|
Description
The fundamental principles involved in the engineering of cellular systems
for large-scale production of active proteins and stem cells are presented
to familiarize engineers and life scientists with factors activating and
limiting their bioreactor systems.
Participants
will become familiar with the characteristics of proteins, cellular metabolism
and physiology as they impact bioreactor process development, design and
operation. Critical comparisons among mammalian and other culture systems
for protein production are made. Insights into the latest cell engineering
developments are included.
The seminar extensively discusses bioreactor development, selection and
design, monitoring and control, and large-scale operational issues. Relationship
between large scale bioreactor cell culture and other aspects of production,
facility and regulatory compliance are discussed.
What
you will learn:
- Significance
of cell culture in production of biopharmaceuticals.
- Strategies
and methods for cell line creation and optimization for biologics production.
- Bioreactor
design considerations for the optimum production of biopharmaceuticals.
- Tech transfer,
process design, and process fit and facility modification for large-scale
cell culture expression systems.
- Bioreactor
cell culture as it relates to other aspects of producing a biopharmaceutical;
media development, purification, final formulation, facility design,
clinical development, and regulatory compliance
Who
Should Attend
Personnel in Development, Manufacturing, Engineering, and Validation involved
in process development, tech transfer, validation and operations management
of cell culture systems will benefit from this seminar. A selection of
state-of-the art content mixed with basic principles ensures that attendees
of all experience levels will benefit.
EXPERT
PANEL:
- DIRECTOR:
Frank
Abbato, Principal Engineer, DME Alliance, Inc.
- Benjamin
Beneski, Sr. Manager, Manufacturing, Amgen, Inc.
- Luis
Branco, Chief Scientific Officer, Biofactura, Inc.
- Arnold
H. Horwitz,
Senior Director, Cell Biology, XOMA (US) LLC
- Joseph
Kauten, LSBO Fermentation Lead, Lonza Biologics, Inc.
- Paul
Kubera, Vice President, Technology, ABEC, Inc.
- David
M. Marks, President, DME Alliance, Inc.
- Scott
Richmond, Senior Scientist, Human Genome Sciences,
Inc.
AGENDA
|
Monday,
10 November |
| 8:00-8:15
am |
Opening
Remarks: Introduction & Overview
- Frank Abbato, Principal
Engineer, DME Alliance, Inc. |
|
8:15-10:00
am |
Expression
of Biopharmaceuticals in Mammalian Cells – Vectors and Host
Cells
This session will provide a review of host cells and expression
vector systems for the production of biopharmaceuticals using mammalian
cells. General approaches will be discussed for improving cell line
productivity and production economy using the latest molecular biology
and cell culture techniques.
- Arnold
H. Horwitz, Senior Director, Cell Biology, XOMA (US) LLC
|
| 10:00-10:30
am |
Coffee
Break |
| 10:30-Noon |
Creating a Novel Expression System in NS0
This session will present a roadmap for original engineering
of novel expression systems using the creation of a cholesterol-based
expression system in NS0 as a framework.
- Luis
Branco, Chief Scientific Officer, Biofactura, Inc. |
|
Noon-1:00 pm |
Lunch |
|
1:00-2:00
pm |
Improving
Expression of Biopharmaceuticals in Mammalian Cells – Industrial
Examples, part 1
This session will discuss 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 will be presented.
- Arnold
H. Horwitz, Senior Director, Cell Biology, XOMA (US) LLC |
2:00-3:00
pm |
Improving
Expression of Biopharmaceuticals in Mammalian Cells – Industrial
Examples, part 2
- Arnold H. Horwitz, Senior
Director, Cell Biology, XOMA (US) LLC |
| 3:00-3:30
pm |
BREAK;
coffee/refreshments |
| 3:30-5:00
pm |
Expression
of Biopharmaceuticals in Microbial Cells
This session will discuss 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 will be presented.
- Arnold H. Horwitz, Senior
Director, Cell Biology, XOMA (US) LLC |
|
Tuesday,
11 November |
|
8:00-10:00
am |
Metabolic
Engineering of Cell Culture Medias
This session will present an overview of strategies and methods
for engineering original cell culture medias.
