GMP BioPharma Product Testing laboratory network provides both US & EU product release support to global organizations
Jon S. Kauffman, Ph.D., Senior Director, BioPharmaceutical Sciences
Biopharmaceutical sponsors typically market products in multiple regions under different regulatory authorities, and therefore must identify, qualify and contract with both US and European laboratories. Eurofins Biopharma Product Testing Laboratories’ expertise in bringing products to the market under both the US and EU regulatory environments allows our global clients to work with just one organization, utilizing our harmonized quality and IT/LIMS systems.
For example our Lancaster, US, site validated a variety of methods to support a client’s NDA submission and their release testing in the US. This client then needed to find a European laboratory to support them with their Marketing Authorization Application (MAA) filing in the EU within a short timeframe. Our Milan, Italy, laboratory quickly evaluated the methods and determined that they were capable of running them. The analytical method transfer (AMT) protocol development was a collaborative effort among our client, the Lancaster lab, and the Milan lab. A method verification approach was taken and described in the protocol, including the analytical testing to be performed and the acceptance criteria to be met for system suitability, specificity, accuracy and precision. All methods were transferred successfully, and the Milan lab was qualified to perform testing to meet the client’s timelines and EU requirements.
In another example, we had been supporting a critical release testing program in the US for a product in short supply, when the client approached us with the request to support the EU release testing also. A risk-based analysis of the methods was performed. The more critical, higher-risk methods were transferred through parallel testing, in which samples were run at both sites with the Lancaster, US, site as the reference laboratory and its Ireland site as the receiving laboratory. Subject matter experts (SMEs) from Lancaster traveled to the Ireland site to perform hands-on training of the technique-sensitive methods. The transfer protocol described the number of replicates (typically n = 6), as well as, the acceptance criteria for percent relative standard deviation (%RSD) and absolute differences between labs. Again, all methods were successfully transferred and our client can release product in both the US and EU. Finally, we are taking another approach for method implementation for some of our large biologics programs. One of our clients required labs qualified in both the US and EU to support their monoclonal antibody stability and release programs. Therefore, the method implementation at two sites was accomplished through method covalidation. The protocol described the testing of critical validation parameters such as intermediate precision and accuracy to be performed at both sites (and at our Munich, Germany, facility in the case of cell-based assays). This allowed for simultaneous method implementation.
Critical success factors of these method installation projects include strong project management, effective communication, extensive coordination among the US and EU laboratories and the client, collaborative protocol development, and SME driven training. This all results in shorter timelines and reduced costs to our global clients.