June 1, 2008
Come join the staff of BioProcess International at the Biotechnology Industry Organization’s 2008 International Convention in San Diego, 17–20 June. As organizers of the BioProcess Product Focus Zone in the BIO Exhibition Hall, we will look forward to seeing you at our Booth #2438. Not only will you have a chance to visit with our exhibitors, but attendance is free at the zone’s Process Theater. There, for the second year in a row, a number of industry experts and exhibitors will present the latest information about developing processes and products — offering vital information on the changing landscape(s) of this dynamic industry. Below is the schedule information available at press time. Updates and more detailed abstracts are available online at www.bio2008.org and at www.bioprocessintl.com
Tuesday, 17 June 2008
3:45–4:10 Howard L. Levine, president and principal consultant, BioProcess Technology Consultants, Inc.: “Efficient Project Management of Biopharmaceutical Development: Ensuring On-Time and Compliant Development Programs”
4:15–4:40 Pete Latham, president, Biopharm Services: “Mergers and Acquisitions for Biotech Suppliers and Their Impact on the End Users”
4:45–5:10 Jeffrey Abbey, vice president of business development, Argos Therapeutics: “Dendritic Cells for Active Immunotherapy: Optimizing Design and Manufacture to Develop Commercially and Clinically Viable Products”
Wednesday, 18 June 2008
10–10:25 John Avellanet, managing director, Cerulean Associates LLC: “Lean Outsourcing”
10:30–10:55 Dr. Pieter de-Geus, vice president, research and development, DSM Pharmaceutical Products: “Biopharmaceutical Protein Production Using Aspergillus niger”
11:00-11:25 Ian Fitzpatrick, manager, manufacturing innovation, Invetech: “Automating Tailored Vaccine Processing”
11:30–11:55 Joe Wyse, PhD, president and CEO; and Vadim Klyushnichenko, PhD, vice president, pharmaceutical development, Coldstream Laboratories Inc, Lexington, KY: “Commercialization of an Academic Pharmaceutical Center into a Fully Integrated Contract Development and GMP Manufacturing Facility”
12:30–12:55 Crawford Brown, CEO of Eden Biodesign: “Translational Process Development: From Data to Approved Vaccines — the Art of Complex Vaccine Development”
2:00–2:25 Dr. Steve Pettit, senior scientist bioprocessing applications, Invitria: “Increased Cell Productivity Using Recombinant Human Serum Albumin”
2:30–2:55 Dr. John Chon, director, upstream process development, PERCIVIA: “Advances in XD Process Development with PER.C6 Cells”
3:00–3:25 Maree Devine, Novozymes: “Cells Love Protein, So What Has Driven the Protein Free Trend in Media Optimization?”
3:30–3:55 Lou Bellafiore and Thomas Malone, PhD, TechniKrom, Inc.: “Use of Inline Buffer Dilution and pH Adjustment for cGMP Bioprocessing”
4:00–4:25 Siddharth J. Advant, PhD, principal and head, west coast, Tunnell Consulting: “Selection and Managements of CMOs — Partnering for Success”
4:30–4:55 Shawn Laymon, PerkinElmer: “Reduced Regulatory Compliance Burden Through Adopting a Consolidated, Metrology-Based Analytical Instrument Qualification Strategy”
Thursday, 19 June 2008
10:00–10:25 Andy Walker, Jason Carstsen, and Jacob Peter Jensen, CMC ICOS Biologics Inc., Bothell, WA, USA and CMC Biologics A/S, Copenhagen, Denmark: “A CMO’s Perspective on Future Mammalian Production Facilities Design and Operation”
10:30–10:55 Dirk Karsten Beth, President, Mission3, Inc.: “Software as a Service: An Essential for Life Science Companies”
11:00–11:25 Dr Nicole O’Brien, commercial development manager, USA, Avecia: “pAVEway™ Advanced Protein Expression: A Novel Platform for Therapeutic Protein Production”
11:30–11:55 M. Rita Geiger, CEO/president and founder, Info Strength: “E-Submissions: Current Challenges and Ways to Overcome Them”
12:30–12:55 François Arcand, CEO of ERA Biotech: “Zera® — Improved Eukaryotic Cells: In Vivo Encapsulation, Product Concentration and Affinity Capture of Recombinant Proteins”
2:00–2:25 Stewart Craig, PhD, vice president and chief technical officer, PhD, Progenitor Cell Therapy LLC: “Integration of Bioprocessing Technologies for the Commercial-scale Manufacture of Autologous Cell-based Therapies”
2:30–2:55 Ian Sellick, Pall Corporation: “What’s Hot? (New Technologies Up- and Downstream)”
