GE Healthcare
Life Sciences
Introduction to High-Throughput Process
Development (HTPD1) - Workshop
Introduction
Who should attend?
Time-to-clinic and time-to-market are two key factors for
a successful biopharmaceutical development. Efficient
development of a manufacturing process is a crucial driver
for the success of the overall project plan. High-throughput
tools for process development (HTPD) can help address these
challenges by shortening development time and increasing
the amount of valuable information during process
development stages.
The workshop is aimed at R&D scientists, development
scientists and process engineers who have a working
knowledge of chromatographic techniques but would like to
benefit from a deeper insight into the use of HTPD.
Course outline
This workshop, with practical exercises, focuses on process
development and process optimization of chromatographic
purification steps using HTPD. It shows how PreDictor™ 96well filter plates and PreDictor RoboColumn™, pre-filled with
chromatography media (resins) are used both in manual and
automated mode to define optimal process conditions. In the
laboratory exercises, the use of PreDictor plates for uptake
and elution studies is practiced. Furthermore, the automated
use of PreDictor RoboColumn units will be demonstrated
and discussed. Application examples for the use of HTPD
PreDictor plates are presented including practical hints & tips.
Agenda
Day 2
Day 1
Learning objectives
After attending this workshop, you will:
• know how to plan, design and conduct high throughput
process development experiments
• comprehend key factors to be taken into consideration
when executing HTPD applications
• be trained on suitable techniques to improve separation
performance and increase process productivity and
economy
Total characterization space
Detailed studies to define design space
Area for further optimization
Scale-up
PreDictor prefilled 96-well filter
plates, Assist software, and
PreDictor RoboColumn for
screening of conditions
ÄKTA avant systems,
UNICORN™ 6, HiScreen™, and
HiTrap™ columns for optimization
ReadyToProcess™ platform
and AxiChrom™ columns for
scale-up and production
Day 3
Introduction to HTPD
Batch uptake and adsorption isotherms
Data evaluation: Column verification runs
96-Well plates theory and process design
strategies
Elution studies
Process development workflows
Demo: Automated PreDictor RoboColumn
workflow with a robotic system
Application example - Wash and flowthrough studies
Quality by Design and Design of
Experiments
Application example – CIP
Introduction to Assist
Buffer Preparation with ÄKTA™ avant,
robotic system, and manual preparation
Binding study
Demo: Automated PreDictor plate workflow
with a robotic system
Data evaluation Assist software
HTPD in action: a review of current
applications
DOE column optimization/verification runs
imagination at work
GE Healthcare Bio-Sciences AB, Björkgatan 30, 751 84 Uppsala, Sweden.
GE, imagination at work, GE monogram are trademarks of General
Electric Company.
ÄKTA and PreDictor are trademarks of GE Healthcare Companies.
RoboColumn is a trademark of Atoll GmbH.
© 2011 General Electric Company – All rights reserved.
First published Dec. 2011.
28-9788-64 AC