Drug Development

Articles

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

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

Further advances in construct design and manufacturing scalability are still needed.

Progress in the Development of CAR NK-Cell Therapies

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

Novasep-PharmaZell will increase API production capacity at its Mourenx site with €7.3M investment. 

Novasep-PharmaZell Invests €7.3M to Increase API Production Capacity

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

Ensuring API Quality—A Pharmacopeia Perspective

VeriSIM Life and Mayo Clinic are collaborating to develop new promising drug candidates.

VeriSIM Life and Mayo Clinic Team Up to Co-develop New Therapies

NRG Therapeutics and Domainex aim to develop novel small-molecule drugs to treat neurodegenerative disorders, such as Parkinson’s disease.

APIs and Excipients