|
Description
Bioreactors and fermenters lie at the heart of systems used to produce
both large and small-molecule therapeutics. These reactors must produce
an environment that is conducive to and optimizes the growth and productivity
of microorganisms ranging from fragile cells to robust bacteria.
This
seminar will provide a detailed review of the factors that contribute
to successful design and operation of cGMP reactors. Bioprocess, unit
operation, hardware design, and process automation fundamentals will be
presented individually and then brought together in case study and workshop
format, illustrating key concepts.
What you will Learn
- How to
define bioprocess requirements
- Inter-relationships
between vessel geometry and agitator mass transfer, heat transfer and
blending capability
- Vessel
and hardware design features and their impact on aseptic performance
- Instrument
and automation approaches for control and GMP compliance
- Integration
of CIP/SIP into the reactor process
Who
Should Attend
Engineers, scientists, and production personnel involved in the design
of bioreactors and fermenters, including component and system suppliers,
end-users, and engineering design firms. Operations personnel can gain
an improved understanding of reactor and ancillary equipment capability
and operating strategies.
EXPERT
PANEL:
- DIRECTOR:
Paul
Kubera, Vice President, Technology, ABEC, Inc.
- Dr.
Wayne Herber, Assistant Vice President, Vaccine Development, Wyeth
Vaccines
- Mark
Herr, Sales Manager, Stainless
Technology
- Barbara
Henon, Manager, Technical Publications, Arc Machines, Inc.
- Jeffrey
Hamilton, Manager, Automation, ABEC, Inc.
- Alan
Powell, Principal Engineer, Process Engineering, Merck
& Co., Inc.
- John
Vitti,
Product Sales Manager - Americas, Saunders HC4 – Crane ChemPharma
- Thomas
Warf, Product/Process Analyst, U.S. Dept. of Health & Human
Services
AGENDA
|
Tuesday,
11 November |
|
8:00-8:15
am |
Opening
Remarks - Overview and Introduction
- Paul Kubera, Vice President,
Technology, ABEC, Inc. |
| 8:15-9:30
am |
Cell
Culture & Fermentation
An overview of cell culture and fermentation operations
will be presented. The relationships between oxygen uptake requirements,
agitator power, heat transfer and aeration are explored and linked
to discrete design and operating parameters.
-
Dr. Wayne Herber,
Assistant Vice President, Vaccine Development, Wyeth
Vaccines
|
| 9:30-10:00
am |
Vessel Design for Bioprocessing
This session will discuss the design
of vessels and heat transfer surface for GMP applications, material
of construction options, features and benefits.
- Mark
Herr, Sales Manager,
Stainless Technology |
| 10:00-10:30
am |
Coffee
Break |
| 10:30-Noon |
cont’d. - Vessel Design for Bioprocessing |
|
Noon-1:00 pm |
Lunch |
|
1:00-2:30
pm |
Agitator
Selection
This session will discuss mixing and mass transfer fundamentals
as they apply to bioprocessing, followed by a discussion on agitator
selection & scale-up guidelines to maximize performance while
managing shear effects.
- Paul
Kubera, Vice President, Technology,
ABEC, Inc.
|
|
|
Reactor
Design Workshop
Team-based case study for selection of
vessel, agitation system, heat transfer system and related hardware.
- Paul
Kubera, Vice President, Technology,
ABEC, Inc.
|
| 3:00-3:30
pm |
BREAK;
coffee/refreshments |
| 3:30-5:00
pm |
cont’d.
- Reactor Design Workshop |
| 5:00-6:00
pm |
Keynote |
| 6:00-7:00
pm |
Cocktail
Reception (with Exhibitors) |
|
Wednesday,
12 November |
| 8:00-9:00
am |
Orbital
Welding
A practical discussion on weld configuration and impact of
material constituents, including a demonstration of proper orbital
welding techniques and procedures.
- Barbara
Henon, Manager, Technical Publications, Arc Machines, Inc. |
| 9:00-10:00
am |
Agitator
Mechanical Seals and Magnetic Couplings
Mechanical seal selection, features and benefits for top and bottom-mounted
agitators in aseptic service will be presented and discussed, including
magnetic coupling options.
-
Paul Kubera,
Vice President, Technology,
ABEC, Inc.
|
| 10:00-10:30
am |
Coffee
Break |
|
10:30-Noon |
Drain, Sample & Isolation Valves
This session will provide a review of valve types, features, and applications
practice for aseptic service.
- John
Vitti, Product Sales Manager - Americas, Saunders HC4 – Crane
ChemPharma |
| Noon-1:00
pm |
Lunch |
| 1:00-2:00
pm |
Bioreactor Instrumentation & Control Loops
An overview of basic instrumentation needs will be presented including
common approaches to temperature, pH, DO and dissolved CO2 control.
- Jeffrey Hamilton, Manager,
Automation, ABEC, Inc. |
|
2:00-3:00 pm |
System
Design Guidelines
This session will discuss bioreactor system design approaches for
cleanliness, mechanical, ergonomic and architectural constraints.
-
Paul Kubera,
Vice President, Technology,
ABEC, Inc.
|
| 3:00-3:30
pm |
BREAK;
coffee/refreshments |
| 3:30-5:00
pm |
Controls
& GMP Compliance
This session will review SCADA, DCS, PLC & analog control systems
including a discussion of 21 CFR Part 11 and validation considerations.
- Thomas Warf, Product/Process Analyst,
U.S. Dept. of Health & Human Services |
| 5:00-6:00
pm |
Feature
Presentation |
|
Thursday,
13 November |
|
8:00-9:30
am |
Engineering
for Clean-In-Place
This session will examine various cleaning mechanisms and the effect
of velocity and chemical composition of the cleaning agents.
- Alan
Powell, Principal Engineer, Process Engineering, Merck & Co.,
Inc. |
|
9:30-10:00
am |
Engineering for Sterilization
Review of the challenges and design parameters for successful steam
sterilization will be discussed as well as information related to
design configuration and kill correlations.
- Thomas Warf, Product/Process Analyst,
U.S. Dept. of Health & Human Services |
| 10:00-10:30
am |
Coffee
Break |
| 10:30-11:30
am |
cont’d. - Engineering for Sterilization |
| 11:30-Noon |
Reactor
Design “Rules of Thumb”
This session will discuss commonly applied guidelines that can be
used to quickly estimate bioreactor system design parameters and hardware.
- Thomas Warf, Product/Process Analyst,
U.S. Dept. of Health & Human Services |
|
Noon-1:00 pm |
Lunch |
| 1:00-3:00
pm |
Workshop:
Integrated Design of CIP/SIP for Bioreactors & Fermenters
Team-based design of a CIP/SIP system for a fermentation case study.
- Alan
Powell, Principal Engineer, Process Engineering, Merck & Co.,
Inc.
-
Thomas Warf, Product/Process Analyst, U.S. Dept. of Health & Human
Services |
| 3:00-3:30
pm |
BREAK;
coffee/refreshments |
| 3:30-5:00
pm |
cont’d.
- Workshop: Integrated Design of CIP/SIP for Bioreactors &
Fermenters |
|
Friday,
14 November |
|
9:00
am - 11:00 am: Plant Tour of AMGEN-Juncos (Seats are limited.
Advance sign-up is 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. |
