White Papers

Integrating Good Manufacturing Practices During the Transition from Clinical Trials to Commerical Manufacturing

Our experience shows that early adoption of GMP (Good Manufacturing Practices) by a company, can lead to a faster, lower-cost ramp-up from clinical trials to full commercial manufacturing, in-house or out-sourced. The interpretation of compliance regulations, and subsequent recommendations in this document, are a compilation of years of experience and best practices from leading bio/pharmaceutical companies.

Increasing Chromatographic Productivity and Reducing Solvent Consumption with ACQUITY UPLC

In today’s economic climate, the need to produce more results with fewer resources, faster is a theme that is heard regularly in the world of analytical chemistry. For off-line QC laboratories, cost containment and efficiency are two keys to success in pharmaceutical or biopharmaceutical manufacturing. The throughput, selectivity, and specificity achieved with Waters UltraPerformance LC (UPLC) Technology provides improved chromatographic results while consuming less solvent than traditional HPLC for more cost-efficient laboratory operations that get you to the critical answer you need, faster.

Current Trends in GMP Warning Letters

A detailed look at FDA's 2008-2009 Warning Letters, courtesy of Hogan & Hartson LLP.

Bioscience Education Study Finds Some States Lagging

First-ever report by Battelle, BIO and Biotechnology Institute finds wide disparities in achievement and uneven program efforts