monitoring for replication-competent lentivirus (RCL) is critical to ensure safety and compliance with regulatory guidelines. RCLs, which can arise from rare recombination events, pose risks such as insertional mutagenesis and unintended infections. Traditional cell culture-based detection methods can be slow and laborintensive, but our streamlined solution offers faster, more sensitive detection.

The QIAcuity RCL Quant Kit on the QIAcuity Digital PCR System provides robust, reliable RCL detection, accelerating quality control processes and reducing time-to-result in cell and gene therapy development.

With our advanced digital PCR solutions, you can ensure the highest quality standards for lentiviral vector characterization, supporting the development of safe, effective cell and gene therapies. 

Lentivirus infographic
Interested in a personalized package to meet your company’s needs?
We understand that one solution doesn't fit all. We offer a range of products, technologies and services for cell therapy research. Contact us and together we can develop a package tailored for you.
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Accelerate your data-driven cell therapies

From data analysis to databases, from gene expression to genome assembly, from interpretation to integration – QIAGEN Digital Insights has the breadth and quality of bioinformatics tools you need to drive meaningful insights and fuel cell therapy discoveries.