PAT and Green Chemistry: The Intersection of Benign by Design and Quality by Design

by Berkeley W. Cue, John Berridge, Julie B. Manley
This article will illustrate the application of Process Analytical Technology (PAT) as an important contributor to the “triple bottom line,” a measure of a company’s economic, environmental, and social performance, and the sustainability of the pharmaceutical industry.

Introduction to PAT Data Management Solutions

by Mark N. Reed
This article discusses the critical requirements for a Process Analytical Technology (PAT) data management solution and how these requirements contribute to the successful operation of the PAT solution.

Considerations for Transferring a Bulk Freeze-Drying Process from a Glass Container to a Tray

by Yves Mayeresse, Vinciane de Cupere, Romain Veillon, Joseph Brendle
This article presents the transfer of a freeze-drying process from a glass bottle to a freeze-drying tray.

Clinical Manufacturing Efficiency

by Beth H. Junker, Kay Hunsberger, Vicky Griffin, Kent Hamaker, Carl Holz, Amy Caparoni, Kelly Kistler, Jeffrey Graczyk, Marshall Gayton
This article presents a description of an operational effectiveness project to improve clinical material manufacturing efficiency of a biologics pilot plant. It utilizes lean and Kaizen principles to identify root causes, then brainstorm/evaluate potential solutions.

Using GAMP 5 for Rapid Deployment

by Markus Roemer, Hermann Schaefer
This article presents the implementation of a risk-based approach into a supplier’s Software Development Workflow and Product’s Release Management according to GAMP^® 5.