Editors' Picks of Pharmaceutical Science & Technology Innovations
To exert fine control over a manufacturing process, operators must have a detailed understanding of how that process works. Personnel also need means of verifying that their processes yield dosage forms of the appropriate strength, quality, and purity. This month's products illustrate ways in which analytical instruments can help in these and other applications. A new chromatography system from Waters provides results quickly and reduces solvent use. Malvern's Zetasizer µV lessens the importance of column calibration. A new probe from FOSS monitors cell growth in biopharmaceutical facilities.
Probe improves monitoring of cell-culture growthFOSS NIRSystems's Optimized BioProcess probes are available with a fixed or adjustable pathlength. The fixed-pathlength probe has a smooth surface and accumulates little debris, thereby facilitating cleaning in place. The adjustable-pathlength design enables users to adapt the probe for particular cultures or fermentations. FOSS can help clients optimize the pathlength for specific applications to allow sufficient flow through the gap and maximize sensitivity to low-level constituents.
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Chromatography system reduces solvent use
Instrument enhances protein characterization
Malvern has introduced its Zetasizer µV SEC-LS instrument, which provides the capability of a sensitive size-exclusion chromatography (SEC)–light scattering detector, and that of a research-grade batch dynamic light-scattering system. The incorporation of light scattering into the device improves protein characterization by SEC because it eliminates the reliance on column calibration and the interference from unexpected sample-column interactions. Dynamic light scattering also enables fast screening for sample aggregates that may indicate formulation problems or batch contamination.
The instrument contains Malvern's OmniFACE and OmniSEC software packages. The OmniFACE product enables operators to connect the instrument to third-party systems. Users thus can add light scattering to their SEC system's capabilities without buying a new system. The OmniSEC software is designed to allow scientists to convert raw data to results quickly.