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Pharma & Biotech

Cell and gene therapy solutions

Cell and gene therapy with digital PCR
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from research to bioprocessing & QC

Cell and gene therapy's potential to either prevent disease progression or provide a cure offers a great clinical benefit over existing treatments, which are often developed to treat symptoms.

Gene therapy involves the transfer of genetic material, usually in a carrier or vector, and the uptake of the gene into the right cells of the body. This can include inserting a new copy of a gene, gene editing using technologies such as CRISPR and gene silencing. It is usually conducted by viral-mediated gene transfer with Adeno-Associated Viruses (AAVs), lentiviruses, or alternatively by non-viral gene delivery methods. Cell therapy involves the transfer of cells with the relevant function into the patient. The cells can be modified outside the body before being injected into the patient and can come from the patient (autologous cells) or a donor (allogeneic cells). An example of cell therapy is the widely known CAR-T cell therapy. 

The primary goal of cell and gene therapy is to treat or potentially cure illnesses by addressing their genetic causes. These therapies offer promising solutions for various conditions, including genetic disorders, cancers and chronic diseases, providing significant clinical benefits over traditional treatments.

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Benefits of working with us

  1. Advanced technology: We provide various ready-to-use kits and solutions. Among them is state-of-the-art digital PCR technology, which enhances the accuracy and reliability of genetic analyses, which is fundamental for both research and clinical applications.
  2. Comprehensive solutions: From research to bioprocessing and quality control, we offer integrated solutions that simplify therapy development and manufacturing processes.
  3. Expert support: With extensive experience and expertise in molecular tools, we provide valuable support and guidance throughout the therapy development lifecycle. 
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How to ensure the quality and reproducibility of your therapeutic product

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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 enable you to ensure the quality and reproducibility of your therapeutic product. Not only can you reliably and precisely determine plasmid quality, titer and integrity, but you can also perform robust contaminant testing, for example, to detect mycoplasma and residual host cell DNA.

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Quality control in cell and gene therapy

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.