BioPharm International-01-01-2002

by Jim Miller, BioPharmaceutical Outsourcing Report With Internet technologies, CROs can share risks, cut costs, and improve asset performance.

by Jill Wechsler Continued concerns about bioterrorism will shape legislative and regulatory initiatives affecting biotech manufactures.

by Benjamin H. Rudolph and Viqar Aslam, Aptagen, Inc. One company shows the world that stem cell research isn't coing away -- and receives a worldwide ctroversy in the process.

by Robert T. Magari, Beckman Coulter Corporation In laboratory testing, you may want to use a new analytical method for measuring a chemical substance. To do so, you must be able to prove that the new method gives the same results as the previous one. Not all statistical methods for making laboratory comparisons are equally valid.

by S. Anne Montgomery

by Naidong Weng and Timothy D.J. Halls, Covance Laboratories, Inc. Meeting the challenges of large-scale LC/MS/MS can improve the analytical processes that support biopharmaceutical drug development. The conclusion of this article presents troubleshooting techniques for LC/MS/MS and illustrates an automation strategy.

by Suggy S. Chrai, R. Murari, and Imran Ahmad Good manufacturing processes require that lipid vesicles be reproducibly uniform in size, carry the drug in sufficient concentration, and remain stable for an acceptable shelf-life under varying temperatures. Following these guidelines improves the analytical processes that support biopharmaceutical drug development.

by Joseph F. Noferi, Daniel E. Worden, and Edward R. Arling Understanding the reach of 21 CFR Part 11 is the first step to assessing its impact. To protect your company, you need integrated quality audit solutions to evaluate the underlying validation of your electronic data.

by Harish Iyer, Felicia Henderson, Eric Cunningham, James Welbb, John Hanson, Christopher Bork, and Lynn Conley, IDEC Pharmaceuticals Corporation Scale-up changes in an antibody purification process can increase final product purity, make the process more robust, and reduce processing time. This case study focuses on the initial purification step -- protein A chromatography -- and offers data collected from several years of process development work on many different antibodies.