The BIOPHEX 2004 Conference, presented by Genetic Engineering News, helps

Thursday 1st of January 1970 1:00

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.

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