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Cell therapy manufacturing and analytical testing points

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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On-demand webinar

A journey to cell therapy manufacturing: From R&D to lot‑release                               

Application note

Rapid sterility testing to help ensure the safety and quality of cell therapy products 

eBook

Analytical method and testing strategies for biologics production                                


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

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Thermo Fisher Bioprocessing Portfolio

Upstream bioprocessing

Develop and scale biomanufacturing processes efficiently with trusted technologies and full-service support.

 

Downstream bioprocessing

Streamline downstream biomanufacturing and improve product quality with innovative technologies and outsourcing services to drive efficiency.

Assurance of supply

We strive to support industry growth by investing in capacity and quality systems for a reliable supply of critical materials.