Program Information - IBC Life Sciences

Agenda Overview (Includes Room Assignments)
Monday, September 20, 2010
1:00 pm - 5:00 pm
Symposium #1: Prevention of Microbial and Viral Contamination of
Mammalian Cell Culture Processes (Room 554)
Symposium #2: How Much Data is Enough
The Statistical Approach to Process Validation (Ballroom C)
Symposium #3: Technology Transfer for Biopharmaceuticals
(Ballroom E)
Tuesday, September 21, 2010 Exhibit Hall Hours: 5:30 pm – 7:00 pm
Managing Manufacturing
Morning
Networks (Ballroom B/C)
Leveraging our Assets - How do We
Reconcile the Installed Base with Current
Technologies and Demand
Leveraging our Assets - How do We
Reconcile the Installed Base with Current
Technologies and Demand (session continues)
Product Lifecycle Management
(Ballroom D/E)
Process Design: Establishing Design Space
and Robust Process Parameters
9:45 am Networking Refreshment Break
Process Design: Establishing Design Space
and Robust Process Parameters
(session continues)
Sponsored Session by Bio-Rad
(Room 551)
Strategic Discussion Forum
(Rotunda)
Formulation Strategies for
Protein Therapeutics (Room 555A/556)
Advancements and Case Studies of
Hydroxyapatite for Biomanufacturing Pre-Conference Workshop:
The Formulator of the Future: Using High
Throughput Technologies, Informatics
and Rational Design to Accelerate and
Advancements and Case Studies of
Hydroxyapatite for Biomanufacturing
(session continues)
10:15 am
Managing Partners and Contractors
– Practical Solutions to the Issues that Arise
11:45 am Technology Workshops Sponsored by: Sheffield Bio-Science (Room 553), Mirus Bio (Room 550) and Novasep, Inc. (Room 552)
12:15 pm Luncheon Presentation Sponsored by Millipore Corporation (Ballroom A)
Afternoon
Smart Flexibility in Facilities Implementation and Execution
Networking Refreshment Break
Opening Keynote Presentations: I. Regulatory Modernization - FDA's Desired State for Product Quality
II. The Role of Biosimilars in Driving Innovation in the Biopharmaceutical Industry
(Ballroom A)
5:30 pm Opening Night Reception Sponsored by: Pall Life Sciences (Exhibit and Poster Hall)
1:45 pm
Manufacturing: What will Take Us to the
Next Level of Efficiency and Economics
Sponsored by Pall Life Sciences
Optimize Formulation Development
Keynote Presentations:
Holistic QbD; Particles, Particles Everywhere
Development of Formulation and Drug
Product Design Space
Comparability and Characterization Exercises
during Formulation Development
Comparability and Characterization
Exercises during Formulation
Development (session continues)
Wednesday, September 22, 2010 Exhibit Hall Hours: 9:45 am – 7:00 pm
Managing
Manufacturing
Networks (Ballroom B/C)
Product Lifecycle
Management
(Ballroom D/E)
Raw Materials/
Supply Chain
(Room 551)
Strategic
Discussion Forum
(Rotunda)
Recovery &
Purification
(Room 552)
Rapid Vaccine
Development and
Production (Room 555B)
7:15 am Technology Workshop with Continental Breakfast Sponsored by: SAFC Biosciences (Rotunda) Keynote Presentation: Global
Vaccine Production Challenges:
Emerging Immunotherapeutics,
Manufacturing Flexibility and
Morning
The Future of Manufacturing
Networks and Facilities
The Future of Manufacturing
Networks and Facilities
(session continues)
Continuous Process
Improvement
Continuous Process
Improvement
(session continues)
Point Counterpoint Session:
Integrating Raw Materials
and Suppliers into
a Pharmaceutical
Quality System
Advances in Process
Monitoring and Control in
Downstream Processing
9:45 am Networking Refreshment Break Sponsored by: Luminex (Exhibit and Poster Hall)
Point Counterpoint Session:
Integrating Raw Materials
and Suppliers into a
Pharmaceutical Quality
System (session continues)
10:30 am
Continuous Disposable
Multi-Column
Chromatography
Sponsored by Tarpon Biosystems
Cell Culture &
Upstream Processing
(Room 552)
Integrating In-Line Process
Monitoring and Control
Technologies
Reducing COGS
Lessons Learned from the 2009
Flu Season to Guide Rapid Vaccine
Development and Manufacturing
Scale Up
Process Development
for Novel Vaccines and
Immunotherapeutics
Formulation Strategies
for Protein Therapeutics
(Room 555A/556)
Keynote Presentation: Modeling
Protein Degradation Processes
and the Development of
Rational Approaches to
Stabilization
Keynote Presentation: NIST
Perspective on Standards and
GMP Processes for Subvisible
Particles in Protein Therapeutics
Implementing Analytical
Methods and Control Steps for
Subvisible Particles