Genedata Bioprocess

Cell Line Development

High-yield, stably expressing cell lines are of critical importance for economically viable biopharmaceutical production processes. Development of clonal mammalian producer cell lines is a complex, lengthy, and costly process. Large numbers of cell pools and clones must be generated, screened, and tested to identify producer cell lines suitable for industrial, large-scale manufacturing processes, and this results in huge amounts of data that need to be captured, analyzed, and reported.

Genedata Bioprocess® supports the full cell line development (CLD) workflow and improves efficiency of the entire clone selection process – from initial transfection all the way to the final clone assessment and cell banking. The platform reduces timelines and costs to generate robust, clonal, and highly productive cell lines for manufacturing processes, and includes all necessary documentation.

Integrate

Integrates all cell line development workflows in one platform - from the drug candidate’s primary sequence, synthesis, cloning, and preparation of the corresponding expression construct(s) via the transfection, seeding, selection, screening, passaging, expansion, (sub-)cloning, and cryo-conservation of cell pools and clones - up to the in-depth evaluation of best-producer clones; systematically compiles all decision-critical information throughout the entire process on cell lines under investigation, such as data relevant for monoclonality assessment, bioreactor suitability, clone stability, and product quality assessment and clone history documentation

Capture

Captures date and time of all key steps in cell handling and cultivation, such as seeding, passaging, freezing and thawing; provides online and offline monitoring of growth in plates, flasks, and scale-down bioreactor models; tracks cell lines in micro-titer plates and other containers, such as deep-well plates, shake flasks, bioreactor vessels, and cryovials via full plate and cell material logistics tools

Process

Processes cell cultivation data, automatically calculates cell and growth parameters, such as cell age and growth rate, and traces back the final clone’s full lineage via parental clones and cell pools to the host cell lines (such as CHO and HEK)

Interpret

Systematically interprets and analyzes all relevant information, such as growth, productivity, and product quality data, throughout the entire process, by intuitive visualization and top-clone selection tool 

Report

Reports and documents all workflow steps and corresponding experimental results; automatically produces hand-over documents for upstream groups and regulatory authorities, such as Biologics License Applications (BLA)

Enable

Enables true high-throughput processes by automating the entire CLD process, employing HT, microtiter-based screening processes