Analytics

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Articles

Mass spectrometry and automation are growing in importance for protein characterization, but further improvements are still needed.

Evolving Analytical Technology Unravels Protein Characteristics

Phil Borman, DSc, has served in multiple quality-related roles at GlaxoSmithKline; as of April 2021, he is senior fellow and director of product quality.

Timothy Schofield is owner and consultant, CMC Sciences, LLC;

David Lansky, PhD, is president, Precision Bioassay, Inc.

A well-chosen replication strategy can effectively reduce the uncertainty for an analytical method, enabling appropriate decisions regarding pharmaceutical quality. 

Reducing Uncertainty of an Analytical Method through Efficient Use of Replication

The new filters extend column life and reduce contamination while simplifying sample preparation.

Pall Introduces Acrodisc Syringe Filters with Universal, Water-Wettable PTFE Membranes

The new chromatography columns provide enhanced separation for high order aggregates and macromolecules.

Tosoh Bioscience Introduces TSKgel UP-SW Aggregate UHPLC/HPLC Columns

Editor of Pharmaceutical Technology Europe

Instrumentation advancements over the past 30 years have certainly enabled greater efficiency in pharma development and analysis despite slow adoption by the industry.


Tooling Up for Pharma

The LenS3 Multi-Angle Light Scattering (MALS) detector, presented at Pittcon 2019 in Philadelphia, PA, uses a new approach for measuring molecular weight and radius of gyration of synthetic polymers, polysaccharides, proteins, and biopolymers.

Tosoh Bioscience Introduces New MALS Detector at Pittcon 2019

Luke Deters is director Biologics at Catalent Pharma Solutions, Kansas City, Missouri, USA.

HPLC coupled with charged aerosol detection is a suitable analytical technique to quantitate and characterize polysorbate-80 in therapeutic products; allowing quality assessment of raw material, content confirmation during manufacturing, and monitoring product stability.


Quantification and Characterization of Polysorbate-80 in Protein Formulations

Daniel N. Hayes is associate principal scientist at Cambrex High Point Analytical Research and Development.

Investigation of peak purity failure during HPLC method validation led to discovery of a co-eluting impurity under the main peak. Spectral analysis, including three-dimensional modelling, was used to characterize the peak, leading to the development of a new HPLC method for analysing impurity content.

Utilizing Spectral Analysis in HPLC Diode Array to Discover Impurities

Leveraging vast quantities of analytical data requires digitalization and platform integration. 

Paradigm Shift for Data Analysis and Interpretation

The company has built a fit-for-purpose liquid chromatography–mass spectrometry (LC–MS) system to streamline analytical monitoring tests for biopharmaceuticals.

Bio/Pharmaceutical Analysis, HPLC/UHPLC