|
Sunday,
September 30, 2007
|
| 3:00
pm - 7:00 pm |
Registration Open - Avoid the lines on Monday |
|
Monday,
October 1, 2007
|
| 7:30
am - 8:30 am |
Registration Desk Open; Continental Breakfast |
|
8:30
am - 9:15 am
|
The
Role of Process Technology
Placement of process technology in the product life cycle. |
|
|
9:15
am - 10:00 am
|
Expression
of Biopharmaceuticals in Mammalian Cells - Vectors and Host Cells,
part 1
Review of host cells and expression vector systems for the production
of biopharmaceuticals using mammalian cells. General approaches
for improving cell line productivity and production economy using
the latest molecular biology and cell culture techniques. |
|
|
10:00
am - 10:30 am
|
Refreshment
Break |
|
10:30
am - 12:00 noon
|
Expression
of Biopharmaceuticals in Mammalian Cells - Vectors and Host Cells,
part 2,
Improving Expression of Biopharmaceuticals in Mammalian Cells -
Industrial Examples, part 1
Approaches for improving production of biopharmaceuticals using
mammalian cells. Specific examples of improving cell line productivity
and production economy using the latest molecular biology and cell
culture techniques.
|
|
|
12:00
noon - 1:00 pm
|
Lunch |
|
1:00
pm - 1:45 pm
|
Improving
Expression of Biopharmaceuticals in Mammalian Cells - Industrial
Examples, part 2
Approaches for improving production of biopharmaceuticals using
mammalian cells. Specific examples of improving cell line productivity
and production economy using the latest molecular biology and
cell culture techniques.
|
|
|
1:45
pm - 2:30 pm
|
Media
Design for Life Cycle Process Validation
Media Design considerations with case studies for anticipating
future process changes and ease of maintaining process validation.
|
|
|
2:30
pm - 3:00 pm
|
Refreshment
Break |
|
3:00
pm - 5:00 pm
|
Expression
of Biopharmaceuticals in Microbial Cells
Approaches for improving production of biopharmaceuticals using
microbial cells. Specific examples of improving cell line productivity
and production economy using the latest molecular biology and microbial
techniques. |
|
| 5:00
pm - 6:00 pm |
Networking
Hour |
|
Tuesday,
October 2, 2007
|
| 7:30
am - 8:30 am |
Registration Desk Open; Continental Breakfast |
| 8:30
am - 10:00 am |
Developing
for Scalability
How to adequately explore the process development design space
to ensure future scalability. Implementation of new technologies
to model and analyze cell culture operations before and during scale-up
are also discussed.
|
|
| 10:00
am - 11:00 noon |
Discussion
of Feeding Strategies, pH control, and DO control in large scale
bioreactors
Leveraging advances in large scale cell culture methodology to maximize
process development results. |
|
|
11:00
am - 11:15 am
|
Refreshment
Break |
| 11:15
- 12:00 noon |
KEYNOTE |
|
12:00
noon - 1:00 pm
|
Lunch
|
|
1:00
pm - 2:30 pm
|
Mammalian
Cell Culture in the Production Scale Bioreactor
Operation of large-scale 20,000 liter mammalian cell bioreactors
in an FDA-regulated environment. Extrapolation of pilot scale bioreactor
production information to large scale cell culture production and
purification in a GMP production environment. |
Joseph
Kauten
Lonza Biologics
|
|
2:30
pm - 3:00 pm
|
Refreshment
Break |
|
3:00
pm - 5:00 pm
|
Pitfalls
in Large Scale Bioreactor Design
Examination of process and equipment problems and solutions encountered
in large scale cell culture operations.
|
|
| 5:00
pm - 7:00 pm |
Opening
Reception with Exhibitors |
|
Wednesday,
October, 3, 2007
|
| 7:30
am - 8:30 am |
Registration Desk Open; Continental Breakfast w/ Exhibitors |
|
8:30
am -10:00 am
|
Bioreactor
Engineering - Mass Transfer, Heat Transfer and Agitation Design
This presentation will explore the principles and practice of stirred-tank
bioreactor design and scale-up for fermentation and cell culture.
|
|
|
10:00
am - 10:30 am
|
Refreshment Break w/ Exhibitors |
|
10:30
am - 12:00 noon
|
Bioreactor
Engineering - Equipment Design
We will survey best practice for bioreactor equipment design, CIP,
SIP, and lessons learned from implementations in pilot and production-scale
GMP facilities. |
|
|
12:00
noon - 1:00 pm
|
Lunch
w/ Exhibitors |
|
1:00
pm - 3:00 pm
|
Optimizing
a Process within Existing Bioreactors
Methods for process optimization when restricted by existing
facilities and processes.
|
|
|
3:00 pm
|
Refreshment
Break w/ Exhibitors |
|
Thursday,
October 4, 2007
|
| 7:30
am - 8:30 am |
Registration Desk Open; Continental Breakfast w/ Exhibitors |
|
8:30
am - 10:00 am
|
Regulatory
Aspects of Biopharmaceutical Product Development
Overview of pragmatic solutions during biopharmaceutical product
development. Regulatory aspects of "Generic" Bio-Similar
Biopharmaceuticals. |
|
|
10:00
am - 10:30 am
|
Refreshment
Break with Exhibitors |
|
10:30
am - 12:00 noon
|
Applied
Agitator Design for Bioreactors
A practical survey of best practice for agitator design within GMP
bioreactors and the process impact (mixing, shear, reliability,
cleanability, aseptic operation) of agitator design selections.
|
|
|
12:00
noon - 1:00 pm
|
Lunch
w/ Exhibitors |
| 1:00
pm - 2:30 pm |
Biopharmaceutical
Product Development Workshop
Seminar participants will outline the tasks and timelines for
the development of an example protein product, taking into consideration
future scale-up concerns for the products expected market volume.
|
|
| 2:30
pm - 3:00 pm |
Refreshment
Break |
| 3:00
pm - 5:00 pm |
Biopharmaceutical
Product Development Workshop - cont'd.
Seminar participants will outline the tasks and timelines for
the development of an example protein product, taking into consideration
future scale-up concerns for the products expected market volume. |
|
|
5:00
pm - 6:00 pm
|
Networking Hour |
|
Friday,
October 5, 2007
|
|
9:00
am - 10:30 am
|
PLANT TOUR - Genentech Oceanside (Advance Sign-up required) |
