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Bioprocessing pretty much all process analytical technology (PAT) methods available today—requires systems capable of handling large, disparate datasets and analyzing the data in a way that provides real process guidance." The group at Bend Research has resolved multiple cell populations within the context of apoptosis. Other groups, Dr. Graham said, have reported changes in cell populations associated with metabolic changes, cell size, membrane composition, and cell morphology. ploys multivariate analysis to uncover spectral properties that correlate with quality attributes in culture medium as well as raw ingredients like plant hydrolysates. "These methods are fast and noninvasive," Dr. Sharma said. "Although they don't provide the depth of analysis of bench techniques, they're extremely attractive because of their speed. Many of our customers are interested in using the same techniques for their incoming raw materials, which include our fnished products." Rapid spectroscopy generates spectra which, with the proper analytical approach, can generate quality "signatures." But they cannot pick up trace components. So, in addition to rapid methods, Dr. Sharma's group employs more traditional ultrahigh performance liquid chromatographymass spectrometry (UHPLC-MS) to probe deeper into suspected quality issues for which Raman and NIR serve as screens. "Multivariate analysis is quite powerful," Dr. Sharma commented. "It can crunch multi-dimensional data and give you something meaningful, for example, the correlation between raw material characteristics and cell growth or productivity of antibody. We can tie in data we collect to whatever processrelated response we're looking for." 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 purifcation. While Genedata provides a central registration system for all molecules and samples, its principal benefts 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 fasks 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. In the Beginning One can construct a decent argument for monitoring bioprocesses at the raw-ingredient stage. That idea is part of an initiative at SAFC, begun in 2009. The company's Raw Material Characterization (RMC) program seeks to screen raw materials analytically and biologically, and to do so rapidly using near-infrared (NIR) and Raman sensing devices. Principal scientist Chandana Sharma, Ph.D., notes that investigators may then em- Single-Use Sensors TruFluor and TruTorr | Excellence in bio-processing measurement Secure the integrity of your single-use container Measure critical process parameters in real-time Acquire data immediately with pre-calibrated sheaths Reinforce cGMP compliance with plug-in loop validators Trust the results with drift-free TruFluor & TruTorr technology Make your process excellent. Toll Free +1 800 598 9515 | Europe +41 81 641 2000 | Asia +65 8322 8128 Finesse.com | © 2013 Finesse Solutions, Inc. Genetic Engineering & Biotechnology News | GENengnews.com | September 1, 2013 | 41