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Cell therapy manufacturing and analytical testing points
From early discovery to patient delivery, cell therapies depend on analytical assays to help ensure product efficacy and faster vein-to-vein times. A variety of cell types including CAR-T, NK cells, induced pluripotent stem cells (iPSCs), and tumor-infiltrating leukocytes (TILs), have opened the door to potentially treating more patients and indications even beyond oncology. The fast pace of innovation has created a demand for new analytical solutions that deliver rapid, precise, and reliable insights, regardless of the workflow. At Thermo Fisher Scientific we have an extensive portfolio of off-the-shelf tests and automation-friendly workflows designed to help you meet your rigorous quality standards regardless of starting material.
Benefits of the Applied Biosystems SEQ solutions
- Analyze your product throughout the development process to help ensure product quality and safety
- Leverage a fully integrated solution, including assay kits, instruments, and analytical software to help save time, resources, and to allow for more consistent results to help therapies get to market quickly
- Utilize rapid molecular methods (real-time PCR, digital PCR, and DNA sequencing), enabling high sensitivity, fast results, and increased throughput—including the option to deploy an automated process for various tests
Product safety:
- Mycoplasma testing
- Adventitious virus testing
- Sterility testing
Product potency:
- Viral vector titer quantitation
Environmental monitoring:
- Microbial detection and identification
- Sterility testing
Cell therapy workflow testing points
While specific requirements can vary depending on the regulatory jurisdiction and the nature of the cell therapy*, common tests include:
- Product safety: Includes assessments for sterility and viral contamination
- Viral vector characterization: Testing for both total/physical and infectious titer used in cell engineering
- Environmental monitoring: Microbial contamination detection and identification within the manufacturing environment
Upstream and downstream phases in a cell therapy development workflow
*Regulatory agencies may require additional data or specific assays tailored to the unique attributes of therapeutic antibodies to ensure their safety, efficacy, and quality.
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