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:

  • How to understand and prevent pitfalls that could impact your early-stage program
  • Key components necessary for proper CMC data within an IND submission
  • How to find the right CDMO to prepare your molecule for IND and beyond.