3:00–3:25 Igor Fisch and Andrew Sandford, Selexis: “Technologies for Cell Line Engineering and Expression of Recombinant Proteins and Their Application Across the Biotechnology Industry”
3:30–3:55 Susan Dana Jones, vice president and senior consultant, BioProcess Technology Consultants: “Challenges in Scaling Up Newly Developed Microbial Manufacturing Processes”
4:00–4:25 Roberta Morris, Director of Marketing and New Product Development, Charter Medical, Ltd., director, Bio-Process Systems Alliance: “Bio-Process Systems Alliance: Advancing Single Use Worldwide”
4:30–4:55 Brian Hampson, Aastrom Biosciences: “Manufacture of Patient-Specific Cell Therapy Products”
North American Featured EventBioProcess International Conference and Exhibition23–26 September 2008 Disneyland Hotel, Anaheim, CA
Building on the success of the past four years, a 2008 program was developed for this maturing industry by expert end-users and the IBC research team. This year, the agenda focuses unwaveringly on methods to slash time to market and cost of goods, to dramatically accelerate development of robust processes, to achieve higher-than-ever yields from cell culture, and to break through the downstream bottleneck. The program allows you to choose among four in-depth tracks with presentations from industry leaders as well as emerging, small- to medium-sized companies so you can customize your own BPI experience.
Track Highlights
Track #1: Production and Economics of Biopharmaceuticals. Highlights include strategic planning for biopharmaceuticals (challenges for a maturing in
dustry), production planning for cost-efficient manufacture when demand is uncertain, and improving competitiveness and quality of biopharmaceuticals.
Track #2: Scaling Up from Bench Through Commercialization. Highlights include knowledge management strategies to leverage and exploit process data to accelerate process development, regulatory updates including tools for implementation of quality by design, and advances in process models to enable improved scale-up and technology transfer.
Track #3: Cell Culture and Upstream Processing. Highlights include approaches to reduce timelines and manage instability in cell line development, achieving 10+ grams per liter and overcoming the challenges of process development, and exploring different development paths to higher productivity and improved quality.
Track #4: Recovery and Purification. Highlights include alternative approaches to overcome challenges of large-scale protein production, implementation of a two-step purification process for monoclonal antibodies, and platform development approaches for nonplatform projects (processes for nonantibody drugs).
New for 2008
New program features include
Exhibit hall presentations with visionary Keynote Plus innovative technology launches and demonstrations
A high-level discussion forum on strategies for adopting new technologies with an industry–supplier panel on downstream technology needs
The “Pre-Event Online Partnering System,” an online community for scheduling meetings in advance
A plenary session featuring US FDA and high-level industry speakers who tackle the need to modernize and make changes in a highly regulated environment where risk is difficult to estimate. By attending, you’ll hear influential thought leaders address the all-important challenges of postregistration changes and implementing quality by design.
This year’s conference offers more in-depth coverage:
Increased focus on reducing cost of goods and timelines for speed to market and competitiveness
Comprehensive coverage of biopharmaceutical manufacturing from strategic planning through nuts and bolts technology case studies
>110 scientific podium presentations, >50 posters, 40 cutting-edge case studies, and small group networking discussion and problem-solving sessions
Expanded opportunities to hone your skills with preconference workshops on technology transfer, single-use processes, and process characterization and monitoring.
Featured Presenters
Robert L. Garnick, senior vice president in regulatory quality and compliance at Genentech, Inc.
John K. Towns, director of global CMC regulatory affairs at Eli Lilly and Co.
Jeanne Holm, chief knowledge architect at NASA Jet Propulsion Laboratory
Rick Rutter, vice president of pharmaceutical sciences in biologics at Pfizer Inc.
