European Society for Animal Cell Technology (ESACT) 2022
Lisbon, Portugal
June 26–29, 2022
Meet Genedata experts at ESACT 2022.
Don't miss the opportunity to see how Genedata solutions efficiently support the whole biopharmaceutical R&D workflow, including screening and protein engineering, expression and purification, characterization and analysis of protein therapeutics, cell line design and development, bioprocess optimization, stratification of clinical trial subjects, quality control of biologicals, and NGS-based cell line development and biosafety.
To get more information about Genedata solutions, please contact info(at)genedata.com.
Recommended Poster Presentations
Analyzing Perfusion Processes in an Integrated Process Development Platform
Eric Abellan, Business Account Manager, Genedata
We have built and extended a bioprocess development data management and workflow system to support automated workflows and increase throughput in cell line and process development. The data model of the platform has been designed to capture the heterogeneous data collected during process development campaigns. The platform has been extended to track analytical samples, harvested fractions, and time-series data of perfusion processes at any scale. We enabled the automatic addition of process and analytical data via online, at-line, and offline instruments, and manually via data submission forms. Submitted data are also automatically processed, aggregated, and visualized. We present concrete use cases showing how the platform supports clone evaluation and process development when perfusion processes are applied. We demonstrate the barcoded sampling and analytics workflow along this process and show how online and offline process and product quality data are processed and visualized. We show how the platform enables the correlation of process parameters with key performance indicators of the processes (e.g., specific productivity) and the product quality attributes (e.g., aggregation, glycosylation profiles). The impact of raw material batch-to-batch variation is also illustrated. In addition, the registration of harvested fractions and handover to the downstream processing is presented.
Increasing Efficiency and Quality in Protein, Cell, and Gene Therapeutics R&D Using an All-in-One Workflow Platform
Christoph Freiberg, Head of Product Development, Genedata
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.