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

Cell and gene therapy

The potential of cell and gene therapies to either prevent disease progression or provide a cure offers a great clinical benefit over existing therapies which are often geared toward the treatment of symptoms.

Gene therapy involves the transfer of genetic material, usually in a carrier or vector, and the uptake of the gene into the appropriate cells of the body. This can include the insertion of a new copy of a gene, gene editing using e.g., CRISPR technology, and gene silencing. Gene therapy is usually performed by viral-mediated gene transfer with Adeno-Associated Virus (AAV) or lentivirus or alternatively by using plasmids. Cell therapy involves the transfer of cells with the relevant function into the patient. The cells are modified outside the body before being injected into the patient, and can come from the patient (autologous cells) or a donor (allogeneic cells). Examples of cell therapy include CAR T-cells.

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Cell and gene therapies are inherently complex, with a large degree of variability. The superior accuracy and precision offered by digital PCR enables you to ensure the quality and reproducibility of your therapeutic product. Not only can you reliably and precisely determine plasmid quality, viral titer and vector copy number, but you can also perform robust contaminant testing, for example, to detect mycoplasma and residual host cell DNA.

Cell and gene therapy events
Explore upcoming and past events to find out what's happening globally in the cell and gene therapy field

We understand how important it is to establish quality control testing for cell and gene therapy products. With recent advances in digital PCR it is increasingly becoming the technology of choice to implement in robust manufacturing and quality control processes.

We took digital PCR one step further with the QIAcuity Digital PCR System, a fully-integrated system based on nanoplate technology which promises a faster time to result, higher throughput, multiplexing and scalability.

A comprehensive assay portfolio integrates seamlessly with the QIAcuity instruments, nanoplates and kits to offer the flexibility and accuracy required for your cell and gene therapy applications.

PCR requirements in a GPM settings

The system is coupled to a feature-rich QIAcuity Security Edition Software enabling labs to adhere to 21 CFR Part 11 compliance requirements in a GMP setting.

We also guarantee Installation Qualification (IQ) and annual Operational Qualification (OQ) services, 24/7 technical and scientific support and repairs performed by certified professionals ensuring you reliable quality control.