Genedata Biologics、Bayer Pharma社と細胞株育種データ管理プラットフォームを共同開発へ
Novel Cell Line Development (CLD) data platform to support the generation and assessment of mammalian production cell lines
March 17, 2015
Genedata, a leading provider of advanced software solutions for drug discovery and life science research, today announced a collaboration with Bayer Pharma AG to develop a new workflow management system to support the automation of the Cell Line Development (CLD) process for mammalian cells used to produce biopharmaceuticals. Genedata’s new CLD Data Platform is an enterprise software system that boosts the efficiency of cell line and process development and increases process quality. It tracks all clones produced and screened in high-throughput mode, collects all relevant characterization data, such as productivity and quality parameters, and streamlines high-throughput workflows by interfacing with automation equipment such as pipetting robots, measurement devices, and bioreactors. The CLD Data Platform enables a seamless and smooth generation of GMP-ready cell lines and their transfer into process development.
Integrated Platform for Cell Line Development: Significant Efficiency and Quality Gains
Genedata’s CLD Data Platform is an innovative software system, which will streamline the development of stably expressing cell lines for biopharmaceutical production. The data platform can be applied to both antibodies (IgGs, novel formats) as well as other therapeutic proteins. By streamlining the generation and assessment of mammalian cell lines, the platform supports the cost-efficient development of cell lines suitable for GMP production. The new CLD Data Platform seamlessly integrates with Genedata Biologics, Genedata’s established first-in-class product for biopharma discovery organizations. Genedata owns the commercialization rights to the CLD Data Platform and will offer this new technology to other biopharma development organizations later this year.
“We are pleased to collaborate with Bayer Pharma AG on this strategically important project to optimize cell line and bioprocess development,” said Dr. Othmar Pfannes, CEO of Genedata. “The new CLD Data Platform addresses a critical bottleneck in the development of innovative protein therapeutics, and will help to shorten timelines to bring about cost savings. By extending our product portfolio to downstream processes, with an initial focus on cell line and bioprocess development, we are another step closer to providing a fully integrated platform for biopharma research, development, and manufacturing.”
About the CLD Data Platform
The CLD Data Platform tracks all cell lines - primary host (CHO, HEK) as well as developed cell lines - and documents clone parent-child relationships including all dilution, re-plating, and subcloning steps. It records relevant seeding and incubation conditions, and transfection and selection pressure protocols, and provides online monitoring of growth characteristics, passaging, cryo-conservation (thawing/freezing cycles), and hit selection criteria. As a fully integrated platform, the system directly integrates via transparent interfaces (APIs) with automation and analytics instruments, such as for tracking plating operations or cryovial preparation. Data from downstream assessment of hit clones using mini-bioreactors (e.g. ambr™) is captured and analyzed. In this way, the automated CLD process supports the selection of suitable cell lines for upscaling of bioreactor volumes - up to 100 liter scale and beyond. The CLD Platform also monitors product properties and quality by integrating and aggregating key analytics data, such as N-glycan profiles.