Process mapping in API development
sponsored by Cambrex
The Cambrex team in Charles City, Iowa was working towards development of a commercial manufacture of a process designed for a small molecule API, and was challenged with quickly establishing operating parameters suitable for regulatory filings.
The team applied multivariate experimental design and analysis in pre-validation process mapping studies as the means to quantify the impact of altering variables and identify robust conditions for manufacturing.
The study defined specification limits, critical process parameters and proven acceptable ranges to support the validation timeline. Join Cambrex expert Matthew Schiesher, PhD, as he walks through a case study detailing an effective strategy for process establishment and optimization.
Webinar Learning Objectives
- Strategy to guide a process from an initial pilot batch to validation
- Applying Design of Experiments to set Critical Process Parameters and Proven Acceptable Ranges
- Recognizing opportunities for future optimization