Development

Articles

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. 

Ensuring API Quality—A Pharmacopeia Perspective

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

Lack of toxicity data and poor physicochemical properties must be overcome.

Challenges to Formulation Development for Highly Potent APIs

The right processes used with the right excipient combinations address evolving formulation needs.

Development of Coprocessed Excipients

Lubrizol has launched Apisolex technology to improve solubility and simplify the manufacturing of parenteral drug products.

Lubrizol Launches Apisolex Technology 

New report released by USP offers a look into API supply-chain vulnerabilities.

USP Medicine Supply Map Reviews Global API Manufacturing 

ImmunoGen and Eli Lilly and Company have entered into an agreement that gives Lilly exclusive rights to research, develop, and commercialize ADCs designed for targets selected by Lilly from ImmunoGen’s camptothecin technology.

APIs and Excipients