Rapid Sterility Testing to Complement Compendial Testing

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Protect your cell therapy with fast, actionable results

In the field of cell therapy production, sterility testing is a critical step to ensure the quality and safety of the final product. As the industry moves towards faster production processes and deals with the limited shelf life of cell therapy products, prompt detection and prevention of contamination are essential. Rapid sterility testing enables the timely identification and resolution of potential contamination sources, helping to reduce the risk of product loss and unexpected production delays. This proactive approach not only enhances workflow efficiency but also maintains the integrity and effectiveness of cell therapy products.

Challenges with compendial testing

While compendial testing is standardized and widely accepted, it presents several challenges for cell therapy products. Traditional compendial sterility tests can take 14 to 28 days to yield results, and even updated growth-based technologies can take up to 7 days. This extended timeframe is problematic for cell therapies, which often have short shelf lives and need to be administered promptly. Finding contamination days into testing can jeopardize release timelines, leading to costly deviations and potentially devastating batch failures.

Delays can also negatively impact patient outcomes.
Incorporating rapid sterility testing into your workflow allows you to obtain critical answers while awaiting confirmation from growth-based methods. This means you don't have to wait 14 days to know if contamination is present.

Rapid sterility testing to complement compendial testing

Help ensure your products meet the highest standards of sterility with Thermo Fisher Scientific's compendial testing solutions. Our reliable and efficient services offer the assurance you need for regulatory compliance and product integrity.
 

The Applied Biosystems SteriSEQ Rapid Sterility Testing Kit

The SteriSEQ Rapid Sterility Testing Kit complements compendial testing in several key ways:

  • Accelerated results: The SteriSEQ kit offers faster time-to-results compared to traditional compendial and other growth-based methods. Early indications of contamination enable quicker decision-making and potentially reduce production delays.
  • In-process monitoring: Using the SteriSEQ kit as an in-process control allows manufacturers to detect contamination early in the production cycle. Early detection, indicated by a rise in contaminant DNA levels, facilitates timely corrective actions before the final product undergoes compendial sterility testing.
  • Enhanced quality assurance: The SteriSEQ kit serves as an additional layer of quality assurance, complementing compendial tests with microbial coverage based on in silico testing for over 16,000 bacterial species and 2,600 fungi species. This dual approach enhances the reliability and robustness of sterility testing protocols.
  • Minimized risk of product loss: Rapid sterility results help identify contamination issues sooner, minimizing the risk of large-scale product loss and reducing economic impacts.
  • Improved efficiency: Rapid results help streamline various aspects of the production cycle, including storage and distribution, especially for products with short shelf lives. This facilitates better inventory management and reduced waste.
  • Regulatory compliance: The SteriSEQ kit can be used alongside compendial testing to support compliance with regulatory standards. This dual approach helps satisfy both the need for speed and adherence to established guidelines.
  • Better resource allocation: Early identification of potential sterility issues allows for more efficient resource allocation, timely resolution of contamination problems, and overall optimization of production processes.
  • Enhanced investigations and corrective actions: Fast contamination detection enables more timely and effective investigations and corrective actions, facilitating quicker recovery and less disruption to production workflows.

The SteriSEQ kit can enhance and complement compendial sterility testing strategies by offering rapid, reliable results. This advancement helps improve overall efficiency, quality assurance, and risk management in the production of cell therapy and other biopharmaceutical products.

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