Autologous Cell Therapies are an advancement in personalized medicine using a person’s own cells to effectively treat a disease. Due to the immediate nature required for returning the cells to patients, rapid biosafety testing approaches must be utilized to demonstrate the cells have not been contaminated during cellular processing.
Eurofins BioPharma Product Testing provides GMP-validated biosafety assays to test for the presence of microbial, mycoplasma, and endotoxin contaminations in less than half the time of the traditional methods.
Eurofins’ GMP rapid test methods meet and exceed the quality standards our clients and regulatory reviewers expect from a GMP service provider, while providing a 3-day Certificate of Analysis and 24-hour access to data.
Rapid Sterility Testing
Using the BacT/Alert® system, our rapid sterility approach is qualified against the organisms listed in USP <71>. In order to start the testing as soon as possible, Eurofins provides quality control released BacT bottles for our clients to inoculate on-site during cell processing. The BacT test method has a lab duration of 10 days with the majority of the organisms detected by day 3-7. To enable patients to receive their cells, a 3-day interim read is shared by a Certificate of Analysis to our clients to help make an informed decision in patient dosing.
Rapid Mycoplasma Testing
The mycoplasma PCR test method, utilizing the MycoSEQ platform, has a 3-day turnaround for the final Certificate of Analysis. The method is qualitative and is validated to have a limit of detection of ≤10CFU/mL or ≤10IU/mL. The MycoSEQ method’s limit of detection was verified by performing the method on mock samples, inoculated with a live organism at or below the claimed limit of detection by the vendor. The mycoplasma PCR method meets or exceeds the USP <63>, EP 2.6.7, and JP Chapters limit of detection requirements.
Endotoxin Testing
Chromogenic endotoxin testing, using LAL, is also necessary to demonstrate that the cell processing technique did not introduce an endotoxin contamination. The final report for this test method can be provided in 3 days to offer endotoxin safety data. The test method has been verified and validated using USP <85>, EP 2.6.14, and JP 4.01.
The three test methods described here are the common rapid tests performed to assess the cellular product and gather information on potential contaminants prior to patient administration. Eurofins BioPharma Product Testing focuses on client timelines to execute the GMP testing rapidly. Our focus on quality is a driver behind providing accurate biosafety information, enabling patients to receive their cells without the concern of a potential contaminant.
Open lines of communications are critical to execute rapid testing in the GMP environment. Eurofins has a dedicated project management team focused on the GMP biosafety testing, including the Autologous Cell Therapy rapid test requirements.
The development of Autologous Cell Therapies is vastly different than traditional biopharmaceutical products, or even other cell and gene therapy products, and the complexities of this novel therapeutic treatment span the development pipeline. Watch Eurofins’ on-demand webinar, Decrease Needle to Needle Time for Autologous Cell Therapies with Rapid Biosafety Testing, to learn more about these rapid testing solutions, including instrumentation required, validation of the test methods, method suitability B&F requirements, timelines for results, and more.
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