Genedata Bioprocess® streamlines the generation and assessment of mammalian cell lines, making the development of GMP-compliant production cell lines more cost-efficient. The system improves efficiency by facilitating the entire clone selection process – from initial transfection all the way to clone assessment and cell banking of the final production cell line. It registers all clones and samples under a unique ID, enabling the systematic integration and interpretation of all clone information, such as productivity and quality data, throughout the entire process.
Genedata Bioprocess tracks all cell lines – primary host cell lines (CHO, HEK) as well as developed cell lines – and documents clone parent-child relationships. All workflow steps, such as dilution, re-plating, and subcloning, are documented. The system records seeding and incubation conditions, transfection and selection pressure protocols, and provides online monitoring of growth characteristics, confluence images, passaging, cryo-conservation, thawing and freezing cycles, monoclonality (including d0 images), as well as genetic stability and other clone selection data. Fully compatible with high-throughput clone screening instruments, Genedata Bioprocess provides full plate logistics tools to manage and track cell lines in micro-titer plates and other containers, such as deep-well plates, bioreactors, cultiflasks, and cryovials. Dedicated interfaces directly integrate with liquid handling systems to fully automate the sample management process.
The system auto-generates a variety of cell line development reports, which can be used for regulatory documents, such as for BLA submissions.