| Description
This seminar is designed to provide the participant with a basic understanding
of key issues in designing and implementing a purification process for
the production of a biopharmaceutical material. Scale-up of chromatographic
and filtration operations will be discussed in detail with attention to
validation issues. Process scenarios for recombinant proteins and antibodies
will be used to further the basic concepts.
What You Will Learn
- Understand
and apply basic scale parameters in chromatography and filtration.
- Understand
the basics of various production strategies and how they impact process
design.
- Process
requirements and analytical techniques used to judge quality in manufacturing.
Who
Should Attend
This seminar is intended for professionals involved in the design, scale-up,
and operation of bioprocess systems. Materials presented will be of benefit
to process, project, and manufacturing engineers and scientists entering
the field or requiring further background in specific separation technologies.
Expert
Panel:
- Seminar
Director: Alan Williams, Manager, Large Scale Applications,
GE Healthcare
- Daniel Bauer, Technical Representative, JW Rew
- Tim
Breece, Senior Manufacturing Scientist, Genentech
- Philip
Nelson, Scientist, Amgen
AGENDA
|
Monday,
June 14 |
| 8:00-8:15
am |
Opening
Remarks - Introduction and Overview
- Alan Williams, Manager, Large
Scale Applications, GE Healthcare |
| 8:15-10:00
am |
Basic Concepts in Chromatography
A discussion of chromatographic techniques nomenclature and metrics
used in process development
- Alan
Williams, Manager, Large Scale Applications, GE Healthcare |
| 10:00-10:30
am |
Coffee
Break |
| 10:30-Noon |
Critical Aspects of Chromatographic Process Design
A discussion of how to design a scalable and robust multi-step
purification strategy.
- Alan
Williams, Manager, Large Scale Applications, GE Healthcare |
|
Noon-1:00 pm |
Lunch |
| 1:00-3:00
pm |
Process
Design I: Filtration for Downstream Process
A review of the critical aspects of membrane system process design
and integration with chromatography processes.
- Dan, Bauer, Technical Representative,
JW Rew |
| 3:00-3:30
pm |
Coffee
Break |
| 3:30-5:00
pm |
cont’d.
- Process Design I: Filtration for Downstream Process |
|
Tuesday,
June 15 |
| 8:00-10:00
am |
Process
Design II: Chromatography Optimization and Scale-up
Optimizing and maintaining the process.
- Dr.Tim Breece, Senior
Manufacturing Scientist, Genentech |
| 10:00-10:30
am |
Coffee
Break |
| 10:30-Noon |
cont’d.
- Process Design II:
Chromatography Optimization and Scale-up |
| Noon-1:00
pm |
Lunch |
| 1:00-3:00
pm |
Production Scenario II: Antibody production process
A look at a mammalian cell process making antibody at the 100-g level.
-
Phil Nelson, Scientist, Amgen |
| 3:00-3:30
pm |
Coffee
Break |
| 3:30-5:00
pm |
cont’d.
- Production Scenario II: Antibody production process |
| 5:00-7:00
pm |
Keynote
and Cocktail Reception (with Exhibitors) |
|
Wednesday,
June 16 |
| 8:00-12:00
am |
Application
of ASME Bioprocessing Equipment (BPE) Standard
Separate registration required.
Click
here for more details |
| 1:00-5:00
pm |
ASME BPE Committee Meetings (June 16-18). Open to
the public. No registration required. |
REGISTER NOW!
Visit www.asmeconferences.org/Bioprocess10
ASME
Travel Policy : ASME
is not responsible for the purchase of non-refundable airline tickets
or the cancellation/change fees associated with canceling a flight. Please
call to confirm that the course is running before purchasing airline tickets.
ASME retains the right to cancel a course up until 3 weeks of the scheduled
presentation date. |