Flexible Facilities

Market Needs, Products and Geographies Is Rapidly Emerging
Tuesday, April 2, 2013
7:00 Registration and Coffee
8:00 Chairman’s Remarks
Thomas Seewoester, Ph.D., Executive Director, Clinical Drug Substance
Manufacturing, Amgen, Inc.
Changing Industry Dynamics That Are Driving the
Need for Flexible Facilities
8:05 Impact of Integrated Continuous Bioprocessing on the
Design of the Manufacturing Facility of the Future
Abstract not available at time of print. Please visit
www.IBCLifeSciences.com/Facilities for updates.
Konstantin Konstantinov, Ph.D., Vice President, Late Stage Process
Development, Genzyme, a Sanofi company
8:40 Current and Future Trends in Biopharmaceuticals:
Biosimilars, Biosuperiors and Novel Biopharmaceuticals
This presentation discusses past and current sales of biopharmaceuticals,
biosimilars and biobetters. The current product trend will then be expanded
by looking into the future and the pipeline of biosimilars, biosuperiors
and novel biopharmaceuticals. Specific product and therapeutic examples
will be given. The current and future product trend will then be analyzed
and predictions about the demands of biopharmaceutical development,
operations and facilities will be made.
Johannes Roebers, Ph.D., Executive Vice President, Head of Operations,
Elan Pharma International Limited, Ireland
9:15 Trends in Biomanufacturing Facility Design and Operation –
Integrating the People, Technical, Regulatory and Procedural
Elements to Provide Flexible, Cost-Effective and High
Quality Capability
Bioprocessing of bulk drug substance biologics has changed and developed
significantly over the past decade. Industry capacity comprising large
scale facilities are being supplemented with a new generation of smaller
scale, highly flexible multi-product plants. This evolution is challenging
but technical and procedural innovations are enabling them to be met
economically whilst potentially improving product quality and patient safety.
This presentation describes how diverse concepts and technologies are
coming together and how new skills and capabilities are critical to success.
Simon Chalk, Director, BioPhorum Operations Group (BPOG), United Kingdom
9:45 Panel Discussion: What Defines a Flexible Facility
• Does it mean easier facility validation and fewer regulatory hurdles
• Does it mean quick facility deployment and production ramp up
• Does it mean disposables Or modular Or open ballroom
• Does it mean multi-product facilities Or easier scale-up capability
• What does “flexible” mean for stainless steel production facilities
Moderator:
Thomas Seewoester, Ph.D., Executive Director, Clinical Drug Substance
Manufacturing, Amgen, Inc.
10:15 Networking Refreshment Break with Exhibit and Poster Viewing
Hosted by:
New Concepts in Flexible Biomanufacturing Facility Design
10:45 Continuous Processing in Biotech Production as an
Alternative to a Modern Batch, Single-Use Facility
Drug, and in particular, process development during clinical phases is
required to be fast and flexible. As a result, the current operation mode
in biotech processing is batch. The addition of single use, skid-mounted
and closed systems in a ballroom type concept are introduced, keeping in
mind flexibility and time to market. Is biotech continuous processing an
option What are the potential advantages of a fully single-use continuous
process and can this be an alternative to the modern, smaller scale batch
operation This presentation discusses these questions and anticipates the
opportunities and challenges.
Thomas Daszkowski, Ph.D., Vice President, Process Technology,
Bayer Healthcare, Germany
11:15 CASE STUDY Flexible Facilities – What Does it Mean from a
Design Perspective
Today’s challenge is to create flexible biopharmaceutical operations to meet
internal research, clinical and market-entry requirements while minimizing
cost and maximizing speed, flexibility and efficiency. DSM has designed
a blueprint for commercial manufacturing facilities to produce 500kg of
biopharmaceuticals annually on a footprint as low as 87.000 ft². This case
study discusses some of these facility design implications:
• Open plan approach to clean room design; mobile equipment
• Flexibility in handling a variety of cell culture processes and bioreactor sizes
• 100% Single-Use upstream equipment
• Minimal cleaning/sterilization validation needed
• HVAC units design to prevent cross-contamination of the air
• Increased process effectiveness while minimizing environmental impact
• Less water and energy consumption
• Lower waste production
Francis B. Maddalo, Vice President Operations/Facility Development,
DSM Biologics
11:45 Accelerate Local Production: Quality and Speed with Cost
Control for the Biopharmaceuticals of the Future
The development of modular biomanufacturing facilities presents an
opportunity to meet local healthcare challenges of the future. Scalable
production of multiple biotherapeutics using single-use technology
platforms reduces capital costs and drives process efficiencies while
increasing operational flexibility and production capacity. Pre-fabricated
units and shorter assembly times improve planning and enable potentially
life-saving treatments to be delivered where they are needed more quickly.
Daniella Kranjac, Business Development Manager North America,
GE Healthcare Life Sciences
12:15 Networking Luncheon with Exhibit and Poster Viewing
Hosted by:
1:25 Chairman’s Remarks
Kenneth Green, Ph.D., Director, Technical Services, Pfizer, Inc.
Rapid Deployment and Global Market Localization
1:30 Portable Manufacturing Solutions for Market Localization
With the advent of single-use technologies, the opportunity to couple process
steps within closed systems is feasible. Furthermore modularization of
manufacturing platforms could enable rapid start-up and flexibility for localized
manufacturing operations with replication in other markets. This presentation
discusses current experiences in market localization and associated challenges.
Kenneth Green, Ph.D., Director, Technical Services, Pfizer, Inc.
2:00 Panel Discussion: A Comparison of
Sponsored by:
Real World Flexible Facility Approaches
Based on M+W Group experience in the delivery of
Flexible Facilities around the world, a comparison of
executed projects illustrates the pros and cons as well
as the commonalities of the various approaches (stand-alone modules,
component construction and conventional construction) to Flexible Facilities
for biomanufacturing that are being applied in the marketplace. The analysis
is made, using three recently delivered projects, by the project executives that
led the project teams. The panel discusses:
• How fast is fast Is the rapid development of GMP process suites and
facilities (9 to 12 months to engineering lots) really possible
• How flexible are these “standard” approaches
• What are the real economics of the various approaches
• What are the limits to the various approaches
• What are the regulatory and quality hurdles that need to be addressed
Panelists:
Peter Cramer, Vice President - Life Sciences Facility Design, M+W Group
H. Steven Kennedy, Director, Life Sciences + Chemicals, M+W Group
William Jacobsen, BioProcess Specialist, M+W Group
George Wiker, Principal, LifeTek
For up-to-date program information and new abstracts, visit: www.IBCLifeSciences.com/Facilities 3