Manufacturing

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Angie Drakulich was editorial director of Pharmaceutical Technology.

Articles

Leading experts share insight on the current and future direction of process analytical technology. This article contains bonus online material.

PAT: A New Dawn for Drug Product Quality

Endotoxin removal from a finished product is a major challenge for biopharmaceutical manufacturers; particularly as all endotoxin removal methods have operational limitations and may result in loss of protein.

Removing endotoxin from biopharmaceutical solutions

Drugmakers have the common goal of manufacturing safe and sterile pharmaceutical products and understand that the filtration process is a critical means of achieving this goal. Preuse filter-integrity testing provides evidence that a filter will perform correctly, has the right pore size, and has been installed correctly.

The Debate over Preuse Filter-Integrity Testing

A look at the true cost-drivers of cell-culture production.

Debunking the Bottleneck Myth

Theodore H. Meltzer is principle of Capitola Consultancy.

Jean-Marc Cappia is vice-president of marketing for fluid management technology at Sartorius Stedim Biotech FMT, Aubagne, France.

The authors discuss current and future disposable technologies and outline the validation and qualification steps that would be required for a possible disposable process stream.

Disposable Components in Aseptic Processing

Yoshi Izumi is executive vice-president at Shibuya Hoppmann Co., a subsidiary of Shibuya Kogyo, Co. Ltd.

James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, akainckc@aol.com.

The authors review the role of automation in aseptic processing and describe their experience in implementing advanced technologies, including the use of isolators and robotics.

The Impact of Automation on Aseptic Processing

The spotlight on the biopharmaceutical industry is intensifying, as recently evidenced by Pfizer's (New York) ongoing acquisition of Wyeth (Madison, NJ), which was initiated partly to reduce the former's dependence on small-molecule drugs.

The Shape of Biopharmaceutical Facilities to Come

Ultra high performance liquid chromatography is advantageous in a contract laboratory because it is faster, more sensitive, and relies on smaller volumes of organic solvents than HPLC.

Ultra High Performance Liquid Chromatography in the Contract Manufacturing Environment

Sanjay Garg, PhD, is an associate professor at the School of Pharmacy, University of Auckland, Auckland, New Zealand, and a member of the Pharmaceutical Technology Editorial Advisory Board.

A book about pharmaceutical analysis engages the reader with history and unexpected asides.

A Peak in Mass-Spectrometry Literature

A well-balanced guide to industrial bioseparations provides valuable information.

Equipment