|
Description
This seminar will focus on the use of process modeling and simulation
technology to study and improve existing and new manufacturing facilities
in the biotech and pharmaceutical industries. Case studies and lessons
learned from recently completed projects will be presented and discussed
in-depth. Two different types of simulation methods will also be presented.
What
You Will Learn
- What types
of problems are best solved with simulation techniques?
- How can
simulation be used to reduce operating costs or increase throughput?
- What are
some key pitfalls to watch out for on a modeling and simulation project?
- What are
the main benefits of using simulation over conventional engineering
analyses?
Who
Should Attend
This seminar is intended for professionals with direct and/or management
responsibility over biopharmaceutical manufacturing operations. Those
involved with or considering projects to improve plant throughput or reduce
manufacturing costs, including product owners, contract manufacturers
and consulting firms operating in this field. Those considering building
new manufacturing facilities or comparing new facilities to using contract
manufacturing. Typical job functions of those who should consider attending
are: Operations/Manufacturing, Project Management, Engineering Support,
Plant Engineering, Process Development and Facilities Engineering
EXPERT
PANEL:
- DIRECTOR:
Philip
Lyman, Director, Process Simulation, CRB Consulting Engineers,
Inc.
- Demetri
Petrides, Ph.D., President, Intelligen, Inc.
- John
Higgins, Associate Scientist II, MedImmune
- Rudy
Smallwood, Associate Scientist II, MedImmune
- Dieter
Fassnacht,
Ph.D, Engineering Consultant, Talecris Biotherapeutics, Inc.
- David
Himes, Principal Simulation Engineer, BioKinetics Inc.
- Matt
Kennedy, Sr. Process Engineer, CRB Consulting Engineers, Inc.
- Sam
Gabrielli, Senior Strategic Planner – Process Research
& Development, Genentech, Inc.
- Jeffrey
P. Welch, Sr. Project Manager - Technical Services, Human
Genome Sciences, Inc.
- Prasad
V Saraph, Supply Chain Excellence Manager, Bayer HealthCare
LLC
- Carlos
Escobar, Senior Manager/Principal Engineer, Process Engineering
Group, Amgen
AGENDA
|
Tuesday,
11 November |
| 8:00-8:15
am |
Opening
Remarks - Course Introduction and Overview
- Philip Lyman, Director,
Process Simulation, CRB Consulting Engineers, Inc. |
| 8:15-10:00
am |
Biotech
Supply Chain Planning Optimization
This session will start with an introduction of Biotech Supply Chain
(nature of supply chain, similarities and differences with other
industries). It will then highlight planning challenges faced in
mid-term and short-term planning, followed by the case study at
Bayer HealthCare of utilizing Mixed Integer Programming to address
the planning challenges, implementation issues and key learnings.
- Prasad
V Saraph, Supply Chain Excellence Manager, Bayer HealthCare LLC |
| 10:00-10:30
am |
Coffee
Break |
| |
Case-Study:
Capacity Testing with Schedule-Based Modeling
Human Genome Sciences will present a schedule-based model used to
explore the capacity of an existing plant with a known process.
The model exposed limitations in the equipment as the predicted
utilization rates were increased, and de-bottlenecking options were
explored.
- Jeffrey
P. Welch, Sr. Project Manager - Technical Services, Human Genome
Sciences, Inc. |
11:15-Noon |
Using
simulation to handle an uncertain developmental pipeline
Planning for adequate production capacity is particularly difficult
when the required number of batches and the scales required are unknown.
This is frequently the situation for biotech process development facilities.
New products will require process development runs, later stage products
may require clinical supplies. If these products are successful they
may return later in the year at larger scales. In this session, we
will demonstrate the use of discrete event simulation to study this
type of problem. The result is a sequence of facility expansions required
to meet the demands of a probabilistic development pipeline.
