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Sep 1, 2013 (Vol. 33, No. 15)

Exploiting Cells’ Electrical Behavior

  • 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.

  • In the Beginning

    Click Image To Enlarge +
    SAFC’s raw material characterization program encourages the screening of raw materials using near-infrared and Raman sensing devices.

    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 employs 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 finished 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 ultra-high performance liquid chromatography-mass 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 process-related response we’re looking for.”

  • Rapid, Reliable Sandwich-Type Assays

    Process analytic technology implementations have been slow to achieve real-time analysis and monitoring for high-level parameters such as protein titer and host cell contaminants. These critical parameters are typically analyzed by HPLC or sandwich-type assays, both of which are time consuming and, even in automated formats, prone to human error.

    Uppsala Sweden-based Gyros has introduced the Gyrolab™ xP, which miniaturizes, standardizes, and automates up to 112 sandwich assays and delivers results in about one hour. Gyrolab enriches monitoring from discovery through clone selection, media and process development, scaleup, and manufacturing.

    The system is based on an automated liquid-handling system that uses eight needles for sample transfer and two for reagents. Instead of running the assays in plates through sequential addition of reagents, the analysis cassette consists of a compact disk (CD) containing 112 microchanneled analysis pathways, including a 15 nL streptavidin bead column. After samples are introduced, the CD spins and samples move through the channels and column through centripetal force. When the assay is completed, a robotic arm moves the CD to a reader, which generates the result.

    According to North American marketing manager Joy Concepcion, Gyrolab provides significantly greater dynamic range (3–4 log) compared with traditional sandwich assays (about 1.5 log). “Traditional ELISA can take an entire day. Results that fall outside the assay’s dynamic range can stretch the time out to a week. With Gyrolab, 90% of results fall within the system’s detection capabilities, which translates to less re-work.”

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