Autologous Cell Therapy
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 GMP rapid test methods meet and exceed the quality standards our clients and regulatory reviewers expect from a GMP service provider.
Eurofins BioPharma Product Testing network of laboratories offers 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.
Why Choose Eurofins BioPharma Product Testing?
- We provide a 3-day interim Certificate of Analysis (CoA) for our GMP rapid sterility method. We provide the final CoA for both mycoplasma PCR and endotoxin within 3 days.
- Our large and flexible Microbiology team of 80 microbiologists provides expansive capacity and over 40 years of experience serving the bio/pharmaceutical industry.
- Our industry leading online data portal, LabAccess, provides customers access to our LIMS system, allowing 24-hour access to data.
- Our dedicated Project Management team focuses on biosafety, rapid testing, and client communications to assure on time delivery in our GMP environment.
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 BioPharma Product Testing network of laboratories 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, Eurofins BioPharma Product Testing has built in a 3-day interim read that is shared by a Certificate of Analysis to our clients to help make an informed decision in patient dosing.
Rapid Mycoplasma Testing
The Eurofins BioPharma Product Testing 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. Eurofins BioPharma Product Testing verified the MycoSEQ method’s limit of detection 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>, Ph. Eur. 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>, Ph. Eur. 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 network of laboratories 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 communication are critical to execute rapid testing in the GMP environment. We have a dedicated project management team focused on the GMP biosafety testing, including the Autologous Cell Therapy rapid test requirements. Our highly trained project management team is a crucial component in communication plans between clients and Eurofins BioPharma Product Testing.
The table listed below provides general information on the Autologous Cell Therapy test methods performed at Eurofins BioPharm Product Testing. Please reach out to your business development representative or project manager today to learn more about our rapid GMP Biosafety Testing services.
