STUDIUS: Commentary

Data, errors and headaches: How STUDIUS™ and the Solentim Ecosystem is tackling the crisis in data consolidation and reporting in Cell Line Development.

Operating within the structure of Chemical, Manufacturing and Control (CMC), Cell Line Development (CLD) is a pivotal control strategy within the development of therapeutic antibodies. Risk-based strategies towards quality control are deeply embedded in CLD yet challenged, as are CLD scientists, on a daily basis with the burden and worry of data consolidation.

Methodologies, utilised in CLD, include viable cell counting, confluency, single cell seeding, plate transfer and consolidation, titer assays and microscopy. It is central to this narrative that data from all these aspects are joined together in a single story of a cell’s journey through this process.

In this document, Solentim describes how STUDIUS, a bespoke data management system, has changed Cell Line Development. An integrated view on project data all the way from seeding to selection. An entire project in a single report. A protected ecosystem of data for users and managers alike.

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