Presented at Bioprocess International Europe, Amsterdam, Netherlands
We have implemented a dedicated end-to-end platform to support the whole bioprocess development workflow. Co-developed in close collaboration with leading biopharmaceutical companies, the platform fully automates the cell line and scale-down upstream process assessment. In addition, the system manages upscaling, downstream process, analytical and formulation development, which enables the lineage tracking of all batches, starting from the transfection of a cell line all the way to the vials containing the final drug product. Analytical data, as well as drug candidate and expression construct information, are related to these batches, enabling systematic assessment in one platform of processes and molecules at any stage in process development. The platform can be applied to antibodies (IgGs, novel bi- and multi-specific formats) and other therapeutic proteins (e.g., engineered FVIII variants, fusion proteins). It directly integrates with all instruments, such as pipetting robots, bioreactors, control systems, and bioanalyzers. The system provides the foundation for an increase in throughput in bioprocess development campaigns as well as improved quality in molecule developability assessments. A query and reporting infrastructure also enables comprehensive learning across different campaigns.