GE Healthcare Life Sciences Introduction to Design of Experiments (DOE1) Introduction Prerequisites Design of Experiments (DoE) has become a necessity for optimization of process development in the biomanufacturing industry. DoE maximizes the information obtained from performed experiments, including the detection of interactions between parameters. It is also a tool for process characterization wherein you identify your design and operating space according to Quality by Design (QbD) guidelines. A basic understanding of chromatography techniques and UNICORNTM 6 is required for the course. Screening Optimization Robustness PreDictor™ Plates Assist Software ÄKTA avant 25 UNICORN 6.0 ÄKTA avant 150 UNICORN 6.1 Course outline This three day training course aims to give an overview of DoE in process development and its application using the ÄKTATM avant system. First, participants will be introduced to DoE and the statistical terms associated with it, followed by a discussion on different DoE designs and the process of evaluating results. The course also includes hands-on exercises evaluating various pre-generated DoE data files. In the wet lab, the attendees will set up and run their own DoE experiments on an ÄKTA avant, assess potential responses and evaluate their results. The conjunction of wet lab experiment and evaluation exercises will provide participants beneficial hands-on experience with DoE. Who should attend This training will be useful for research and development scientists. Learning objectives After attending this course you will: • Understand the concept of DoE, how it relates to QbD and how DoE plays and important role in establishing a process Design Space • Know how to choose a suitable experimental design according to different applications and scenarios • Learn how to evaluate data from DoE investigations and how DoE results can be employed to define Design and Operating Spaces • Gain systems and application knowledge related to DoE www.gelifesciences.com/fasttrak Agenda Day 2 Day 1 Quality by Design : Overview and relevance of DoE DoE Theory - Evaluation of results from DoE investigations Introduction to statistics Class Exercise DoE Theory - Key concepts DoE wet lab - Optimization DoE Theory - Various experimental designs and their properties Case study Day 3 QbD application example DoE wet lab discussion Class Exercise Summary and discussion UNICORN 6 introduction DoE wet lab - Screening GE Healthcare Bio-Sciences AB, Björkgatan 30, 751 84 Uppsala, Sweden. GE, imagination at work, GE monogram are trademarks of General Electric Company. imagination at work ÄKTA , UNICORN, and PreDictor are trademarks of GE Healthcare Companies. © 2014 General Electric Company – All rights reserved. First published June 2012. 29-0230-93 AB