Development

Articles

Excipients are the hidden champions of drug development-no API works consistently without the right excipient. Pharmaceutical excipients, however, require stringent quality management. This article discusses how the supplier of pharmaceutical raw materials should take a central role in ensuring excipient quality.

A Supplier's Role in Ensuring and Improving Excipient Quality

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

As contract manufacturers and fine-chemical suppliers gather for CPhI/ICSE, effective strategies for technology differentiation are key in an increasingly competitive environment.

Building Technology Positions in API Manufacturing

A Q&A with Joe Cascone, director of potent pharmaceutical development at Metrics, moderated by Patricia Van Arnum. Discussion of the key considerations made in facility design, equipment selection, and operations to achieve desired levels of containment.

Achieving Containment in High-Potency Manufacturing: A Case Study for Solid Dosage Manufacturing

Tom Gelineau is Director, Business Development, at SAFC.

The market for HPAPIs is growing rapidly with the research industry's emphasis on oncology.

HPAPIs And Bioconjugates

Highly potent APIs (HPAPIs) represent a growing area of interest for the pharma industry. Mark Griffiths, CEO of Carbogen Amcis AG, explains why.

Highly Potent; Highly Challenging?

We're all familiar with traditional pills and medicines, but how about medicated chewing gum? Marc Ribe of Cafosa Gum explains how APIs can be incorporated into a novel dosage form that can aid patient compliance.

Chewing Over API Challenges

Angie Drakulich was editorial director of Pharmaceutical Technology.

Clarifying GMPs for excipients used as actives.

Atypical Actives Gain Attention

A Q&A with Brian Johnson, senior director of supply chain security at Pfizer, moderated by Patricia Van Arnum. Part of a special Ingredients issue.

Addressing Ways to Improve Supply-Chain Security: A Perspective from Pfizer

The authors provide an overview of methods for the quantitative determination of genotoxic impurities (GTIs) in active pharmaceutical ingredients.

The Determination and Control of Genotoxic Impurities in APIs

Recently, there have been many innovations in the latest techniques and technologies in API purification. In particular, the trend to single-use systems has had a significant impact on processes.