- Philip Lyman, Director,
Process Simulation, CRB Consulting Engineers, Inc. |
|
Noon-1:00 pm |
Lunch |
|
1:00-3:00
pm |
Post
Commercialization Launch Optimization for Biotech Unit Operations
This session will discuss post commercialization launch optimization
strategy and a platform for a specific biotech process engineering
role. Different case studies linked to process improvements including
chromatography, ultrafiltration/diafiltration and column packing
unit operations will be presented. All case studies are driven initially
via process bench scale and pilot scale simulation including the
use of multivariable analysis (MVDA) to drive the right DOE and
optimization plan. At-scale engineering and validation-runs data
will also be presented to establish process optimization comparison
from bench to commercial scale.
- Carlos
Escobar, Senior Manager/Principal Engineer, Process Engineering
Group, Amgen
|
| 3:00-3:30
pm |
BREAK;
coffee/refreshments |
| 3:30-5:00
pm |
A
Case Study: Using Process Simulation to Identify and Resolve Potential
Bottlenecks in a Clinical Manufacturing Facility
MedImmune will lead an in-depth discussion on process simulation analysis
recently performed to identify labor, equipment and utility constraints
to maximize plant productivity for a new multi-product manufacturing
plant. The presentation will include a description of the process
simulation models built by the team, as well as techniques used, for
several monoclonal antibody processes using process simulation software.
- John
Higgins and Rudy Smallwood, Associate Scientist II, MedImmune |
5:00-6:00
pm |
Keynote |
| 6:00-7:00
pm |
Cocktail
Reception (with Exhibitors) |
|
Wednesday,
12 November |
| 8:00-9:00
am |
Case
Study: Applying Process Modeling to ensure successful front-end
process engineering for a new Fractionation Facility
This presentation will demonstrate process engineering
methods used in front-end engineering of a major capital project.
Discussion points will include a method to deal with concurrent
process development during engineering, building an efficient process
flow & material balance to allow simple process modeling in
Excel and applying SchedulePro as a simulation tool for more complex
evaluations.
-
Dieter Fassnacht, Ph.D., Engineering Consultant, Talecris Biotherapeutics,
Inc.
|
9:00-10:00
am |
Case
Study: Increasing throughput of a small to mid-size biopharmaceutical
manufacturing facility
In this Case Study, a small biopharmaceutical facility was evaluated
using process simulation tools to determine optimum approaches to
increasing throughput. The impact on facility infrastructure of increasing
throughput by increasing staffing levels and by increasing the number
of batches produced will be shown along with facility design improvements
to overcome the limits discovered. The methodology used to discover
facility infrastructure limits with regards to purified water consumption,
WFI consumption and waste permit levels (sulfates, ammonia, BOD, etc…)
will be discussed during the session.
- Philip Lyman, Director,
Process Simulation, CRB Consulting Engineers, Inc. |
| 10:00-10:30
am |
Coffee
Break |
| 10:30-Noon |
Process
Simulation and Optimization
- David
Himes, Principal Simulation Engineer, BioKinetics Inc. |
| Noon-1:00
pm |
Lunch |
| 1:00-3:00
pm |
The
Role of Process Simulation and Scheduling Tools in the Development
and Manufacturing of Biopharmaceuticals
This
presentation will review the state of the art in batch process simulation
and scheduling tools and their applications in the development and
manufacturing of biopharmaceuticals. The following topics will be
covered using examples that deal with the production of monoclonal
antibodies (MABs) and vaccines: 1) Cost of goods analysis and the
impact of disposables on cost and utilities, 2) Cycle time reduction
and uncertainty analysis, 3) Modeling and design of multi-product
facilities, and 4) Production planning and scheduling of multi-product
facilities. A methodology for sizing water for injection (WFI) systems
and bio-waste treatment utilities will also be presented.
- Demetri
Petrides, Ph.D., President, Intelligen, Inc. |
| 3:00-3:30
pm |
BREAK;
coffee/refreshments |
|
3:30-4:15
pm |
Session
TBD
- Matt Kennedy, Sr. Process Engineer, CRB Consulting
Engineers |
| 4:15-5:00
pm |
OPEN
DISCUSSION |
REGISTER
NOW! Visit www.asmeconferences.org/Bioprocess08
ASME
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