In the Spotlight April 2011

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 growth

FOSS 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.

The Optimized BioProcess probe, designed for use in bioreactors, has a small diameter that allows it to fit into standard bioreactor ports. Operators can use the smallest BioProcess Probe in a disposable bioreactor after it has been autoclaved with a proper aseptic-insertion device. The probes have several source and detector fibers that improve its ability to detect the light-scattering cells present in the bioreactor with a good signal-to-noise ratio.

Optimized BioProcess probes FOSS NIRSystems www.foss-nirsystems.com

New Product Announcements

may be sent to New Products Editor, Pharmaceutical Technology, 485 Route One South, Building F, First Floor, Iselin, NJ 08830, fax 732.596.0005, ptpress@advanstar.com.

Chromatography system reduces solvent use

The Waters ACQUITY UPSFC system combines the advantages of sub-2-µm particle technology and the efficiency of supercritical-fluid chromatography. The system reduces run times by a factor of 10 and reduces solvent usage by as much as 95%. The system lets scientists conduct normal phase chromatographic separations using carbon dioxide as the primary mobile phase, rather than expensive and toxic solvents.

ACQUITY UPSFC system Waters www.waters.com

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.

Operators can change the sensitive Zetasizer µV instrument from flow mode to batch mode in seconds. The device's 8-µL flow cell is intended to virtually eliminate band broadening.

Zetasizer µV SEC-LS instrument Malvern www.malvern.com