Time and sensitivity are essential for analytical technologies in all phases of biopharma development.

DS InPharmatics Head of Analytical Services, Colman Byrne joins the show to share his experience in analytical method development and validation.

The authors describe the development and implementation of covalidation strategies to accelerate analytical method transfer using examples from a pilot study.

Analytical Method Development in Liquid Chromatography Publication Trend The graph below shows the total number of publications each year in Analytical Method Development in Liquid Chromatography.

Analytical method development, part 1 Theory and factors affecting resolution – a reminder of the importance of resolution, separation factor (selectivity), retention factor (capacity factor) and ...

Its services include comprehensive analytical method development and validation processes that follow the highest standards and meet all CGMP requirements and ICH guidelines.

Similarly, method robustness requires continuous assessment during method development (not just during the analytical team’s learning curve).

Analytical services normally included in the pharmaceutical offering comprise: development and validation of stability indicating analytical methods, supply and execution of method transfer ...

In the information age, bridging the gap between data and clinical application is crucial. The Center for Clinical and Translational Science (CCTS) is making significant investments in this area. Over ...

Analytical method development, part 1 Theory and factors affecting resolution - a reminder of the importance of resolution, separation factor (selectivity), retention factor (capacity factor) and ...