Analytical Instrumentation

There are many different approaches for assessing process parameter criticality, and assessing which process parameters have a significant impact on critical quality attributes (CQAs) is a particular challenge. Including an unimportant process parameter as a critical process parameter (CPP) in a control strategy can be detrimental. The authors present a statistical approach to determine when a statistically significant relationship between a process parameter and a CQA is large enough to make a practically meaningful impact (i.e., practical significance).

The advanced capillary electrophoresis system, Maurice, from ProteinSimple is used for the quantitative analysis of identity, purity, and heterogeneity profiles of biopharmaceuticals.

Researchers describe a new method to compare the higher-order structure of a reference biologic with its proposed biosimilar product candidates.

Today’s analytical laboratory equipment reflects the realities of downsizing, outsourcing, and the need for speed.

Time and sensitivity are essential for analytical technologies in all phases of biopharma development.

The European Directorate for the Quality of Medicines & Healthcare announces the publication of a chemometric methods chapter in the European Pharmacopoeia.

The European Pharmacopoeia rewrites in its general chapter on Raman spectroscopy.

Sensaphone's monitoring system provides low-cost, 24/7 remote monitoring of unattended freezers and coolers.

An ultraviolet light (UV) spectrophotometer system from Hanson Research automatically handles samples for pharmaceutical dissolution and diffusion testing.

The Prominence-i LC-2030 LT is a new model of Shimadzu’s i-Series integrated high-performance liquid chromatograph and ultra high-performance liquid chromatograph systems.

Shimadzu’s Nexera MP UHPLC Front End system for LC/MS is perfect for LC/MS analysis conducted in pharmacokinetics and synthesis stages in drug detection processes. read more

KnowItAll spectroscopy software from Bio-Rad Laboratories corrects differences in spectra data.

Charles River offers the Endosafe nexgen-PTS endotoxin testing system.

Copley Scientific’s new Vertical Diffusion Cell Test System Model HDT 1000 comprises a compact unit with 10 test stations that enables the precise control of test conditions.

The Nexera UC Unified Chromatography System from Shimadzu Scientific Instruments was recognized with an R&D100 award.

Dynamic powder testing and measurement of bulk powder properties can complement shear cell testing to identify the causes of poor hopper performance in solid-dosage drug manufacturing.

Mettler Toledo Thornton’s 7000RMS delivers on-line, real-time, continuous measurement of microbes and inert particles in purified pharmaceutical waters.

Problems in an induction-sealing process, such as untorqued or crooked caps, can be identified and corrected in real time using dynamic thermal imaging.

Shimadzu’s new LCMS-8060 is designed to push the limits of LC/MS/MS quantitation for applications requiring the highest sensitivity and robustness while delivering a meaningful solution for routine LC/MS/MS analyses.

Shimadzu and Hanson Research partner on pharmaceutical testing instrument integration.

A rheometer and powder flow tester can measure how pharmaceutical materials, such as powders from a hopper, flow.

Mettler Toledo’s RX-10 Reactor Control automates jacketed lab reactors and controls thermostats, stirrers, and pumps.

Flow chemistry systems from Dolomite Microfluidics can be configured to suit different applications.

Shimadzu Scientific Instruments reports its EDX-7000/8000 spectrometers are compliant with electronic signature regulations.

The SFT - HPR-Micro Reactor from Supercritical Fluid Technologies introduces a is a pressure reactor for small batch reaction chemistry.

A high-pressure lab homogenizer from GEA for product development ensures efficiency and safety.

Shimadzu’s newLCMS-8060 is designed to push the limits of LC/MS/MS quantitation for applications requiring the highest sensitivity and robustness while delivering a meaningful solution for routine LC/MS/MS analyses.

Shimadzu’s LCMS-8060 triple quadrupole mass spectrometer is designed for LC/MS/MS quantitation of highly sensitive applications.

Shimadzu has introduced the i-series of integrated HPLC and UHPLC systems. The analyzers meet the needs of any analytical environment with high speed, outstanding performance, maintainability and economic efficiency.

Charles Rivers strengthens its endotoxin testing and bacterial identification detection capabilities with the addition of Celsis’ products.