Konstantin Konstantinov, vice president of technology development at Genzyme Corp.
Rob Bryant, vice president of quality and lead master blackbelt in the Lean/Six Sigma program at Computer Sciences Corporation
Charles L. Cooney, faculty director of the Deshpande Center of Technological Innovation and Robert T. Haslam (1911) professor in the department of chemical engineering at the Massachusetts Institute of Technology
Steven Kozlowski, director of the Office of Biotechnology Products at CDER (US FDA)
Anthony Mire-Sluis, executive director of global product quality and external affairs at Amgen
Robert A. Baffi, senior vice president of technical operations at BioMarin Pharmaceutical Inc.
Register early and maximize your savings. Mention priority code B8171BPIFE. More than 1,500 attendees and 150 exhibitors are expected. Site tours will visit Irvine Scientific and Genentech’s 2007 facility of the year.
European Featured EventImmunogenicity for Biologics16–17 September 2008 Steigenberger Hotel, Hamburg, Germany
#CITY CENTER, HAMBURG, GERMANY, BY MARK[#x000C9]TA SKORNICKOV[#x000C1] (WWW.SXC.HU)
Join us in Hamburg to hear presentations from international experts on how to successfully develop screening, confirmatory, and neutralizing immunogenicity assays. Our interactive panel sessions will ensure that you gain the most from this four-day event. And don’t miss our 14 case studies. Learn from presenters with hands-on, practical experience, and those lessons that back to your company. Our international body of speakers includes the following:
Daniel Kramer, corporate expert in immunogenicity at the Institute of Drug Metabolism and Pharmacokinetics of Merck Serono in Germany
Kelly Loyet, associate scientist at Genentech in the United States
Roy Jefferis, professor in the division of immunity and infection at the University of Birmingham in the United Kingdom
Robert Müller, formulation scientist at F. Hoffmann-La Roche in Switzerland
Daniel Baltrukonis, scientist at Pfizer in the United States
Eva-Maria Jahn, scientific staff member of the Paul Ehrlich Institute in Germany
Tudor Arvinte, professor of biopharmaceutics at the University of Geneva in Switzerland.
Find the rest of our speaker panel and further details on the conference agenda online at www.informa-ls.com/immuno
Highlights for 2008
Genentech, Pfizer, and the Health Protection Agency will present detailed case studies on neutralizing assays. This year, assay design and validation have been split into two separate sessions so you can gain an in-depth and thorough understanding of both challenging areas. With a whole day dedicated to these topics, you can be sure to come away with the tools to gain your own meaningful results.
Join leading academic and industry experts (Tudor Arvinte and Robert Müller, listed above) and learn to assess the impact of different formulations on the immunogenicity of biological drugs.
Incurred sample stability: With the FDA actively driving this forward, how can industry respond effectively? Stephanie Fischmann presents Abbott’s application of a homogeneous ECL bridging assay for determination of toxicology data for a MAb in monkey serum with incurred sample reanalysis (ISR).
In April 2008, the EMEA guidelines on immunogenicity assessment of biotechnology-derived therapeutic proteins came into effect. Join presenters from the Paul-Ehrlich-Institute to assess the impact of these guidelines on your company.
Risk management strategies: What studies should be done for risk management? How many patients should be committed to a study? Minimize the risk of immunogenicity for your drug product by learning from a detailed case study presented by MerckSerono.
And don’t miss…
Our popular preconference workshop on “Detection and Characterization of Immunogenicity for Therapeutic Biologics,” with Daniel Kramer of MerckSerono in Munich on Monday, 15 September 2008.
And a postconference workshop on Thursday, 18 September 2008: “Addressing Immunogenicity Issues in Scientific Advice Procedures with European Regulators.”
Quotes
Previous attendees have found “a good amount of information covering the whole of the immunogenicity field” (Eurofins Medinet, September 2007) and “excellent insight into technologies used in the field. Interesting information on regulatory issues” (Organon, February 2007).
To save up to €400 if you book before 13 June 2008, please quote your VIP code: CQ3371BPIAD. Call our booking hotline on 44-20-7017-7481 or send an email to .
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