Cell-based medicinal products: grant rejected, paper published
Cell-based medicinal products (CBMPs) belong to an innovative and heterogeneous group of medicines called advanced therapy medicinal products (ATMPs). The limited analytical toolbox for CBMP characterization and release testing is one of the reasons why CBMP development is so challenging.
In 2016 the United States Pharmacopeia posted a call for a global 1-year fellowship on “particle characterization technologies that could lead to general chapter additions/improvements and/or methods for monograph use”. Adam Grabarek (PhD student) submitted an innovative project proposal entitled “Analytical characterization of particulate matter in CBMPs”. Unfortunately Adam did not obtain the grant, but we liked his idea so much that we decided to perform the work anyway, in close collaboration with colleagues from LUMC and Coriolis Pharma. This eventually led to a joint publication on the characterization of particulate impurities in CBMPs, where Adam combined flow imaging microscopy with deep learning for image analysis. Adam’s paper is the result of a multidisciplinary effort, including expertise in ATMP development, particle characterization and artificial intelligence. The paper was published online on June 2, 2020 in Cytotherapy, the flagship of the International Society for Cell & Gene Therapy: https://www.sciencedirect.com/science/article/pii/S1465324920306332