Terrapinn Ltd, Radisson Hotel Boston, Boston, USA
18 - 20 October 2004
Day one Monday 18 October 20047:45 Registration and morning coffee Predicting and planning for a maturing industry 8:30 Moderator’s opening remarks: analysis of biologics manufacturing capacity
Dr Howard Levine, President, BioProcess Technologies Consultants 8:45 Keynote presentation: strategic planning for a growing pipeline of successful biologics
· Development of biologics - timelines and decision points, probability of success, capacity planning
· Management of capacity shortfall
· How to use existing capacity more efficiently
· Management of excess capacity
Dr Erich Hochuli, Head of Biotech Production and Development, F. Hoffmann-La Roche 9:15 Outsourcing and in-house development: options for speed to market
· An overview of options
· How outsourcing could help time to market
· Decisions on what, when and how to outsource
· Balancing outsourced and in-house technological strength and capabilities
Dr Michele Antonelli, SVP, Manufacturing, Serono International 9:45 The grace period is over – how biomanufacturing is coming of age
· Providing answers to capacity limitation and margin squeeze
· Innovation gaps in downstream processing
· Integrated manufacturing of biopharmaceuticals
· Trends in robust enabling technologies
Dr Uwe Gottschalk, Head GMP, Protein Manufacturing, Bayer AG 10:15 Morning coffee 11:00 Case study: predictive process models for a supply chain planning strategy
· The need for early cost analysis of processes
· Integration into overall product development strategies
· Model outputs and lessons
· Integration with biopharma operations
Dr Roland Heinrich, Senior Director, Strategic Operations Planning, Wyeth BioPharma 11:30 Panel session: core competencies and what to outsource
· Choosing the right model of outsourcing
· Creating a value chain with partners, concentrating on core competencies
· Maturing production systems as a driver of outsourcing
Panellists:
Mark Bamforth, SVP, Corporate Operations, Genzyme Corporation
Dr Erich Hochuli, Head of Biotech Production and Development, F. Hoffmann-La Roche
Dr Michele Antonelli, SVP, Manufacturing, Serono International
Bill Helming, Director, Life Sciences, Pittiglio, Rabin, Todd & McGrath 12:15 Lunch 13:45 Experiences in creating biomanufacturing operations in Europe and USA
· Overview of Genzyme’s 10 cGMP sites
· Compare and contrast experience of different countries
· Integration of multi-technology sites in an effective global supply chain
· Inward investment support from countries/states
Mark Bamforth, SVP, Corporate Operations, Genzyme Corporation 14:15 A modular case study for large biotech projects
· New and alternative fast track construction/installation
· Controlled off-site construction to reduce overall project lead time
· Managing the logistics
· Guaranteed pre-commissioned quality
Lars Turstam, Senior Project Manager, Pharmadule Emtunga AB Utilising process development opportunities to the max 14:45 Moderator’s presentation: why operational excellence yields robust, efficient processes
Amir London, Partner, Global Biopharmaceuticals, Tefen 15:15 Utilising technology platforms for process development’s contribution to product development
· Definition of technology platforms as operating parameters to produce a class of products
· Application of these technology platforms to develop process and analytical methods
· Reducing speed to clinic and increasing efficiencies for competitive advantage
Dr Geoffrey Slaff, VP, Process Development, Amgen 15:45 Afternoon tea 16:30 Accelerating programmes by integrating process development and research
· Challenge of integrating process strategy at an early stage
· How to build robustness into a process from the start
· How to build in final product quality during the R&D phase
· Challenge of early scale up
Dr David Thatcher, CEO, Cobra Biomanufacturing 17:00 Case study: meeting process challenges for antibody fusion proteins
· The challenges of producing antibody fusion proteins
· Issues surrounding product quality
· The strategy to enhance complex cell culture process robustness
· Lessons learned from a novel antibody fusion protein
Dr Steven Lee, Senior Director, Biotechnology Development and Operations, Bristol-Myers Squibb Company 17:30 Case study: manufacturing challenges for autologous products
