BioPharm International-09-01-2002

by Barbara Tipton, Jeri Ann Boose, Joanne Beck, Thomas O'Brien, and William Larsen, CUNO Incorporated Two types of depth filters are studied for their ability to rid protein solutions of retroviruses and parvoviruses. Such filters are relatively economical and easy to use, so as secondary virus-removing devices, they are beneficial for downstream processing of mammalian cell cultures. Results indicate that depth filters are more effective on retroviruses than parvoviruses.

by Preston Poulter, Poulter Scientific, Inc. Process variations inevitably result in change, and change may mean new regulatory hoops. Statistical quality control is a cost-effective and efficient method for coping with change while still remaining compliant with 21 CFR Part 58.

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by Joseph F. Noferi, Chimeric Therapies, Inc.

by John Curling, ProMetic BioSciences Ltd. Immune serum globulin is in high demand, and that demand will only increase. Yet despite product shortages, the complexities involved in creating new manufacturing processes discourage change. The benefits - increased yield, reduced costs, new technologies, and faster throughput - now make identifying the best place in the processing stream to make manufacturing changes a rewrding endeavor. Planned change always trumps losing market share or being forced to change by new regulations.

by Jill Wechsler. Pressure to enact an affordable Medicare drug benefit is driving legislation that threatens patent protections and boosts cheap imports.

by Jim Miller, Bio/Pharmaceutical Outsourcing Report If a CRO or contract manufacturer was outperforming others in the industry, would anybody notice?

by Gail Sofer, BioReliance Plasma products have been associated with high levels of risk from viral contamination; therefore, most viral inactivation methods described in the literature during the past ten years have addressed plasma and plasma products. Plasma is the largest group to cover, and Part 3 takes two articles in our series to describe the many methods published. This article covers heat and solvent/detergent inactivation treatments for plasma.