BioPharm International-05-01-2002

BioPharm International

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May 15, 2002

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Vaccine conference, manufacturing shortages

Analytical Advances: Strategies in Clarifying Mammalian Cultures

May 15, 2002

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by Charles Lambalot, Millipore Corporation

Analytical Advances: Using Image Informatics - Focusing Proteomics

May 15, 2002

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by Suzanne Mattingly, Scimagix, Inc.

The Not-So-Sure Thing

May 15, 2002

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by Benjamin H. Rudolph, Aptgen, Inc. What's an investor to do when previously rock-solid investments suddenly aren't?

Washington Report: Vaccine Shortages put Spotlight on Production

May 15, 2002

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by Jill Wechsler Bioterrorism and common infections create challenges for manufacturers.

Outsourcing Outlook: E-Procurement ? Successfully Using and Managing Reverse Auctions

May 15, 2002

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by Jim Miller, and Edward P. Miller, PharmSource Informaton Services, Inc. Today, reverse auctions are perceived more realistically than in years past, but they still offer many benefits for both buyer and seller.

Guest Editorial: Validation Bingo

May 15, 2002

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by John E. McEntire Is your company gambling with analytical mehods and with your product's future? Play validation bingo and find out.

Travel Notes: Yes, Virginia, There is Biotech in the Commonwealth

May 15, 2002

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by Lorna D. McLeod, BioPharm A network of resources and infrastructure facilitates the high-tech business actively courted and encouraged by the Commonwealth of Virginia.

Development of an In Situ Spectroscopic Method for Cleaning Validation using Mid-IR Fiber-Optics

May 15, 2002

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by Narinder K. Mehta, Javier Goenaga-Polo, Samuel P. Hernandez-Rivera, David Hernandez, Peter J. Melling, and Mary A. Thomson, Remspec Corporation A fiber-optic, mid-IR spectroscopy probe combined with a grazing-angle reflectance sampling head can be used as a solvent-free in situ method for validating cleanliness with substantial improvement in accuracy.

Validation of Large-Scale Chromatographic Processes, Part 1: Case Study of Neuleze Capture on Macroprep High-S

May 15, 2002

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by Timothy N. Breece, and Charles Schmelzer, Genentech, Inc. FDA requires chromatography procedures to be validated for reuse, cleanability, sanitization, robustness, and (potentially) for virus removal. This case study follows the development of a validation process that combines reuse and characterization studies, defines acceptable running parameters, reduces costs, and meets GMP requirements.

Freezing Bulk-Scale Biopharmaceuticals Using Common Techniques ? and the Magnitude of Freeze-Concentration

May 15, 2002

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by Serena Donnelly Webb, David F. Sesin, Aimee C. Kincaid, Jonathan N. Webb, and Timothy G. Hughes, Integrated Biosystems, Inc. Large-scale freezing and thawing is commonly used in biopharmaceutical manufacturing but is not well understood. Freeze-thaw variations can exist within or between batches, and nonuniform processes raise serious validation concerns.

Analytical Advances: Chemical Management - A Practical Guide

April 15, 2002

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by Mark Wysong, Dolphin Software