Drug Development

Articles

The authors review new regulatory expectations and describe potential approaches to accommodate excipient variability. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

Flexible Approaches to Accommodate Excipient Variability Using the Principles of QbD

The author proposes techniques, based on Six Sigma methods, for monitoring such processes to discover their airflow patterns and reduce opportunities for spillage.This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

Spillage Prevention and Airflow-Pattern Monitoring for High-Shear Process Operations

Angie Drakulich was editorial director of Pharmaceutical Technology.

A Q&A with the First Federation Chair, Patricia Rafidison.

IPEC Federation to Unify Excipient Usage and Standards

Thomas Paust is global director of marketing at Sartorius Stedim Biotech GmbH in Goettingen, Germany.

The authors describe the origins of single-use components and explain their application to aseptic processes. They also show how disposable devices have changed over time and offer a glimpse of the future.

The Evolution of Single-Use Technologies in Aseptic Processing

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Growth in the market for monoclonal antibodies, recombinant proteins, and vaccines creates new opportunities for drug companies and suppliers.

Moving to the Next Level in Biomanufacturing

Emerging markets remain an important element in the strategies of pharmaceutical companies and their suppliers.

Navigating the Global Pharmaceutical Supply Chain

Arthur J. Falk, PhD, is president and CDO of International Pharmaceutical Excipient Auditing (IPEA).

It's time to maintain a thorough traceable excipient trail.

Inside IPEC: Excipient Pedigree as a Supply Chain Tool

Michelle Hoffman, editorial director of Pharmaceutical Technology.

The second annual Pharmaceutical Technology Bioprocessing Survey offers a snapshot of the industry following 2009's megamergers.

Trends in Bioprocessing

Pharmaceutical Technology talked to drugmakers, equipment vendors, and service providers to learn more about the advantages and disadvantages of rapid microbial-detection methods.

An Overview of Rapid Microbial-Detection Methods

As contract manufacturers and drug companies meet at Informex, the stage is set for the latest in pharmaceutical chemical development.

APIs and Excipients