· The general rationale for autologous products and their application for cancer treatment
· The key operational elements driving the manufacturing and quality framework
· The design of a practical and economic manufacturing process
Dr Neal Gordon, SVP, Manufacturing Operations, Antigenics 18:00 Close of day one – cocktail speed meeting hour
Day two Tuesday 19 October 2004
Compliance, risk and quality considerations for biomanufacturing 8:45 Moderator’s opening remarks
Scott Sarazen, SVP, Life Sciences, Mass Development 9:00 Keynote presentation: topic to be confirmed
Dr Christopher Joneckis, Senior Advisor For Chemistry Manufacturing and Control Issues, Office of the Center Director, CBER, FDA 9:30 Considerations in taking a quality system approach to regulatory programmes
· Integration of QMS metrics, strategic performance objectives and risk management
· Achieving outstanding operational performance and ongoing inspection readiness
· The need for communication to senior management,
· Ongoing compliance and successful stakeholder-based business results
Dr Michael Kowolenko, VP, Global Quality, Biogen Idec 10:00 Morning coffee 11:00 Implementing systems-based compliance at the plant level
· Using FMEA to self-assess and prioritise systems and compliance gaps
· Pitfalls that wreck corrective and preventive action implementation efforts
· Defending systems and sustaining readiness
· Successful agency and auditor interactions using a systems-based approach
Robert Bottome, Director of Packaging, Genentech 11:30 Panel session: what are the sources of manufacturing variability and do we truly understand them?
After 25 years, the FDA has been taking a fresh look at GMPs and asking if they have kept pace with technology and are practical, given the budgetary constraints of the agency. This new approach has forced the biomanufacturing industry to re-examine how they approach compliance, methods of validation and process efficiencies. The panel evaluates our understanding of the sources of manufacturing variability. It asks are we facilitating innovation whilst complying with regulatory changes?
Panellists:
Dr Jim Weston, VP, Corporate and Regulatory Strategy and MD, Cato Research
Dr Raafat Fahim, VP, Manufacturing Operations, Nabi Biopharmaceuticals
Dr Edward Arcuri, SVP, Manufacturing Operations, MedImmune
Robert Bottome, Director of Packaging, Genentech 12:15 Lunch The future of bio-similar products 13:45 Moderator’s opening remarks
Dr Jim Weston, VP, Corporate and Regulatory Strategy and MD, Cato Research 14:00 Current developments with respect to follow-on biologics in the US
· FDA’s position on Section 505(b)(2)
· Status of FDA guidance on scientific issues
· Review of political environment
· Other interested groups
Alan Bennett, Partner, Ropes & Gray 14:30 Case study: the immunogencity of biologics and implications for manufacturing
· Factors influencing the immunogenicity of therapeutic proteins
· Impurities and contaminants - how they appear
· The presence of aggregates by suboptimal production or formulation
· Routes of administration and patient characteristics
· Case study on the induction of antibodies
Dr James Green, VP, Pre-clinical and Clinical Development Sciences, Biogen Idec 15:00 Case study: manufacturing next generation biologics in Europe
· The framework for ordinary generic drugs in Europe
· The new framework for similar biological medicinal products
· New Annex I to Directive 2001/83
· CPMP guidance note on pre-clinical and clinical aspects of comparability for biotechnology products
· New article 10(4) of Directive 2001/83
· Pending litigation in the EC Court of First Instance
Richard Kingham, Partner, Covington & Burling 15:30 Afternoon tea 16:15 Plant-based manufacturing of biosimilar and next-generation biologics
· Gaining process FTO through alternative manufacturing
· COGS and supply advantages and impact on next-generation products
· Quality of PMB: case studies of plant-made therapeutic proteins and immunomodulators
· Regulatory experience
Dr Daniel Tusé, VP, Business Development, Large Scale Biology Corporation 16:45 Panel session: off-patent biologics comparability – how similar is similar enough?
