Monitoring Data Capabilities
Managing and interpreting process data generated during development can be a major bottleneck in deciding on key quality attributes. Electronic laboratory notebooks (ELNs) and laboratory information management systems (LIMS) fall short on several fronts. Although meta-tagging and collaboration are common components of modern ELNs, the software essentially creates electronic versions of paper documents. LIMS, on the other hand, are primarily for sample tracking.
Hans Peter Fischer, head of Genedata Biologics, described a new approach to managing the data deluge during development. Genedata Biologics™, part of the Genedata software suite for life sciences research and development, is an enterprise system that supports biologics R&D from inception through development-stage analytics, production, and purification.
While Genedata provides a central registration system for all molecules and samples, its principal benefits are the ability to capture, manage and analyze data, and integrate sample management with analytic data. “Integrating data about molecules, samples, and analytics is the best way to describe this software,” Fischer said. “But it’s neither an LIMS nor an ELN.”
Like more familiar laboratory software, Genedata Biologics directly connects with analytical workstations and automated monitoring equipment, at scales ranging from shake flasks to 200 L bioreactors.
Genedata also helps developers uncover trends. For example, during a development project a team may wish to optimize expression levels of three different CHO lines based on media, feed, transfection protocol, and culture time. “Our system provides a systematic, structured way to store data collected during development of your three different cell lines, and then systematically compare product quality based on key analytics. Everything is tracked,” Fischer reported. The conditions and quality attributes may then be applied during scaleup.