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Terrapinn Ltd, Radisson Hotel Boston, Boston, USA
October 15 - 17 2003
Day One Wednesday 15th October 20038:00 Registration and coffee
8:30 Opening presentation by Janice Bourque, President, Massachusetts Biotechnology Council
8:45 Moderator’s opening remarks
9:00 Process improvement through operational excellence
9:40 Eli Lilly's strategy to build a new facility to produce bulk protein API for clinical trial manufacturing needs
10:20 Transforming development operations into manufacturing operations
10:50 Morning coffee
11:30 Strategic supply chain management - the key to creating more predictable resources and capacity
12:00 Case study: employing capacity profitably by moving from a single use to multi-use facility
12:30 Innovation strategies – some reflections on implementation in operations
13:00 Lunch
14:30 Moderator’s opening remarks: considerations impacting the make vs buy decision
14:45 Biomanufacturing strategies: an industry overview
15:15 Balancing a portfolio of manufacturing in-house and outsourcing
15:45 Case study: new large scale cell culture facility
16:15 Afternoon tea
17:00 Case study: securing commercial scale cell culture manufacturing capacity
17:30 Outsourcing: strategic alliances for managing supply from the clinic to the market
18:00 Case study: optimal technology transfer between client and contract manufacturer
18:30 Close of day one and cocktail reception
Day Two Thursday 16th October 2003 8:50 Moderator’s opening remarks
9:00 Establishing a high yielding biomanufacturing technology platform
9:35 Manufacturing process development and comparability studies for Humira
10:10 Case study: recombinant human albumin production
10:45 Morning coffee
11:30 Improving throughput and viral clearance in protein purification
12:00 Integrating microbial expression of antibody domains into therapeutic product development
12:30 Case study: rapid and efficient production of aglycosylated full-length IgGs in E. coli
13:00 Lunch
14:30 The challenges to improving mammalian expression systems
15:00 Moderator’s presentation: bottlenecks in DNA manufacture
15:45 Case study: manufacturing pDNA for therapeutic use
16:30 Afternoon tea
17:15 Large scale GMP plasmid DNA production, formulation and fill-finish
17:45 Cost effective manufacture of autologous products – fact or fiction?
18:15 Close of day two and cocktail reception in the exhibition area
Day Three Friday 17th October 2003 8:45 Moderator’s opening remarks
9:00 Keynote presentation: balancing new technology innovation and introduction with regulation
9:40 The effect of the FDA’s new initiatives on regulatory compliance
10:20 Morning coffee
11:00 Assuring compliance of effective technology transfer to commercial scale up
11:30 ncorporating supplier validation data and services to facilitate compliance
12:00 Topic to be confirmed
12:30 Lunch
14:00 Moderator’s presentation: the production of therapeutic proteins in transgenic maize seed
14:30 Regulation of agricultural biotechnology: assuring safety for the next generation of products
15:00 The economics of product-specific bioprocess development and scale-up for recombinent base biopharmaceuticals
15:30 Afternoon tea
16:00 Current status of alfalfa-manufacturing technologies for the production of biopharmaceuticals
16:30 Revising protein purification using plant oilbody technology
17:00 New advances in transgenic animal systems for biological production
17:30 Close of conference
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Invited Speakers:
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Key speakers include: Dr Lester M. Crawford, DVM, Deputy Commissioner, FDA
Dr Victor Vinci, Head, Bioprocess Operations, Eli Lilly
Dr Don Bergmann, General Manager, Biopharmaceuticals, GlaxoSmithKline
Dr Brian Turner, Director, Process Sciences, Abbott Bioresearch Center
Dr David Broad, Vice President, Biological Bulk Manufacturing, IDEC Pharmaceuticals
Matt Ottmer, Director, Global Planning and Material Management, Biogen
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