Search Thermo Fisher Scientific
- Contact Us
- Quick Order
-
Don't have an account ? Create Account
On this page:
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.
Request a technical consultation
No matter your questions, we are here to help. Our experienced team of scientists and technical specialists is ready to assist you in choosing the right solution and products. Complete this form to start the conversation.
Related resources
Analytics Knowledge Hub
Explore the Analytics Knowledge Hub from Thermo Fisher Scientific, providing a robust collection of webinars, articles, eBooks, infographics, and other digital resources to help you optimize the use of our products in your bioprocess workflow.
Additional resources
Enhance your bioprocessing knowledge with educational content to help you understand issues, solve problems, and make solid decisions.
Deep dive into a targeted collection of scientific application notes, case studies, posters, white papers and more for bioprocessing.
Learn, evaluate, connect.
Connect with a Bioprocessing representative or request more info.
Thermo Fisher Bioprocessing Portfolio
For Research Use or Further Manufacturing. Not for diagnostic use or direct administration into humans or animals.