May / June 2015

May / Jun 2015 Cover


Celebrating Purpose, Intent and Innovation

Guest Editorial: by John E. Bournas, President and CEO, ISPE

FOYA Category Winners to be Honored at 2015 ISPE Facility of the Year Awards Banquet

Managing the Design of a Single-Use Facility for Biomanufacturing: Lessons Outside the Traditional Project Management Box

by Jeff Odum, CPIP. This article will identify many key design issues of an SUS and provide experienced-based guidance on how to address them.

Tests on Rouging and Experiences Dealing with Rouging in Pharmaceutical Production (Part 2 of 3)

by Thomas Blitz, Ernst Felber, Robert Haas, Birgit Lorsbach, Andreas Marjoram, Roland Merkofer, Tobias Mueller, Nathalie Schuleit, Marc Vernier and Thomas Wellauer
Part 2 of this article describes tests and practical experiences in rouging formation and the influence of rouge coatings on cleaning efficiency.

Using Control Charts To Evaluate Pharmaceutical Manufacturing Process Variability

by Daniel Y. Peng, Robert Lionberger, Alex Viehmann, Karthik Iyer and Lawrence X. Yu
This article presents the discussion on the use of control charts to evaluate pharmaceutical process variability.

Using Handheld Raman Spectroscopy to Reduce Risks in Materials Used for Manufacturing

by Katherine A. Bakeev
This article presents the discussion on minimizing risks in quality of pharmaceutical manufacturing using Raman spectroscopy, which provides a rapid, reliable means of testing in many different environments in manufacturing, including the loading dock.

Scientific and Regulatory Considerations For Implementing Mathematical Models In The Quality By Design (QbD) Framework (Part 1 of 2)

by Theodora Kourti, John Lepore, Lorenz Liesum, Moheb Nasr, Sharmista Chatterjee, Christine M.V. Moore and Evdokia Korakianiti
This article is the first of a two-part series and presents points to consider for building and using models in the regulated pharmaceutical industry and offers examples of how models can play a part in the Quality by Design (QbD) framework.

Issues With the Safe Handling of Antibody Drug Conjugates (ADCS)

by Peter J. Marshall, Justin Mason-Home, John P. Farris, Erica L. Dahl and Fredrik Waern
This article reviews the significance related to high toxicity, and the complexity in determination of (bio) chemical exposure hazards and risks associated with ADC-related activities at all scales. High level approaches to mitigate and control these risks are proposed for consideration with the objective of establishing safe working environments and practices in a systematic, scientific manner, avoiding emotional or poorly informed responses which may, at the extremes, either create untenable risks of exposure or an overreaction to the extreme toxicity of the materials involved.