Process mapping in API development


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

Matthew Schiesher, PhD

Research Fellow-CD, Cambrex

Matthew currently holds the position of Research Fellow and Chemical Hygiene Officer at Cambrex Charles City, having advanced through various roles within the Chemical Development department since joining the organization in 2005.
During that time, his project focus has transitioned from early phase to full scale commercial manufacturing. Prior to joining Cambrex, Matthew started his professional career at Albany Molecular Research after receiving a PhD from the University of Michigan in 2002.