|
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:
- DIRECTOR:
Alan
Williams, Manager, Large Scale Applications, GE Healthcare
- Daniel
Bauer, Technical Representative, JW Rew
- Dr.Tim
Breece, Senior Manufacturing Scientist, Genentech
- Dr.
Philip Nelson, Scientist, Amgen
AGENDA
|
Monday,
10 November |
| 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 |
| 1:00-2:00
pm |
Process
Design I Membrane Process
A review of the critical aspects of membrane system process design
and integration with chromatography processes.
- Dan, Bauer, Technical Representative,
JW Rew |
2:00-3:00
pm |
cont’d.
- Process Design I Membrane Process |
| 3:00-3:30
pm |
BREAK;
coffee/refreshments |
| 3:30-5:00
pm |
cont’d.
- Process Design I Membrane Process |
|
Tuesday,
11 November |
| 8:00-10:00
am |
Process
Design II
Optimizing and maintaining the process. A continuation of
Process Design I.
- Dr.Tim Breece, Senior
Manufacturing Scientist, Genentech |
| 10:00-10:30
am |
Coffee
Break |
| 10:30-Noon |
cont’d.
- Process Design II |
| 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.
-
Dr. Phil Nelson, Scientist, Amgen |
| 3:00-3:30
pm |
BREAK;
coffee/refreshments |
| 3:30-5:00
pm |
cont’d.
- Production Scenario II: Antibody production process |
5:00-6:00
pm |
Keynote |
| 6:00-7:00
pm |
Cocktail
Reception (with Exhibitors) |
|
Wednesday,
12 November
|
|
8:00-10:00
am
|
Industrial
Scale Column packing
Discussion of column packing techniques, the critical aspects
of good column packing, and its effects on production.
-
Alan
Williams, Manager, Large Scale Applications, GE Healthcare |
|
10:00-10:30
am
|
Coffee
Break |
|
10:30-Noon
|
cont’d. - Industrial Scale Column packing |
|
Noon-1:00 pm
|
Lunch |
|
1:00-3:00
pm
|
Current
Topics in Process Validation
Proven Methods and Strategies in Validation of Biopharmaceutical Manufacturing
-
TBD |
|
3:00-3:30
pm
|
BREAK;
coffee/refreshments |
|
3:30-5:00
pm
|
Wrap-up
and Roundtable Q&A
- Panel: Alan Williams,
Tim Breece, Phil Nelson, Dan Bauer |
REGISTER
NOW! Visit www.asmeconferences.org/Bioprocess08
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. |
