Rapid Sterility Testing

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Confidently accelerate cell therapy manufacturing with simple, rapid sterility testing

In cell therapy production, rapid sterility testing plays a critical role in helping to ensure the quality and safety of the final product. Given the fast-paced nature of this production process and the limited shelf life of cell therapy products, it is imperative to detect and prevent any further contamination as early as possible in the workflow, such as testing raw materials or in-processing samples. By implementing rapid sterility testing, potential sources of contamination can be uncovered and addressed promptly, helping to reduce the risk of product loss and unexpected production delays and outcomes. This not only enhances the overall efficiency of the workflow, but also helps to maintain the integrity and efficacy of the cell therapy product.

SteriSEQ Rapid Sterility Testing System

The Applied Biosystems SteriSEQ Rapid Sterility testing system is an integrated, real-time PCR (qPCR) solution for rapid sterility testing of cell therapy products. The SteriSEQ Rapid Sterility Testing workflow provides a simple, easy-to-implement approach to contaminant detection, with a functionally confirmed, commercially available qPCR assay kit and industry-leading, real-time PCR instruments with dedicated analytical software to help enable regulatory compliance.

 

Key system features:

  • Actionable qPCR results in less than 5 hours
  • Single-well, multiplexed assay detects both bacterial and fungal contamination
  • Efficient qPCR workflow solution, including SAE compatible software
  • Global network of regulatory and field application specialists for support from method development and implementation through validation

Simple, fast qPCR workflow

SteriSEQ Rapid Sterility Testing Assays

Central to the SteriSEQ Rapid Sterility Testing System is its robust, multiplexing qPCR assay. Leveraging the high performance of trusted TaqMan chemistry, the SteriSEQ Assay can detect more than 16,000 bacterial species plus 2,600 species of fungi* and can detect contamination in raw materials and in-processing samples in cell densities up to 1e6 cells.

 

Key assay features:

  • Fast—Delivers actionable results in less than 5 hours, enabling rapid contamination detection of in-process and raw materials, helping expedite the release of your cell therapy product
  • Sensitive—Detects bacterial and fungal species at 5-25 genome copies per reaction
  • Specific—Designed specifically for bacteria (16S rRNA) and fungi (18S rRNA), with no known cross-reactivity to in-process byproducts or sample matrix effects
  • Efficient—Minimizes use of sample material by simultaneously testing for bacteria and fungi, preserving precious cells for final product
  • Accurate—Discriminatory positive control helps eliminate false positives and an internal positive control helps ensure PCR reaction consistency in the samples

 *Based on in-silico testing

View SteriSEQ system brochure

Learn more about the use of rapid, qPCR-based sterility testing for cell therapy production

This application note details specificity experiments for the six species listed in the USP <71> guidelines for sterility testing, as well as category 2 bacterial and fungal species. It illustrates how the SteriSEQ Rapid Sterility Testing Kit can be used for in-process testing to help ensure confidence in the cell therapy bioprocessing workflow. 

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No matter what your questions are, we are here to help. Our experienced team of scientists and technical specialists are ready to assist you in learning more about implementing rapid sterility testing into your cell therapy workflow. Complete this form to start the conversation. 

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