|
Sunday,
October 22, 2006
|
| 5:00
pm - 8:30 pm |
Course Registration |
|
Monday, October 23, 2006
|
| 7:30
am - 8:30 am |
Registration Desk Open / Continental Breakfast |
|
8:30
am - 10:00 am
|
Biopharmaceuticals
Derived from Bioreactor Processes
A
Review of biotechnology products derived from bioreactor processes.
Manufacturing, regulatory and healthcare impact. General overview.
|
|
|
10:00
am - 10:30 am
|
Refreshment
Break |
|
10:30
am - 12:00 noon
|
Expression
of Biopharmaceuticals in Mammalian Cells - Vectors and Host Cells
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. |
|
|
12:00
noon - 1:00 pm
|
Lunch |
|
1:00
pm - 2:30 pm
|
Improving
Expression of Biopharmaceuticals in Mammalian Cells - Industrial
Examples
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.
|
|
|
2:30
pm - 3:00 pm
|
Refreshment
Break |
|
3:00
pm - 4:30 pm
|
Laboratory
Scale Cell Culture Biotechnology
Laboratory and pilot scale bioreactors for
the production of biopharmaceuticals. Process design and optimization.
How to link between laboratory scale cell culture and manufacturing
in large 5-10,000 liter bioreactors. T-Flasks, spinner flasks,
small bioreactors, hollow fiber bioreactors, media development
and optimization. |
|
| 4:30
pm - 5:30 pm |
KEYNOTE
Presentation |
| 5:30
pm - 7:00 pm |
Opening
Reception w/ Exhibitors |
|
Tuesday,
October 24, 2006
|
| 7:30
am - 8:30 am |
Registration Desk Open / Continental Breakfast w/ Exhibitors |
| 8:30
am - 10:00 am |
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
Process Scientist
Lonza Biologics Inc.
|
|
10:00
am - 10:30 am
|
Refreshment
Break w/ Exhibitors |
| 10:30
am - 12:00 noon |
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
Process Scientist
Lonza Biologics Inc.
|
|
12:00
noon - 1:00 pm
|
Lunch
w/ Exhibitors |
|
1:00
pm - 2:30 pm
|
Production
Scale Bioreactor Design and Construction |
Paul
Kubera
Vice President, Engineering
Associated Bio Engineers & Consultants
|
|
2:30
pm - 3:00 pm
|
Refreshment
Break w/ Exhibitors |
|
3:00
pm - 4:30 pm
|
Bioreactor
Equipment, Process and Cleaning Validation
Validation of Bioreactors with respect to Equipment,
Process and Cleaning will be discussed in detail. IQ (Installation
Qualification) and OQ (Operational Qualification) of Bioreactors.
Definition of Critical and Non-Critical Production Process Parameters
and the use of DOE (Design Of Experiments) to define Parameter
Ranges. COP, CIP of Bioreactors. Rinse, Swab and Visual methods
for the Validation of Bioreactors.
|
|
|
Wednesday,
October, 25, 2006
|
| 7:30
am - 8:30 am |
Registration Desk Open / Continental Breakfast w/ Exhibitors |
|
8:30
am -10:00 am
|
A
Primer in Lyophilization
The principal topic is one of physical chemistry,
but aseptic processing and suitable engineering will be ever present.
This presentation is suitable for persons who have previously
been introduced to lyophilization. Information to be presented
is essential to those who might participate in cycle development
or product failure investigation. |
|
|
10:00
am - 10:30 am
|
Refreshment Break w/ Exhibitors |
|
10:30
am - 12:00 noon
|
A
Primer in Lyophilization
The course content will focus on the big three
— freezing, primary drying, and secondary drying — and
will not ignore the importance of surrounding confounding variables
such as chemical formula, equipment mechanical competence, sterilization,
stoppering, components, moisture testing, and a myriad of other
issues which influence final product quality. As time permits,
we will end with the algebraic relationship between ice interface
temperature, chamber pressure and shelf temperature. |
|
|
12:00
noon - 1:00 pm
|
Lunch
w/ Exhibitors |
|
1:00
pm - 2:30 pm
|
Bioreactor
Engineering - Mass Transfer, Heat Transfer and Agitation Design
This presentation will explore the principles and
practice of bioreactor scale-up for fermentation and cell culture.
We will review the fundamentals of stirred-tank bioreactor design,
with a special emphasis on processing issues at large scale. Class
discussion and exercises will focus on the scale-up issues associated
with mass transfer, heat transfer and agitation. |
|
|
2:30
pm - 3:00 pm
|
Refreshment
Break w/ Exhibitors |
|
3:00
pm - 4:30 pm
|
Bioreactor
Engineering - Equipment Design, Instrumentation and Control
Design
Bioreactor
design requires the rigorous application of aseptic design principles,
addressing unique SIP, CIP and containment issues. This presentation
will focus on the equipment and control design requirements
for reliable bioreactor operation, including strategies for
integrating cell culture and fermentation systems into biologic
manufacturing operations. Concluding this presentation, there
will be a discussion on the industry trends in cGMP bioreactor
design & regulatory requirements.
|
|
|
Thursday,
October 26, 2006
|
| 7:30
am - 8:30 am |
Registration Desk Open / Continental Breakfast |
|
8:30
am - 10:00 am
|
Identification
of Critical Process Parameters
This presentation
will provide an overview for the identification of critical process
parameters during the manufacture of biopharmaceutics. The presentation
will provide an insight into the validation requirements and their
subsequent use in process comparability. Attendees will be given
an opportunity to discuss their examples. |
Ash
Ramzan
Principal Consultant
Woodley BioReg Limited
|
|
10:00
am - 10:30 am
|
Refreshment
Break |
|
10:30
am - 12:00 noon
|
Demonstration
of Comparability of Biological Products during Process Development
This presentation will build on the learnings from
the identification and control of critical process steps and will
use these to demonstrate process comparability throughout development
and commercialization. The presentation will provide an insight
into the growing area of Biosimilars and illustrate the strengths
and weaknesses of Comparability Protocols in the US and EU. |
Ash
Ramzan
Principal Consultant
Woodley BioReg Limited
|
|
12:00
noon - 1:00 pm
|
Lunch |
| 1:00
pm - 2:30 pm |
Regulatory
Aspects of Biopharmaceutical Product Development
Overview and pragmatic solutions during biopharmaceutical
product development. Regulatory aspects of "Generic"
Bio-Similar Biopharmaceuticals. |
All
Instructors
|
| 2:30
pm - 3:00 pm |
Refreshment
Break |
| 3:00
pm - 4:00 pm |
Biopharmaceutical
Product Development Workshop
Seminar participants will outline the tasks and
timelines for the development of a complex biopharmaceutical composed
of a binary protein attached to a chelator delivering a cytotoxic
radioactive element for targeted therapy. |
All
Instructors
|
|
4:00
pm - 5:30 pm
|
PLANT TOUR: BRI Bioprocess
Plant - 50 Maximum |
|
Friday,
October 27, 2006
|
|
9:00
am - 10:30 am
|
PLANT TOUR: BRI Bioprocess
Plant - 50 Maximum |
