Platform methods validated at Eurofins BPT: the future for ATMP analytics

Luigi Barbarossa, Biologics Team Project Leader, Eurofins BioPharma Product Testing, LuigiBarbarossa@eurofins.com

Advanced Therapy Medicinal Products (ATMPs) define a broad category of complex and innovative biologics, which encompasses tissue, cell-based and gene therapy products.

These revolutionary medicines offer groundbreaking new opportunities, addressing unmet medical needs for rare and complex diseases. Among these, high costs and resource demands pose significant hurdles, especially in the transition from bench to bedside, when the demand for validated assays and GMP requirements must be fulfilled.

The Eurofins BioPharma Product Testing (BPT) network of laboratories is acutely aware of the challenges our customers face in this sector. To offer support, our experts, comprised of Biologists, Biotechnologists and Analytical Chemists, have been active for several years in testing ATMPs. Eurofins BPT offers a complete package of services to address their needs, including safety, characterisation, and identity for ATMPs.

In particular, Eurofins BPT Italy has recently expanded its staff with the aim of having a dedicated team for the development and validation of the platform’s methods. This approach is considered crucial due to the nature of cell and gene therapy products, which present several challenges, such as short product shelf life and limited batch size. Most recent implementations at our Italian site, for instance, include platform methods supporting Residual Plasmid DNA, Residual E1A DNA, Residual LTA DNA, Replication Competent Lentivirus (RCL) on drug products and Vector Copy Number (VCN).

Eurofins BPT is investing in platform methods to provide a broader package of services and is continually active in the validation of new ones, with a packed pipeline. The proposed platform approach aligns with Eurofins’ commitment to promoting the sustainability and affordability of Cell/Gene Therapies, supporting clients to meet regulatory requirements through all phases of assay development/validation, as well as routine testing when needed. For more information visit: https://www.eurofins.it/biopharma/ or contact us to learn more.