Biopharmaceutical Analysis

by Suzanne Mattingly, Scimagix, Inc.

by Mary Ellen Goffredo, NuGenesis Technologies Corporation Weighing the Options

by Jane Turton, Central Public Health Laboratory and Zain Moola This case study shows that storing an ion-exchange chromatography gel in dilute alkalai, followed by removal of the solubized material, enhances gel cleaning. More material is removed from the gel during column recycling, and carry over of material from one cycle to the next is substantially reduced.

By Jim Erickson, Blue Mountain Quality Resources, Inc., pp. 63-64. In the fast-paced biopharmaceutical manufacturing environment, "speed to market" is the hallmark catch phrase. Many companies are focusing only on the processes that add the most value and are outsourcing the rest. This focus on core competencies has some biotech companies reevaluating their calibration practices. Many are contracting more of that workload, from both laboratory and production facilities, to calibration service laboratories.