ESACT 2022, Lisbon
June 26, 2022
We designed a combined workflow platform (Genedata Biologics®/ Genedata Bioprocess® ). This highly structured database has been extended to manage not only protein-based therapeutics but also the innovative cell and gene therapeutics described above. The system has been adjusted to reflect the complex procedures associated with the design, screening, and production of these modalities across dedicated workflow steps. Novel tools have been implemented to track the uniqueness of cell and gene therapeutics and to perform co-transfections and viral transductions, complexation, and formulations (e.g., in lipid nanoparticles), on top of upstream cultivation and downstream purification unit operations. In addition, new barcoded sample-based analytical workflows have been introduced to track product quality at each step of the R&D process. We present concrete use cases for screening and production of various protein, cell, and gene therapeutic modalities. A special focus is on screening and production of a) multi-specific antibodies, b) AAVs, c) RNAs and d) CAR-T cells. The traceability from the final product to individual sources such as plasmids or libraries is discussed as well as the unmatched flexibility in handling and exploring these novel modalities. In addition, the platform serves both individual lab scientists as well as the whole R&D organization.