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Evaluating the sterility of your therapeutics for product quality and safety
The complexity of cell therapy workflows can significantly increase the risk of contamination, making sterility a critical concern. Contaminants—such as bacteria, fungi, and viruses—pose a patient safety risk and rigorous safety testing ensures compliance with stringent regulatory standards. Discover our fast and highly-sensitive methods for mycoplasma detection and rapid sterility testing.
Mycoplasma detection
Sensitive, specific, and accurate mycoplasma testing is essential for safeguarding both the manufacturing process and the final product
Testing for mycoplasma in cell therapy manufacturing is required to ensure the safety of these products. Regulatory agencies require sensitive and specific mycoplasma testing methods to ensure compliance with safety and quality standards. The presence of mycoplasma can significantly compromise the quality, safety, and efficacy of the final product, as well as pose serious health risks to patients.
Moreover, contamination during the production process could result in reduced yields and lower quality or functionality leading to batch failure. Through thorough mycoplasma testing, manufacturers can help prevent costly production delays, maintain product integrity, and ensure the delivery of safe, effective therapeutics to patients.
Rapid sterility testing
Monitor your cell therapy workflow by implementing rapid sterility testing
Raw materials and in-process rapid sterility testing in cell therapy manufacturing addresses the need for early and accurate detection of potential microbial contamination. This helps ensure the safety and efficacy of the final product while allowing for efficiency during the manufacturing process.
Traditional methods can take up to 14 days to deliver results. qPCR-based testing functions as a rapid risk assessment tool for detecting bacterial and fungal DNA during the production process, often delivering results in less than 5 hours. This advanced technique enables the detection of potential contaminants with greater sensitivity and speed, thereby helping to improve the overall quality assurance within cell therapy production processes.
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