Editors' Picks of Pharmaceutical Science & Technology Innovations
FDA's emphasis on building process understanding has brought new importance to analytical technology. Drugmakers traditionally have used instruments to monitor the quality of their final products, but analytical technology also can help personnel understand and control process parameters, and thereby reduce the occurrence of out-of-specification results. This month's products illustrate ways in which analytical instruments assist the drug-manufacturing process. Software from NanoSight helps employees track nanoparticle concentrations. An instrument from Roche ensures that conditions are appropriate during protein production. Emerson Process Management's liquid analyzer aids producers of water for injection.
Software measures nanoparticle concentrations
The new version of NanoSight's Nanoparticle Tracking Analysis (NTA) software platform counts 30–1000-nm particles in suspension and measures their concentration. The system rapidly characterizes the size and concentration of nanoscale protein aggregation in the presence of a large, nonaggregated protein population. Users can distinguish labeled particles from each other using the technique's fluorescence mode. The software measures the concentration of virus or viruslike-particles more quickly than the plaque-assay technique does, according to Patrick Hole, head of development at NanoSight.
Nanoparticle Tracking Analysis NanoSight www.nanosight.com
Unlike other particle-sizing software, the NTA software gives the user a visual validation of the source of the raw data, thus allowing him or her to identify potential measurement problems easily. The software complies with 21 CFR Part 11 by protecting recorded data from tampering, attributing data to individual users, and restricting certain functions to supervisors.
Bioprocess analyzer ensures proper protein production conditions
Roche's Cedex Bio Bioprocess Analyzer is a continuous random-access instrument that enables the safe and reliable determination of chemical and biochemical parameters in aqueous solutions. The compact desktop system is designed to perform metabolite screening and substrate analysis of bioprocesses. Its testing capabilities include photometric testing and electrolyte testing. The instrument allows users to measure as many as 14 parameters simultaneously, out of 28 programmable tests, per sample. The unit also enables continuous loading and unloading of diverse cup types.
Cedex Bio Bioprocess Analyzer Roche www.roche.com
Liquid analyzer captures measurement data
Emerson Process Management's Rosemount Analytical Model 56 dual-input liquid analyzer performs a range of online measurements. The analyzer includes a high-resolution, full-color LCD screen that displays process variables and an on-screen user manual. The unit also provides diagnostics, extensive full-color trend graphics, advanced control capabilities, and digital communications. Data and event-logging capacities provide extensive on-board data storage. The instrument captures measurement data for both channels every 30 seconds for 30 days that can be downloaded to a USB memory device.
Rosemount Analytical Model 56 unit Emerson Process Management www.emersonprocess.com
The Rosemount Analytical Model 56 measures pH and dissolved oxygen. The instrument can ensure that water produced for water-for-injection systems is produced consistently and complies with the US Pharmacopeia.