· Existing guidance for biopharmaceuticals product comparability
· A clear interpretation of product comparability for regulatory approval of off patent biologics
· The issues and expectations of regulatory authorities surrounding product comparability
· Scientific challenges pertaining to process definition and product characterisation
Panellists:
Dr Roland Heinrich, Senior Director, Strategic Operations Planning, Wyeth BioPharma
Richard Kingham, Partner, Covington & Burling
Dr James Green, VP, Pre-clinical and Clinical Development Sciences, Biogen Idec 17:30 Close of day two
Day three Wednesday 20 October 2004 Optimisation of yields in cell culture and fermentation development 8:45 Moderator’s opening remarks
Bill Helming, Director, Life Sciences, Pittiglio, Rabin, Todd & McGrath 9:00 Approaches to improving the performance of mammalian cell cultures for protein production
· Creation of cell lines
· Choice of gene expression technology
· Improvements to host cell lines
· Selecting high producing clones after transfection, including high throughput clone screening
· Reducing cell line development times
· Optimisation of fermentation processes using chosen clones
Professor John Birch, CSO, Biopharmaceuticals, Lonza 9:30 Optimisation of process yield in biopharmaceutical manufacturing
· Expectations for such challenges
· Laying the foundations, rational design
· Dual approach: controlling loss and increasing productivity
· Case studies: strategies for upstream and downstream processing
· Tools for yield optimisation
Dr Christopher Dale, Senior Director, Operations, Cambrex Biopharmaceuticals 10:00 Critical factors in cell culture media development
· Implications and impact of media development on manufacturing
· Methodologies for conducting media development
· Case examples of improvements achieved in media development
· Options for conducting media development - in versus outsourcing
Parrish Galliher, Founder, President and CEO, xCellerex 10:30 Morning coffee
11:30 Optimisation of a high yielding expression system for protein production
· Metabolic characterisation of clones
· Improvement of fermentation processes
· Choosing optimal process parameters
· Comparison fed-batch vs. continuous perfusion
Dr José Coco Martin, Competence Manager, Mammalian Cell Technology, DSM Biologics 12:00 Using continuous perfusion cell-culture
· Is perfusion cell-culture still a useful approach?
· Current perfusion cell culture systems
· Scale-up and validation
· Capabilities at contract manufacturing organisations
Dr Philipp Hess, Founder and Managing Partner, Philipp Hess Associates 12:30 Lunch Safety issues for biomanufacturing 14:00 Prion removal by filtration: application to biotechnology drug manufacturing
· What are the risks from TSEs in biotechnology?
· What diagnostic tests are available to detect TSEs?
· Lessons to be learned from the blood fractionation industry
· Case studies and test work carried out using filter media to remove TSEs
· New filtration media that enhance removal
Jerold Martin, SVP, Global Technology Director, Pall Life Sciences/BioPharmaceuticals
New purification and recovery technologies 14:30 Reducing costs, increasing yield and improving purity of expressed proteins
· Improved separations technology for cost-effective high product purities
· The development of biomimetic affinity ligands
· Application of affinity chromatography to crude feed streams or to proteins
· Minimising the numbers of chromatographic steps in downstream processes
· Significant cost savings and yield improvements whilst maintaining or even improving product purity
Dr Oscar Reif, VP, Research & Development and Technology, Sartorius 15:00 Case study - orthogonal membrane technologies for viral and DNA clearance
· Viral clearance by size exclusion membrane filters
· DNA adsorption with membrane chromatography
· Orthogonal viral adsorption with membrane chromatography
· Process and regulatory implications
E.J. Brandreth, Favrille 15:30 Development of new affinity materials for use in the manufacture of biotherapeutics
· High-throughput techniques for rapid development of new affinity ligands
· Selective capture from biological source materials biocontaminant removal
· Impact on product recovery and cost of goods
Dr Steven Burton, VP, Research and Development, ProMetic BioSciences 16:00 Close of conference
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