In the Spotlight - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

In the Spotlight
New product reviews for October 2011 focusing on analytical instrumentation.

Pharmaceutical Technology
Volume 35, Issue 10, pp. 26

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


Nanoparticle Tracking Analysis NanoSight www.nanosight.com
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.

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


Cedex Bio Bioprocess Analyzer Roche www.roche.com
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.

Liquid analyzer captures measurement data


Rosemount Analytical Model 56 unit Emerson Process Management www.emersonprocess.com
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.

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.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Source: Pharmaceutical Technology,
Click here