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 ÁV 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
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Chromatography system reduces solvent use
The Waters ACQUITY UPSFC system combines the advantages of sub-2-Ám 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 ÁV 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 ÁV instrument from flow mode to batch mode in seconds. The device's 8-ÁL flow
cell is intended to virtually eliminate band broadening.
Zetasizer ÁV SEC-LS instrument Malvern www.malvern.com