Analytics

Aaron M. Robitaille is senior product marketing manager with Thermo Fisher Scientific.

Brandon J. Bills is product manager, Thermo Fisher Scientific.

Articles

Intelligent analytical tools detect impurities to help ensure the quality of small-molecule drug ingredients.

Stepping Up the Search for Unknown Impurities

Mark Rogers, PhD, mark.rogers@sgs.com, is the global scientific director for the SGS Health Science Drug Development group.

New challenges arise in extractable and leachable studies for cell and gene therapy products.

Preparing for the Unexpected: E&L Studies in Biopharma

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

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

Brian Marquardt, PhD, is founder and CEO of MarqMetrix, Inc., and director of the Center for Process Analysis and Control (CPAC) at the University of Washington.

Raman spectroscopy delivers real time, non-destructive process insights for critical process parameters to monitor pharmaceutical manufacturing.

Raman Detects Pharma Processing Fingerprints

Garima Thakur is a graduate student in the Department of Chemical Engineering at the Indian Institute of Technology New Delhi.

Anurag S. Rathore is a professor in the Department of Chemical Engineering at the Indian Institute of Technology Delhi and a member of BioPharm International's Editorial Advisory Board, Tel. +91.9650770650, asrathore@biotechcmz.com.

The need for real-time monitoring and control has spurred the development of new analytical tools.

Near Infrared Spectroscopy as a Versatile PAT Tool for Continuous Downstream Bioprocessing

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

Common approaches to analyze elemental impurities for compliance with regulatory requirements are robust but still have some limitations.

Approaching Elemental Impurity Analysis

Having a clear and detailed understanding of exactly what a biomolecule entails is essential for therapeutics development.

Protein Characterization Can Support Regulatory Submission

The £500,000 (US$686,294)-investment in mass spectrometry support will accelerate biologics development and approval.

Almac Invests in Expanding Global Biologics Testing Solutions

Enhanced sensitivity and ultra-high detection speed provide improved robustness and operability.

Bio/Pharmaceutical Analysis Techniques