| 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:
- Seminar
Director: Paul
Kubera, Vice President, Technology, ABEC, Inc.
- Ray
Emerson, New England Controls
- Mark
Herr, Sales Manager, Stainless
Technology
- Dr.
William Kelly, Professor, Chemical Engineering, Villanova University
- Alan
Powell, Principal Engineer, Process Engineering, Merck
& Co., Inc.
- John
Vitti,
Product Sales Manager - Americas, Saunders HC4 – Crane ChemPharma
AGENDA
|
Monday,
June 14 |
| 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. Various expression platforms will be reviewed,
along with factors impacting growth and productivity.
-
Dr. William Kelly, Associate Professor, Villanova University, Dept.
of Chemical Engineering |
9:30-10:00
am |
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.
|
| 10:00-10:30
am |
Coffee
Break |
| 10:30-11:30 |
Agitator Selection (cont'd.)
- Paul
Kubera, Vice President, Technology,
ABEC, Inc.
|
11:30-Noon |
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.
|
|
Noon-1:00 pm |
Lunch |
| 1:00-2:00
pm |
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 |
2:00-2:30
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.
|
2:30-3:00
pm |
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 |
Coffee
Break |
|
3:30-5:00
pm |
Reactor
Design Workshop - cont'd.
- Paul
Kubera, Vice President, Technology,
ABEC, Inc.
|
|
Tuesday,
June 15 |
| 8:00-9:00
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. |
| 9:00-10:00
am |
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
|
| 10:00-10:30
am |
Coffee
Break |
| 10:30-Noon |
Bioreactor
Instrumentation & Control Loops
An overview of basic instrumentation needs will be presented including
common approaches to temperature, pH, DO and dissolved CO2 control.
-
Ray
Emerson, New England Controls
|
| Noon-1:00
pm |
Lunch |
| 1:00-2:00
pm |
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.
- Alan
Powell, Principal Engineer, Process Engineering, Merck & Co.,
Inc.
|
|
2:00-3:00 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, Jay Ankers |
| 3:00-3:30
pm |
Coffee
Break |
| 3:30-5:00
pm |
Workshop:
Integrated Design of CIP/SIP for Bioreactors & Fermenters (cont'd.)
- Alan
Powell, Jay Ankers
|
5:00-7:30
pm |
Keynote
and Cocktail Reception with Exhibitors |
|
Wednesday,
June 16 |
| 8:00-12:00
noon |
Application
of ASME Bioprocessing Equipment (BPE) Standard
Separate registration required. Click
here for more details |
| 1:00-5:00
pm |
ASME
BPE Committee Meetings (June 16-18). Open to the public.
No registration required. |
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. |
