Analytics

Articles

Although stability testing programs for small-molecule drugs and biologics are often perceived as similar, stability programs for biologics are far more complex.

Determining Shelf Life: Reading the Stability Testing Data

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.

Limitations and Advances in Dissolution Testing

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

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

Approaching Elemental Impurity Analysis

Agnes Shanley is senior editor of Pharmaceutical Technology.

Carcinogenic compounds have been found in a number of top-selling drugs, leading to recalls and bans. Preventing problems requires working closely with contract testing and development partners as well as API and other suppliers.

Collaborating to Prevent Genotoxic Contamination

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

The correct mix of excipients is crucial to the success of fast dissolving/orally disintegrating dosage forms.

Formulating for Convenience and Compliance

With new tests showing NDMA levels increase under normal storage conditions, FDA calls for removal of ranitidine products from the market.

FDA Removes Ranitidine Products from Market

Analytical solutions are improving for raw material testing, drug product release process development, and more.

Biopharma Analysis Benefits from New Technology and Methods

The Raised Stopper Inspection machine from Antares Vision verifies proper sealing of freeze-dried vials.

Finished Product Analysis