Automation and real-time monitoring show promising results.

Limitations and Advances in Dissolution Testing

Paperless data systems can improve efficiency and quality

Tracking Raw Materials

Pandemic spurs lab data integrity worries.

Cybersecurity Risks in Laboratories

Topic

Articles

A shortage of pipette tips has been attributed to several factors, including the COVID-19 pandemic.

Pipette Tip Shortage Hinders Bio/Pharmaceutical Development and Testing

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

This article introduces a practical approach to determining the best estimate for probability of passing uniformity of dosage units (content uniformity) using probability vs. lot coverage charts and tables constructed using simulated probability and lot coverage (LC1) data. 

Determining the Best Estimate of Probability of Passing Multiple Stage Tests:  Part 1–Content Uniformity

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

Editor of Pharmaceutical Technology Europe

Despite its importance in drug development, dissolution testing still has some limitations, but advances in automation and real-time monitoring are producing promising results.

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

Peter Zipfell is product marketing specialist, CMD Software, Thermo Fisher Scientific.

The move to continuous manufacturing and Pharma 4.0 is resulting in a more data-driven approach to bio/pharma development. Enabling this approach are innovative data systems that can help users improve product quality while facilitating audit-trail review. First used with chromatography, they are now being applied to mass spectrometry.

Strengthening Data Integrity and Traceability

Timothy Curran is executive director in process chemistry, Vertex Pharmaceuticals.

J.P. Bercu is senior director in nonclinical safety and pathobiology, Gilead Sciences.

Managing the Risk of Nitrosamine Impurities

Validation for SaaS LIMS, advance analytics, and cybersecurity features announced during Pittcon virtual press conference.

LabVantage Announces Product Enhancements

Jennifer Markarian is manufacturing editor of BioPharm International.

Integrated, paperless data systems can improve efficiency and quality.

Analytics

Limitations and Advances in Dissolution Testing

Tracking Raw Materials

Cybersecurity Risks in Laboratories