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Protect your product at every stage
In-process sterility testing is a critical component of manufacturing quality control for cell therapy products. It helps ensure production control and helps minimize microbial contamination risks before the final product release. By detecting contamination early, such as during cell expansion, you can help prevent compromised batches, save time, and reduce waste associated with materials, labor, and costs. Additionally, user-friendly software can streamline and help enhance the testing process, making it more efficient.
The Applied Biosystems SteriSEQ Rapid Sterility Testing Kit offers actionable results in as little as 5 hours, helping to keep your product safe and maintain high standards of quality.
Precision in practice – guidance for analytical excellence
In this quick 60-second video (give or take), our field application scientist tackles your top FAQ about how SteriSEQ enables early fungal and bacterial detection at critical contamination points. See how this rapid sterility testing method complements traditional approaches, aligns with regulatory guidance, and helps ensure timely delivery of life-saving therapeutics. Get the answers you need, fast!
Innovative advancements in sterility testing
Real-time PCR (qPCR) technology: Traditional growth-based methods are often too slow for in-process testing. The SteriSEQ kit leverages real-time PCR (qPCR) technology, enabling rapid and reliable sterility testing throughout the production process.
Confidence in culture integrity: By using SteriSEQ testing kits at both the beginning and end of the cell expansion process, you can achieve comparable results at both points. This consistency supports high confidence that the culture is uncontaminated and will pass the final sterility test.
Preventing process contamination
Contamination in the initial intake material, such as apheresis, can compromise the entire downstream process, including cell expansion, harvesting, and final formulation. Early detection of contamination allows for corrective measures to be taken before further resources are invested. This proactive approach is designed to detect and address potential contamination issues promptly, helping to reduce the risk of widespread contamination and production delays.
Key benefits of in-process testing with SteriSEQ assays
- Early detection: Rapid identification of contamination early in the production cycle allows for timely corrective actions, helping flag compromised batches and supporting product safety
- Cost savings: Early contamination detection helps minimize waste of materials and labor and can lead to cost savings
- Improved quality assurance: The SteriSEQ kit offers an additional layer of quality assurance, complementing traditional compendial tests and supporting the overall reliability of sterility testing protocols
- Resource optimization: Early identification of sterility issues allows for better resource allocation, addressing contamination problems more effectively and improving overall production processes
- Streamlined workflow: User-friendly software enhances the testing process, making it more efficient and less prone to human error
The SteriSEQ Rapid Sterility Testing Kit is an invaluable tool for in-process sterility testing in cell therapy production. Its rapid, reliable results help maintain high quality and safety standards while improving overall efficiency and reducing costs. By incorporating SteriSEQ into your workflow, you can help protect your product at every stage, supporting the integrity and effectiveness of your cell therapy products.
Cell therapy workflow
Enable rapid detection and response to a potential contamination event with this workflow, from cell isolation to infusion.
Cell therapy workflow steps
Post-apheresis/cell intake
- Cryopreserved samples: Sterility testing post-thaw is crucial for cell therapy products, as the freezing and thawing process can introduce risks or conceal existing contaminants
Initiation/activation
- Cell sources: Human or animal cells used in therapy should be tested for potential contaminants (bacteria, fungi, and viruses); donor screening and pathogen testing are essential to avoid contamination
- Media and reagents: The growth media, supplements, and reagents used in cell culture should be tested for sterility before use to prevent introducing contaminants
Cell expansion/growth
- Culture media and reagents:
- Nonsterile media: If the media, supplements, or buffers are not properly tested to be sterile before use, contaminants such as bacteria, fungi, or mycoplasmas could be introduced; repeated use of media or errors during media preparation and transfer can also increase the risk
- Serum and supplements: Serum or growth factors added to culture media are potential sources of contamination if not properly filtered or tested beforehand
- Human error and aseptic technique lapses
- Manual handling: During the addition of media or supplements, or the transfer of cells between containers, contamination can occur from the operator’s hands, gloves, or improper handling of equipment
- Aseptic technique breakdowns: Failure to adhere strictly to aseptic techniques, for example, improper gowning, unsterilized equipment, or unintentional exposure of sterile materials to the environment
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