Eurofins BioPharma Product Testing provides harmonised US and EU support to global organisations

By Jon S. Kauffman, Ph.D., Eurofins Lancaster Laboratories,  JonKauffman@eurofinsUS.com

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. As the largest global network of harmonised BioPharma GMP product testing labs, Eurofins BioPharma Product Testing's (EBPT) expertise in bringing products to the market under both the US and EU regulatory environments allows global clients to work with just one organisation, utilising harmonised quality and IT/ LIMS systems.

For example, Eurofins Lancaster Laboratories (ELLI) had been supporting a critical release testing programme in the US for a product in short supply, when the client requested support for their EU release testing. A riskbased analysis of the methods was performed. The more critical, higher-risk methods were transferred through parallel testing, in which samples were run at the Lancaster, US, site as the reference laboratory, and its Ireland site as the receiving laboratory. Subject matter experts (SMEs) from Lancaster travelled to Ireland to perform hands-on training of the techniquesensitive methods. All methods were successfully transferred, and the client can release product in both markets.

EBPT is taking another approach for method implementation for some of its large biologics programmes. One client required labs to be qualified in both the US and EU to support their monoclonal antibody stability and release programmes. Therefore, method implementation at EBPT US and Munich labs was accomplished through method co-validation. The protocol described testing of critical validation parameters such as intermediate precision and accuracy to be performed at both sites, allowing for simultaneous method implementation.

Also notable, after ELLI validated a variety of methods to support a client's NDA submission and release testing in the US, Eurofins' Milan lab was then able to support this client with their successful Marketing Authorisation Application (MAA) filing in the EU through seamless analytical method transfer (AMT) protocol development and collaboration.

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. All this results in shorter timelines and reduced costs to global clients.

For more information, visit www.pharma.eurofins.com.