BioPharm International, March 2005

Feature Articles

Making Site-specific PEGylation Work

By James E. Seely, Ph.D. , Scott D. Buckel, Ph.D , Pat D. Green , Carl W. Richey

There are challenges aplenty in purification and analysis of PEGylated protein pharmaceuticals. Here are a variety of technical solutions, many concentrating on the chemistry of the linker.

Articles

Strategies for Extending the Life of Patents

By W. Murray Spruill, Ph.D., J.D. , Michelle L. Cunningham, Ph.D., J.D.

Pharmaceutical companies today are faced with increased costs for drug discovery and development and aggressive competition from generic drug companies. As research costs skyrocket, generic drug companies sit poised and ready to compete as soon as a patent expires. Maximizing patent term for successful products is an effective strategy for fending off generic competition and extending product lifecycle. This article will explore strategies for keeping a product under the patent umbrella.

New and Unknown Challenges Facing Biomanufacturing: An Editorial

By Uwe Gottschalk, PhD

Revisiting simple, robust, and controllable technology is the only way to overcome these challenges.

Scaling Down of Biopharmaceutical Unit Operations — Part 1: Fermentation

By Anurag S. Rathore, PhD , Raj Krishnan , Stephanie Tozer , Dave Smiley , Steve Rausch

Lot-to-lot variations between raw materials can greatly impact process performance.

Assessing and Managing Risks in a GMP Environment

By James L. Vesper, MPH

RARM procedures don't exist in a vacuum. For people to perform effective and useful RARMs, the process needs to be integrated with other GMP quality system elements and be proceduralized.

Columns and Departments

StreetTalk: Weak Dollar Could Give Foreign Biopharms a Boost — but Hold US Firms in Check

By Brian O'Connell

A tepid currency picture may cause biopharm companies to put the breaks on initiatives in places like information systems, research and development, and even hiring.

Regulatory Beat: Manufacturers Struggle with Vaccine Production and Supply

By Jill Wechsler

Bioterrorism legislation is in the works, but there will be a tough fight to enact added liability protections for manufacturers.

From the Editor in Chief—Consumers and Personal Responsibility

By Carol L. Fisher

This was the week for awards. The Academy Awards, which honored the film industry, captured the eye of millions worldwide. They were followed midweek by The Fourth Annual Top 25 Direct-to-Consumer (DTC) Marketers of the Year Awards. Sponsored by USA TODAY and DTC Perspectives magazine, these awards celebrated the accomplishments of 2004's most talented DTC pharmaceutical marketers.

Microarray Applications in Drug Discovery and Development

By Alan Dance

Patient stratification could accelerate drug expansion into new indications through faster, smaller, more definitive Phase IV trials.

Final Word: The Public Side of Science: The Cloning Three Ring Circus

By Tamara Zemlo

In this century, we are unlikely to face biomedical issues more complex and controversial than that of human cloning coupled with embryonic stem cell research. With the stakes so high — promises of cures and therapies for a host of devastating diseases and medical conditions set against impassioned disputes about when life begins — the cloning debate has evolved beyond the realm of scientific discourse and into the spotlight of public opinion. Unfortunately, this intense scrutiny, largely fueled by the media, has resulted in the misrepresentation of facts, and the twisting of scientific opinions as statements about cloning are often taken out of their appropriate context. In an attempt to counteract this damaging trend, The Science Advisory Board decided to poll its members about some of the most controversial aspects of the cloning debate.

Applying Lean Management in BioPharm Manufacturing

By Amir London

The BioPharma Operations Excellence Consortium, facilitated by Tefen Operations Management Consulting, continues to thrive, recently holding chapter meetings on two separate continents. The US East Coast Chapter met at Centocor's headquarters in Malvern, PA, while the European Chapter met at Sorono's facility in Vevey, Switzerland. Since its establishment in early 2002, over 45 leading biopharmaceutical companies have joined the forum, which operates on the basis of using the group's collective knowledge to drive each member company — and the industry as a whole — to world-class levels of operational effectiveness and efficiency.