Quality/GMPs

Hari Narayanan, PhD, is product marketing manager at Thermo Fisher Scientific.

Articles

Fully automated enzyme analysis can ease a persistent bottleneck in biocatalyst development for bio/pharmaceutical applications.

Advancing Enzyme Analysis

Feliza Mirasol is the science editor for 

Confounding signals pose challenges to analytical methods necessary for managing residual impurity removal in biotherapeutic manufacturing.

Managing Residual Impurities in Complex Biotherapeutics

Glycosylation monitoring has been heavily dependent on manual processes, but the automation of sample preparation streamlines the overall workflow.

Streamlining Glycosylation Monitoring through Automation

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of BioPharm International's Editorial Advisory Board.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about the difference between the roles of quality assurance and quality control.

Frequently Asked Questions About Quality Control vs. Quality Assurance

Editor of Pharmaceutical Technology Europe

Jordi Serrat, Product & Technology Director, Azbil Telstar talks about the role of disruptive and digital technologies in aseptic processing.

Evolution of Aseptic Processing: INTERPHEX Keynote Part 5

Rafael Beaus, Global Consultancy Manager, Azbil Telstar, discusses Annex 1 and trends in aseptic production.

Evolution of Aseptic Processing: INTERPHEX Keynote Part 4

Luke Stockhausen, Lead Process Engineer, CRB, talks about technological advances, processing line changes, and new solutions to overcome challenges in aseptic processing.

Evolution of Aseptic Processing: INTERPHEX Keynote Part 3

Richard Denk, Senior Consultant Aseptic Processing and Containment, SKAN AG, discusses the evolution of aseptic processing with a particular focus on isolators.

Evolution of Aseptic Processing: INTERPHEX Keynote Part 2

Patrick Nieuwenhuizen, Senior Manager/Consultant, PharmaLex, discusses changes to regulatory requirements, quality risk management, audits, and operational considerations of aseptic processing.

Evolution of Aseptic Processing: INTERPHEX Keynote Part 1

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

COVID-19 created challenges for quality control departments. How have the lessons learned from the pandemic influenced the way companies use technology to perform quality-control procedures?

Quality Control/Quality Assurance