Add Efficiency From Development To Validation with Experiment Design, Part 1

How To Add Efficiency From Development To Validation With Design Of Experiments, Part 1

Among many challenges in the biopharmaceutical product development cycle is the development and validation of high-yielding, reproducible processes for manufacturing products that are suitable for use in humans. Unless a platform process is available for a “plug-and-play” approach to process development, a broad variety of potential process input parameters must be evaluated against a similarly large set of output parameters. In some cases, even platform processes need to be modified to account for the biochemical differences between similar biological products.

Read the full article to gain insights on statistically-based design-of-experiments (DoE) basics, strategy, and in process validation 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.