Add Biologics Manufacturing Efficiency with Experiment Design

How To Add Biologics Manufacturing Efficiency With Design Of Experiments, Part 2

In part 1 of this article series we described how a statistically-based design of experiments (DoE) strategy can accelerate biopharmaceutical process development and reduce development costs by streamlining process development experiments. DoE strategies can efficiently screen process parameters for their criticality and identify the proven acceptable ranges for those parameters by application of statistical rigor in a reduced set of experiments. Here in part 2, we will discuss using DoE methodology to similarly streamline process optimization with two case studies. DoE optimization designs may be used to study three or four parameters at multiple levels to find their optima. As an example, three parameters can be evaluated at five levels in a set of 20 experiments.

Read the full article to gain insights on the role of experiments in characterization and validation, executing a DoE study, and more from Peter Alexander, an Alira Health Consultant with over 35 years of industrial biotechnology experience in process development for therapeutic and vaccine products in numerous technology platforms, and Thomas Harrington, a consultant with over 20 years of experience in biopharmaceutical and pharmaceutical process development and manufacturing.