-
Luis Branco, Chief Scientific Officer, Biofactura, Inc.
|
|
10:00-10:30
am |
Coffee
Break |
|
10:30-Noon |
Developing for Scalability
This session will discuss how to adequately explore the process
development design space to ensure future scalability. The implementation
of new technologies to model and analyze cell culture operations before
and during scale-up will also be discussed.
- Benjamin
Beneski, Sr. Manager, Manufacturing, Amgen, Inc. |
|
Noon-1:00 pm |
Lunch |
|
1:00-3:00
pm |
Pitfalls
in Large Scale Bioreactor Design
This session will present an examination of process and equipment
problems and solutions encountered in large scale cell culture operations.
- Benjamin
Beneski, Sr. Manager, Manufacturing, Amgen, Inc. |
| 3:00-3:30
pm |
BREAK;
coffee/refreshments |
|
3:30-5:00
pm |
Building
a Tech Transfer Process
This presentation will focus on strategies for efficient
technology transfer from process development to manufacturing. It
will address hurdles faced when designing a new facility or contracting
manufacturing into an existing facility.
- Frank
Abbato, Principal Engineer, DME Alliance, Inc. |
| 5:00-6:00
pm |
Keynote |
| 6:00-7:00
pm |
Cocktail
Reception (with Exhibitors) |
|
Wednesday,
12 November
|
|
8:00-10:00
am
|
Optimizing
a Process within Existing Bioreactors
This session will discuss methods for process optimization
when restricted by existing facilities and processes. Large scale
industrial examples will be discussed and a novel design for fed-batch
operation suitable for today’s higher-yielding cell lines.
- Scott
Richmond, Senior Scientist, Human Genome Sciences, Inc. |
|
10:00-10:30
am
|
Coffee
Break |
|
10:30-Noon
|
Mammalian
Cell Culture in the Production Scale Bioreactor
This presentation will focus on the operation of large-scale 20,000
liter mammalian cell bioreactors in an FDA-regulated environment.
Discussion will include extrapolation of pilot scale bioreactor production
information to large scale cell culture production and purification
in a GMP production environment.
-
Joseph Kauten, LSBO Fermentation Lead, Lonza Biologics, Inc. |
|
Noon-1:00
pm
|
Lunch |
|
1:00-3:00
pm
|
Biopharmaceutical Product Development Workshop
Participants will tackle a development problem for an example protein
product.
- Multiple Instructors (Moderator-
Frank Abbato) |
|
3:00-3:30
pm
|
BREAK;
coffee/refreshments |
|
3:30-5:00
pm
|
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.
- David Marks, President, DME Alliance,
Inc. |
|
Thursday,
13 November |
|
8:00-10:00
am |
Process
Validation and Re-Validation
This session will provide a cell-culture oriented discussion
of process validation methods, approaches for re-validation and process
amendments, and integration of Quality by Design into the process
validation approach.
-
Frank Abbato, Principal
Engineer, DME Alliance, Inc. |
| 10:00-10:30
am |
Coffee
Break |
|
10:30-Noon
|
Applied
Agitator Design for Bioreactors
This session will present 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.
- Paul Kubera, Vice President Engineering,
ABEC, Inc. |
|
Noon-1:00 pm |
Lunch |
|
1:00-3:00
pm |
Feeding
Strategies, pH Control, and DO Control in Large Scale Bioreactors
This session will lead an interactive discussion of fed-batch development,
operation, and best practices, including a discussion of pH and DO
control centered around large scale operation and transfer of tuning
parameters from small scale to large scale or from facility to facility.
-
Scott Richmond,
Senior Scientist, Human Genome Sciences, Inc. |
| 3:00-3:30
pm |
BREAK;
coffee/refreshments |
|
3:30-5:00
pm |
Wrap-up
and Q&A Panel Discussion |
|
Friday,
14 November |
|
9:00
- 11:00 am: Plant Tour of Amgen-Juncos (Seats are limited.
Advance sign-up required.) |
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. |
