December 4th 2024
A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study.
NGS abbreviates drug discovery timelines.
Storing an Ion-Exchange Chromatography Gel in Dilute Alkali During Recycling Improves Cleaning
April 15th 2002by 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.
Analytical Advances: Calibration Management of Outsourced Calibrations
February 15th 2002By 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.