Webinar: When to Apply Design of Experiments (DoE) to ADC Development

Justin Sweeley, Novasep

Live Webinar: When to Apply Design of Experiments (DoE) to ADC Development
Date: September 24, 2019
Time: 8AM PDT / 5PM CEST
Presented by: Novasep – Justin Sweeley, PhD, Senior Technology Manager for Biologics, N.A.

Introduction
DoEs are a specific application of statistical techniques to enable rapid and robust development. Those techniques can be directed towards factor screening or process robustness depending on the specific needs of the project phase. Often these experiments result in a stronger process understanding, while requiring less time and fewer material resources.

Our team at Novasep has spent the last 25 years practicing this technique in complex high potent synthesis reactions with a particular expertise in chromatographic seperations. With our expansion into ADC conjugation space, we have brought our breadth of experience into ADC conjugation development.

ADC Bio
Lonza
MabPlex
 

Description
In this webinar, we will speak about the application of DoE in the ADC development process. We will identify when this tool is effective through different case studies:

  1. Example of a DoE applied to Analytical method development
  2. When DoE is not an applicable tool and what can be implemented in its place
  3. Highlights from a project where a 2-block response surface DoE increased process robustness

Presented By
Justin Sweeley, Ph.D.Justin Sweeley is Novasep’s Senior Technology Manager for Biologics in North America. He has a Bachelor degrees in Molecular Biology, Chemistry, and Biochemistry from the University of Colorado at Boulder and also completed a PhD in Chemical and Biological Engineering from Colorado State University.

Justin joined Novasep in 2018. He has 9 years of experience with process development in the pharmaceutical industry and prior to joining Novasep was a senior scientist working on cGMP technology transfer for ADC projects.

Justin has a wide experience in Antibody Drug Conjugate process and analytical development, and a specific expertise in DoE based process development, and QbD based process validation.