BioPharm International-01-01-2003

by Gail Sofer, BioReliance With West Nile virus in the news, viral inactivation is under public scrutiny. Yet, the culture media, the therapeutic product, and the potential viral contaminants can all affect the inactivation method chosen during production. Viral inactivation techniques ? those tried or used in manufacturing or in final biopharmaceuticals, vaccines, and media products ? have been gathered from recent scientific literature and organized in this article series as an addition to your process development toolbox.

by Denise Wendt The Court's decision not to allow the patenting of higher life forms puts it at odds with Japan, europe, and the United States.

Focus On Separation and Purification

January 15, 2003

by Tim N. Warner and Sam Nuchumson, Pall Life Sciences If the hidden expenses associated with laboratory purchases ? labor, cleaning, buffers, validation, time delays ? are identified, reduced processing costs, higher throughput, and accelerated time-to-market are possible. This comparison between resin and membrane chromatography helps shed light on some hidden costs.

by Mark Tuomenoska, OpenReach, Inc. and Jim Miller, Bio/Pharmaceutical Outsourcing Report Outsourcing can be a booster rocket in the race to patent and market innovative products.

by Jill Wechsler Manufacturers are concerned about congressional efforts to establish a Medicare pharmacy benefit and to regulate research while FDA shifts regulation of biologics and other drugs.

by S. Alison Arnold, Linda M. Harvey, and Brian McNeil, Strathclyde Fermentation Centre (Scotland), and Jeffrey W. Hall, FOSS NIRSystems Timely process information is required to make effective fermentation decisions, but those data are rarely available. NIR spectroscopy can allow you ? by incorporating rapid, nondestructive, multiconstituent analyses of fermentation broth directly into fermentation control strategies ? to make those decisions. This article will help you make that improvement by outlining the analysis strategies.

Columns and Departments

January 15, 2003

by Joseph Noferi, Pharmacia GS API Biopharma

Focus On Separation and Purification

January 15, 2003

by Leaford Blevins and Tom Gerbo, HDR Facility design can affect the bottom line in biopharmaceutical manufacturing. The authors offer insights about what to look for and what to consider in facility design ? whether you're retrofitting an existing facility or building from the ground up.

Focus On Separation and Purification

January 15, 2003

Anurag Rathore, Pharmacia Corporation and Ajoy Velayudhan Optimizing your purification and separation process when your complex biological feedstock is ready for scale-up can be daunting. Your design process can be streamlined, simplified, and made cost efficient if you supplement your empirical approach with the theoretical and experimental tools presented in this article.

by David Butler, Spotfire Inc.

by Jack Dolmat, Clark/Bardes Consulting Compensation for board members varies widely with company size, but as more is expected, compensation practices are changing too.

Columns and Departments

January 15, 2003

by Kevin Robinson For "me too" manufacturers, the growth opportunity is in Europe ? and in biogenerics.