Pharmaceutical Technology-10-01-2010

The authors describe the operational requirements and design of a process-ready PAT-based IBD system.

The author discusses new detection-system technologies that can improve performance and provides key criteria to consider when selecting or upgrading a system for pharmaceutical use.

Several industry experts describe applications in pharmaceutical applications, including on-line total organic carbon analysis, ultra-fast liquid chromatography, rapid microbial testing, and differential scanning calorimetry-Raman Spectroscopy.

The author outlines key considerations for carrying out a structured approach to monitoring process performance and ensuring product quality.

The author describes the development of small-angle X-ray scattering and analyzes its advantages in the characterization of drug-delivery systems and large molecules. This article is part of a special Analytical Technology issue.

The authors discuss the approach taken to develop a new calibration approach, its associated protocols, and how it can be used to calculate data.

The authors review and discuss the influence of glycans on the conformation of a representative IgG1 biopharmceutical using H/DX-MS as an analytical tool.