Development

Articles

Roquette has launched excipients PEARLITOL CR-H and PEARLITOL 200 GT.

Roquette Launches Next-Generation Direct Compression Solutions

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

Numerous benefits will eventually lead to large-scale applications in pharmaceutical manufacturing. 

Electrochemistry for API Synthesis

Roquette’s acquisition of Crest Cellulose is designed to reinforce its presence in India and other countries in Asia.

Roquette Acquires Indian Excipient Manufacturer

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

Pharmaceutical Technology spoke with Andrew Anderson, Global Head Strategic Account Management and Mary Todas, Director Technical Development and Regulatory Affairs, both with Pfizer CentreOne, about best practices for API quality. 

Industry Perspectives on Quality–A Conversation with Pfizer CentreOne

Pharmaceutical Technology spoke with Niamh Lynch, Executive Director, Global Head of Quality, Lonza Small Molecules, Basel about best practices for API quality and the impact of the nitrosamine contamination situation.

Industry Perspective on API Quality–A Conversation with Niamh Lynch of Lonza Small Molecules

The nitrosamines contamination in “sartan” drugs emphasized the importance of risk assessment in the manufacture of active pharmaceutical ingredients.

What Goes Wrong When API Quality is Compromised?

Brian Carlin is global manager of pharmaceutical research and development at FMC-Biopolymer (Princeton, NJ).

George Collins is vice president, Vanderbilt Chemicals LLC. 

R. Christian Moreton, PhD, is vice-president of pharmaceutical sciences at Finnbrit Consulting and a member of Pharmaceutical Technology’s editorial advisory board.

David Schoneker is president, Black Diamond Regulatory Consulting, LLC

Jennifer Putnam is AR&D supervisor II, Perrigo

Joseph Zeleznik is manager, technical & regulatory affairs at Meggle USA.

Katherine Ulman is a Global Regulatory Compliance Manager at Dow Corning.

Stacey Bremer is Director, Product Stewardship Medical at Celanese.

This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.

Mitigating the Risk from Excipient Variability

Andrew James is marketing director, Ellutia Limited.

Screening for apparent total nitrosamine content with a thermal energy analyzer offers a rapid way of identifying contaminated drug products.

Detecting Apparent Total Nitrosamine Content in Pharmaceutical Drugs

Pharmaceutical Technology Europe spoke with representatives from the European Directorate for the Quality of Medicines & Healthcare (EDQM) about API quality from their perspective.

Ensuring API Quality—The EDQM Perspective

Pharmaceutical Technology spoke with Ed Gump, VP Small Molecules at the US Pharmacopeia (USP) about API quality from the standards perspective. 

APIs and Excipients