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By Kevin
Richards Industry
Vice President, Reed Exhibitions As increasing
numbers of biopharmaceutical products emerge from the laboratory and into
production, plotting the right path to market becomes more important than ever.
Until now, the biopharmaceutical industry has concentrated most of its
problem-solving efforts on discovery. Today, the emphasis is quickly shifting to
manufacturing issues—and the pressure is on to solve the complex challenges of
capacity, quality, knowledge management, drug delivery and process innovation. The path from
post-discovery to commercialization can be a bumpy ride, with many detours,
delays and roadblocks along the way. If you take a wrong turn at any point, a
promising drug may languish in regulatory limbo. Move too slowly, and the
opportunity to recoup research and development costs can disappear. The BIOPHEX
2004 conference, developed by Genetic Engineering News, provides a roadmap
designed to guide senior managers, engineers, scientists and others through the
unfamiliar, often confusing territory from scale-up to commercialization, and
beyond. This year’s
cutting-edge program is led by a respected faculty from industry leading
companies such as Aegis Analytical, Cardinal Health, Transgene and VaxGen;
innovative solutions providers including Fluor Corporation, Sun Microsystems,
Inc., Rockwell Automation, ValiMation Inc. and Varian; prestigious educational
institutions, including the University of California at Berkeley, the University
of Massachusetts, Penn State and Northwestern University; and renowned
consulting firms such as the Juran Institute. These 48
must-attend sessions cover your “front burner” issues and provide specific,
actionable strategies to help you optimize process development, reduce cycle
times and costs, improve quality control, meet rigorous regulatory requirements,
incorporate new scientific and technical advances, and maximize the profit
potential of your product pipeline. Conference tracks include: The
shrinking biotech plant: strategies for lowering cost and improving efficiency
Whether
or not the industry faces a capacity crunch, it’s imperative to have a well
thought out strategy for meeting your production requirements. Learn how smart
scale-up strategies use biology, cellular engineering, genomics, process
efficiencies, economics, and quality-enhancing techniques to reduce capacity
requirements. Topics include: creative biotech engineering to meet the capacity
crunch; an approach to cell harvest optimization; miniplants: a modular approach
for distributed processing; and increasing plant efficiency through CIP
engineering. Drug
delivery as a strategic asset Explore
innovative approaches to enhancing drug efficacy and market potential through
novel formulations, delivery systems, and delivery devices. Topics include use
of nanoparticle-laden soft contact lenses for ophthalmic drug delivery;
molecular engineering and evolution of enhanced viral gene delivery vehicles;
adapting controlled release technologies to the delivery of DNA, and more. Knowledge
management and transfer From
bench to development into manufacturing, inputs from biology, chemistry,
regulatory, and accounting are critical at every juncture of biopharmaceutical
development. Sessions in this track include: information management resources in
life science discovery; the business challenges of knowledge transfer; a recipe
for blending small biotech firms with industry giants; the value of electronic
data capture and its influence on ROI. Implementing
process innovation Case
studies of successful, "radical" process innovations show how
companies deal with technical and process innovation in real-life situations.
Session topics include: extreme bioprocessing; low-cost sensor technology for
high throughput bioprocessing and integrated process development; a risk-based
approach to compliance; and error-proofing the pharmaceutical supply chain with
RFID. Process
innovation in practice When
is the right time in a product's life cycle to innovate, how do you go about it,
and how much innovation is just right? Explore these issues in sessions that
examine: using technology to automate system design, implementation, and
validation; developing CMC information from laboratory investigations; mixing
considerations at the pilot plant stage in bioreactors; and improving efficiency
through automation. Management
approaches to reducing error and streamlining operations Learn
how to implement advanced management, training, Six-sigma, lean manufacturing,
and other techniques for improving quality and productivity while reducing
product variability and accidents. Choose from six in-depth sessions that cover:
integrating lean and six sigma; using value stream mapping for lean
manufacturing improvements; leveraging PAT to increase operational efficiency
and reduce human error; and transferring benchtop success to full GMP process
scale HPLC. Next step:
how to apply what you’ve learned Having a plan
of action is only the first step in your problem solving process. You also need
technologies, equipment and services from qualified vendors to implement
state-of-the-art solutions—and that’s exactly what you’ll find in the
BIOPHEX exhibit hall. During and after the conference sessions, you can meet
with many of the industry’s most innovative suppliers, including AssurX, Inc.;
Baxter Pharmaceutical Solutions; Carlisle Life Sciences; Document Control
Systems, Inc.; Ecolab, Inc.; Flow Sciences, Inc.; GEA Liquid Processing;
Harrington Industrial Plastics, Inc.; International Process Solutions; JVNW,
Inc.; Biotest Diagnostic Corporation; L.B. Bohle LLC; Meissner Filtration
Products; Niro Soavi; OSI Soft, Inc.; Pall Life Sciences; Quadrants Scientific,
Inc.; Roplan, Inc.; Steris Corporation; Tescom Corporation; Validation
Technologies, Inc., all demonstrating their most advanced solutions for every
stage of the post-development, scale-up and commercialization process. Your buying
team will have the opportunity to see, touch and compare solutions in a wide
range of categories, from analyzers, bioreactors and cell culture to validation
software and water purification technologies, and much, much more. The BIOPHEX
2004 conference will take place September 28-30, 2004 at the Moscone Convention
in San Francisco, California. The exhibition opens on Wednesday, September 29.
For complete event information (including an up-to-date exhibitor list and floor
plan, conference details, special events and convenient on-line registration)
please visit the BIOPHEX web site, http://www.biophex.com. DOWNLOAD BIOPHEX 2004 CONFERENCE PDF BROCHURE!
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