BioPharm International-05-01-2002

Columns and Departments

May 15, 2002

Vaccine conference, manufacturing shortages

by Charles Lambalot, Millipore Corporation

by Suzanne Mattingly, Scimagix, Inc.

Columns and Departments

May 15, 2002

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

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

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.

Columns and Departments

May 15, 2002

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

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.

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.

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.

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.

by Mark Wysong, Dolphin Software