Introduction to Design of Experiments (DOE1)

GE Healthcare
Life Sciences
Introduction to Design of Experiments (DOE1)
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.
PreDictor™ Plates
Assist Software
ÄKTA avant 25
ÄKTA avant 150
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
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
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.
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First published June 2012.
29-0230-93 AB