Common use of Conclusions and Outlook Clause in Contracts

Conclusions and Outlook. In our study we developed a reliable method based on FIM coupled with CNN for detection, characterization and quantification of relevant particulate impurities, specifically Dynabeads. We showed that small amounts of Dynabeads can be detected in cell suspensions and a high precision in counting is achieved if the bead concentration is above the determined LOQ. Moreover, cells and cellular impurities, such as cell aggregates and adducts, can be easily classified by using CNN. Quantification of these particles can assist in monitoring manufacturing processes of CBMPs and assist in process and product characterization, such as stability testing. Further work is being carried out to enhance the capabilities of the method for other cell lines, the identification of multiple beads adhering to cells, as well as to characterize other populations of particulates potentially present in CBMPs, such as leachables, extractables and beads used as carriers for the ex vivo expansion of adherent cells. In addition, further evaluation of the presented method by using orthogonal methods could endorse the results obtained from the currently opaque processing algorithm, such as CNN36. This would increase confidence and understanding of FlowCam-CNN, presumably supporting in-process and quality control analyses at first, and potentially becoming a critical release test. Currently, we are not aware of other methods with similar performance and we believe that CBMP development can benefit from FlowCam-CNN in its current state. Particulates impurities in CBMPs traced by FIM-CNN