BioPharm International
September 15, 2002
Separation and Purification
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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.
September 15, 2002
Separation and Purification
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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.
September 15, 2002
Columns and Departments
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by
September 15, 2002
Columns and Departments
15
9
by Joseph F. Noferi, Chimeric Therapies, Inc.
September 15, 2002
Separation and Purification
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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.
September 15, 2002
Columns and Departments
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by Jill Wechsler. Pressure to enact an affordable Medicare drug benefit is driving legislation that threatens patent protections and boosts cheap imports.
September 15, 2002
Columns and Departments
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by Jim Miller, Bio/Pharmaceutical Outsourcing Report If a CRO or contract manufacturer was outperforming others in the industry, would anybody notice?
April 15, 2002
Separation and Purification
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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.