BioPharm International-07-01-2002

Outsourcing ? A Collaborative Plan

July 15, 2002

by Gary Vinson, and Barbara Carter-Hamm, Magellan Pharmaceutical Development Pharmaceutical companies rely on outsourcing organizations that anticipate and prepare for client audits. Such contractor companies become collaborative partners. A technically proficient contract organization understands client needs, knows the regulatory environment in which drug development takes place, and sees a client audit as a professional opportunity to show its expertise.

by Jim Miller, PharmSource Information Services, David S. Zuckerman, Customized Improvement Strategies, and Michael B. Higgins, Belgard Consulting A sponsor?contractor team can prevent relationship failures by using a good team strategy to overcome organizational, cultural, and functional boundaries.

by Ron Levine, Coast Writing

by Timothy N. Breece, Ellen Gilkerson, and Charles Schmelzer, Genentech, Inc.

by April Davis, Inforonics, Inc. Increasing workplace efficiency, saving time, reducing costs, and retaining, exchanging, and reusing knowledge are a few of the reasons companies introduce knowledge management systems. But, if the four pillars of success ? content, process, culture, and technology ? are ignored, the tools may be shoved to the back of the laboratory closet.

by Jill Wechsler, CBER is heralding its rich regulatory history while preparing to tackle new scientific and administrative challenges.

Columns and Departments

July 15, 2002

Some good news, some bad news for biotechnology patent holders

by Karl Bayer, Monika Cserjan-Puschmann, Reingard Grabherr, Gerald Striedner, and Franz Clementschitsch, Institute of Applied Microbiology, Vienna, Austria A new strategy for controlling recombinant gene expression improves efficiency, maximizes host vector exploitation, reduces costs, improves product consistency, and accelerates product development. Continuous feeds of limited amounts of inducer proportional to biomass growth grant optimal control over the ratio between gene expression and host cell metabolism, providing stable, prolonged recombinant protein production.

by Gail Sofer, BioReliance Viruses present dangers (and therefore challenges) to biopharmaceutical manufacturing processes. The virus inactivation method chosen depends on the virus and its surrounding medium. This survey article, organized by sample type, lists viral inactivation methods published during the past decade. Part 1 presents data for skin and bone and for cells that are not platelets or blood cells.