Report on prototype’s operation monitoring & compliance with QS/GMP/CQA regulations

Following the installation of the continuous nano-template-assisted membrane crystallizer at the CPI’s National Biologics Manufacturing Centre (UK), the crystallizer will be evaluated using the optimal conditions determined in the earlier work packages. This will include both the mAb and the HEL4 fragment, unless one of the molecules has already been ruled out by earlier results. The conditions selected will include biopharmaceutical product purity level, the product concentration, pH/buffer conditions, addition of precipitants or nanotemplates and transmembrane fluxes/input flow rates. During an experimental program, CPI will test the robustness of the new process and the ability to create product of a consistent quality and purity. A report will be prepared that describes how suitable the technology, in its current form, is for GMP operation as part of a biopharmaceutical manufacturing process. Recommendations will be made for further development that would be required for implementation of the technology in an industrial environment and compliance with relevant quality standards and regulations.