Analytics

Articles

Synthetic biology can help researchers circumvent the challenges of traditional methods of antibody generation.

Antibody Development Made Easier with Synthetic Biology

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

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

Biopharma Analysis Benefits from New Technology and Methods

Complex protein structures pose analytical challenges that can be addressed by advanced mass spectrometry technologies and workflows, which can be used to comprehensively characterize them.

How Advanced Mass Spectrometry Technologies and Workflows are Delivering Comprehensive Protein Characterization

Past mistakes and misstatements have adversely influenced industry decontamination practices with vapor phase hydrogen peroxide, and this article endeavors to clarify the process.

Real-World Vapor Phase Hydrogen Peroxide Decontamination

The aim of this study was to prepare taste-masked drug-resin complex using ion exchange resin Kyron T-134.

Development of Taste-Masked Oral Reconstitutable Suspension of Cetirizine Dihydrochloride

GE Healthcare Life Sciences and Advanced Solutions Life Sciences (ASLS) are partnering on 3D-printing of tissues that can be used for discovery and cytotoxicity testing.

GE Healthcare and ASLS Collaborate on Equipment for 3D Printed, Vascularized Tissue

Elizabeth Joseph is research scientist II, BioPharma Solutions at Baxter Healthcare Corporation.

The author provides an overview of common residual moisture methods for lyophilized drug products and key points to consider during method selection and method development.

Residual Moisture Determination in Lyophilized Drug Products

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

In this article, experts discuss the fundamentals of dissolution testing and highlight the challenges that are surfacing as a result of the increasing numbers of poorly soluble molecules entering the development pipeline.


The Fundamentals of Dissolution Testing

Marion Chatfield is a manager in Statistical Sciences at GlaxoSmithKline (Hertfordshire).

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.

Fumiko Tamura is associate manager, GSK, CMC Regulatory Affairs, Tokyo, Japan

Hatsuki Asahara is department manager with GSK, CMC Regulatory Affairs, Tokyo, Japan

Adam Watkins is scientific leader, GSK, product development and supply, David Jack Research Centre, Ware, UK.

Validation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies. 

Risk-Based Intermediate Precision Studies for Analytical Procedure Validation

Anna Novikova, PhD, is a process analytical technology scientist at Fette Compacting, anovikova@fette-compacting.com.

At-line NIR measurements can replace a laboratory HPLC measurement for API content in oral solid-dosage drug manufacturing.

Analytical Method Development