There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Biologics Quality Control: The Growing Need for Accessible Proteomics

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Emerging Therapies Drive Analytical Advancements

Effective analytics will eliminate failures, deviations, and non-conformances.

 Analyzing Exabytes

Topic

Natalia Belikova, PhD, is analytical services director at SGS Life Sciences, Lincolnshire, IL.

Articles

Determination of sodium chloride level is critical for assessment of purity of yeast extracts. This case study demonstrates the validation of an ion chromatography method as a suitable analytical approach.

Determination of Sodium Chloride in Yeast Extract by Ion Chromatography

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

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Harmonization of best practices and regulatory requirements will enable developers to find the best stability testing approach.


Key Considerations in Stability Testing

LabVantage Solutions’ LabVantage 8.4 is the latest version of the company’s comprehensive laboratory information management system.

Lab Management Solution with Enhanced Data Privacy

HORIBA’s new analytical microscope simultaneously performs elemental analysis and optical observation without destroying samples.

New Microscope Combined Imaging Technology with High Speed Analysis

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

The TSKgel FcR-IIIA-NPR HPLC column from Tosoh Bioscience is a FcRγ affinity chromatography analysis column suited for the analysis of immunoglobulin G glycoforms.

Affinity Chromatography Analysis Column for Antibody Drugs

The companies will develop a software-connected pipetting system for improved reproducibility and traceability in life-science laboratories.

Andrew Alliance, Sartorius to Collaborate on Pipettes

Kieran O’Connor is Analytical Science and Technology senior chemist at SK biotek, Ireland, kieran.oconnor@sk.com. (formerly Bristol Myers Squibb)

John Wasylyk is senior principal scientist at Bristol-Myers Squibb, USA; john.wasylyk@bms.com

Bob Wethman is senior research scientist II at Bristol-Myers Squibb, USA

Ming Huang is senior research investigator I at Bristol-Myers Squibb, USA

Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing. 

Spectroscopy Facilitates Lean Analysis

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

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

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes