June 1, 2009
IBC’s BioProcess International Conference and Exhibition (BPI) will head back to the US east coast for 2009 to Raleigh, NC. This has become the largest, most respected forum focusing on technical, regulatory, and strategic planning challenges in the manufacture of biotherapeutics. Four comprehensive conference tracks as well as intimate workshops, strategic discussion groups, training seminars, and colocated conferences will continue to provide you with an interactive and lively format all in one location. BPI allows you to meet face-to-face with industry experts and colleagues across various disciplines of biopharmaceutical manufacturing — to get the answers you need to move your company forward. An expanded exhibit hall (which was sold out in 2008) will showcase the latest array of technologies and services from more than 150 exhibitors, giving you the chance to compare and evaluate the best products on the market.
In addition to the regular conference programming, all BPI Conference attendees will have access to the colocated 9th annual Formulation Strategies for Protein Therapeutics Conference. Diosynth (part of Schering Plough Corporation) offers a facility site tour, and Lonza will present a special sponsored session. Attendees also have the opportunity to add one of three professional development training courses (colocated at the convention center) to their conference package.
To Register
Early registration discounts are currently available. You may register online or by calling 1-800-390-4078. Please mention code B9171BPIFE when registering.
Four Conference Tracks
Manufacturing Efficiency and Supply Chain Security
Scaling Up from Bench through Commercialization
Cell Culture and Upstream Processing
Recovery and Purification
Preconference Symposia
Technology Transfer
Practical Aspects of Implementing QbD
Driving Out Costs from Biomanufacturing
New Sessions this Year
Integrating Upstream and Downstream Processing
High-Throughput Process Development
Applying Analytical Methods to Downstream Processing
New Therapeutic Modalities
Process Monitoring
Technologies to Measure and Control Processes
Incorporating Manufacturability in Upstream Processing
Numeric Methods to Understand Process Data
Process Quality and Characterization
Use and Validity of Scale-Down Models
Product Lifecycle Management
Minimizing Variability of Process and Product
Supply Chain Integrity Including Oversight Management and Risk Assessment
Disruptive Technologies that Shape the Facilities of the Future
Vaccine Manufacturing Technology Summit
Strategy Discussion Forums
Media Development and Feed Strategies
Simulated Moving Bed Chromatography
Plant Capacity: Successful Strategies to Deal with Too Much of It
Back By Popular Demand: Adopting New Technology — Take 2
Biosimilars
Flexible Small-Scale Manufacturing Facility Scenarios
How Do We Manage Measurement Uncertainty in the Implementation of QbD?
Confirmed Keynote and Featured Presenters
G.K. Raju, executive director of the MIT Pharmaceutical Manufacturing Initiative (PHARMI) in the MIT Program on the Pharmaceutical Industry
Johannes Roebers, senior vice president and head of biologic strategy, planning, and operations at Elan Pharma International Limited
“Structure and Function of Heparin Polysaccharide Chains: Update on Recent Contamination Issues” by Ali Al-Hakim, branch chief of the Office of New Drug Quality Assessment at the US FDA’s Center for Drug Evaluation and Research
“Comparability Case Studies: Lessons Learned Over 13 Years of Experience” by Mary B. Sliwkowski vice president of regulatory CMC and information systems at Genentech, Inc.
Immunogenicity for Biologics
8–9 September 2009 — Andel’s Hotel (Prague, Czech Republic)
At “Immunogenicity for Biologics 2009,” regulators and industry will unite to reduce the risk of biological drugs. Critical insights delivered by leading industry and academic experts include a keynote address from Jaya Goyal (clinical science and technology, preclinical and development sciences at Biogen Idec in the United States). Gain essential feedback on real-life submissions to European regulators and the US FDA.
Neutralizing Assays: Learn how to design and validate with case studies from Biogen Idec, NIBSC, and the Health Protection Agency.
Cell-Based and Ligand Binding Assays: Examine the importance of lgG4 in immunogenicity assessment. Four different assays will be compared.
Regulatory Submissions: Gain regulatory and industry feedback on real-life submissions. What worked, and what didn’t? Ensure that your product will be first to market.
Predicting Immunogenicity: Assess the real value of animal models with Baxter Bioscience, and hear two case studies describing the benefits of cell assays.
Featured Speakers
Birgit Reipert, director of immunology in global preclinical R&D at Baxter BioScience in Austria: “Use of Animal Models for Assessing Immunogenicity of Protein Therapeutics in Preclinical Development”
Viswanath Devanarayan, director of exploratory statistics at Abbott in the United States
ANDEL’S (WWW.ANDELSHOTEL.COM)
Bernardo Perez-Ramirez, scientific director of bioformulations development at Genzyme in the United States: “Controls in Protein Aggregation and Self-Association: Role of Formulation and Process Development”
Bassam Hallis, project manager at the United Kingdom’s Health Protection Agency: “Validation of Neutralizing Assays”
Roy Jefferis, professor in the school of immunity and infection at the University of Birmingham in the United Kingdom: “Antidrug Antibodies: Significance and Interpretation of the Isotype Profile”
Ingrid Ottevaere, associate scientist at Ablynx in Belgium: “Successfully Implementing Screening and/or Confirmatory Assays”
Isabel Büttel, scientific officer at the Paul Ehrlich Institute in Germany: “Feedback from European Regulators on Real-Life Submissions”
Sessions, Day One: Tuesday, 8 September 2009
Neutralizing Assays: Design and Validation
Challenges of Screening and/or Confirmatory Assays
Cell-Based Assays vs. Ligand Binding
Breakthrough Advances with Immunogenicity Assays
Real-Life Regulatory Submissions
Sessions, Day Two: Wednesday, 9 September 2009
Preclinical Studies: Predicting and Reducing Immunogenicity
Clinical Case Studies
Impact of Formulation and Aggregation on Immunogenicity
Biosimilar Drugs
To Register
Save up to £400 if you book by 3 July 2009 and quote VIP Code “CQ3389FBPI.” Call 44-20-7017-7481 or send email to .
You May Also Like
