Cell and Gene Therapies – When Speed Matters
Tessa Patton, Manager, Bio/Pharmaceutical Microbiology; Chris Smith, Manager, Mycoplasma Services; Denise Kurtz, Group Leader, Bio/Pharmaceutical Microbiology
With the advent of Cell and Gene Therapies, specifically Autologous Cell Therapies (ACT), Eurofins has recognized that our clients with short shelf life products are in need of a solution to decrease the length of time it takes to obtain critical results to release life-saving therapies to patients. Eurofins BioPharma Product Testing (EBPT) offers a suite of services that allows us to be a one-stop-shop for your rapid and facility testing needs.
Rapid mycoplasma testing has been accepted in our industry as an alternative to the 28-day compendial-derived testing that has been available traditionally. Eurofins BPT offers two rapid mycoplasma detection methods to our services. MycoSEQ™ is a real-time qPCR assay using magnetic bead extraction and Power SYBR® Green dye. This method allows for standard results in five days, with the ability to support three-day prioritized results with preapproval. BioFire® is a single cartridge assay, performing both extraction and PCR within the cartridge that detects RNA from mycoplasma. This method allows for standard results in three days with the ability to produce prioritized results in less than 24 hours with preapproval. Comparability studies to show full equivalence for a product with either system are able to be performed as our lab also performs the traditional compendial methods and has live Mycoplasma onsite.
Eurofins BPT has also validated a method for a rapid contamination check. The method employs the use of the Biomerieux BACT/ALERT® 3D system. The method was validated in accordance with USP <1223> and was determined to be non-inferior to the USP <71> Sterility test. The method is able to provide a final result of positive or negative after seven days of incubation. In addition to the final result after seven days of incubation, the service offering provides a three-day interim read that is reported on a Quality Assurance approved Certificate of Analysis.
In order to provide a meaningful set of results for evaluation prior to dosing, Eurofins BPT has streamlined the process to execute the traditional Kinetic Chromogenic method for Bacterial Endotoxin Testing in order to provide a final result in three days.
In addition to rapid testing, ensuring that the facility meets the regulatory requirements for the manufacturing of safe and effective products, it is important to perform Environmental Monitoring Performance Qualifications and have a routine environmental monitoring plan in place. Eurofins BPT offers consultation to assist with designing a sampling plan and can also provide qualified analysts to perform the collections of non-viable air particulates, viable air, and surface samples utilizing state-of-the-art equipment. Eurofins BPT also provides analysts for on-site collection of purified water and compressed air/gases. All samples are transported back to Eurofins BPT and tested within 24 hours of collection with a turnaround time (TAT) of 14 days. Clients may also ship their samples directly to Eurofins BPT where we can provide the testing specific to the client’s parameters with the same TAT of 14 days.
With this suite of services, our clients are guaranteed the shortest turnaround times available with the highest quality results for the tests needed to ensure their Cell and Gene Therapies are safe to be administered to patients.