BioPharm International-11-01-2001

Columns and Departments

November 15, 2001

by G. Steven Burrill at Burrill & Company Despite stimulating and positive news for biotech product approvals and high-value deals this quarter, market performance has been shaped by the terrorist attacks and their aftermath.

by Naidong Weng and Timothy D.J. Halls Covance Laboratories, Inc. LC/MS/MS provides superior sensitivity and selectivity, rapid analysis, maximized development efficiencies, and improved turnaround times. Although large-scale LC/MS/MS analysis is fraught with challenges, you can learn to overcome the obstacles with careful planning and these troubleshooting techniques. Part 1 presents troubleshooting techniques related to sample preparation and chromatography.

Product Development and Analysis

November 15, 2001

by Brian Schlain, Hitendra S. Jethwa, Meena Subramanyam, Kevin Moulder, Bhavna Bhatt, and Michael Molloy Standard 96-well microplate assays are prone to edge and bowl effects. Such plate location effects can badly bias potency estimates. Easy-to-use plate layouts enable scientists to adjust estimates for such effects when analyzing new production drug batches. This article is indebted to the work reported by Russell Reeve (BioPharm, July 2000) and the subsequent letters from David Lansky and Reeve (BioPharm, September 2000).

Product Development and Analysis

November 15, 2001

by Suggy S. Chrai, R. Murari, and Imran Ahmad Liposomal formulations are increasingly being used in biopharmaceutical development projects. Good manufacturing processes must reproducibly fabricate lipid vesicles that are as uniform in size as possible, carry the drug in sufficient concentration, and remain stable for an acceptable shelf-life under varying temperatures.

Product Development and Analysis

November 15, 2001

by Joseph M. Przechocki OriginLab Corporation The mathematics behind quantifying the response of different chemical compounds competing with an agonist for the same biological binding site are well understood, but the process can be repetitive and tedious. Learning full use of new scientific software will give you the time to put your talents to more creative use.

Columns and Departments

November 15, 2001

by William Bierce and Jim Miller Is that great deal too good to be true?

by Steven Ford and William E. Tente Chimeric Therapies, Inc. Experience shows that murine MAbs used in cell therapy manufacturing can be produced with safety concerns in mind. In such cases, adequate characterization ensures that they retain functional integrity.