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The world-wide demand for innovative protein therapeutics is growing each year. The manufacturing industry for bulk protein production, is constantly faced with challenges and complications that delay the delivery of protein therapeutics to market. Disruptions to any part of the development process have both a time consuming and costly impact on the therapeutic production cycle.

Protein Therapeutics: New Developments in Manufacturing & Production will explore recent developments in protein manufacturing and production, including the impact of new expression technologies on the protein production process, and how these technologies may be utilised to reduce costs and improve yields. The conference will also provide you with key information about how biotechnology is bringing protein drugs to market. Senior executives will present strategies to improve the bio-availability and efficacy of protein drugs, and evaluate the key issues in choosing protein expression systems for bulk production.

Why should you attend this event? This comprehensive conference is organised and produced by SMi: we have identified protein manufacturing as a targeted sector for executives anxious to keep a close eye on industry development. As a key industry representative, you are aware of the need to keep updated on developments that will increase both your efficiency and productivity. SMi conferences are leading-edge business events offering delegates the opportunity to meet senior industry and government figures and seek their advice and opinions. The conference will of course also be an ideal opportunity for you to network with a focused and appropriate audience.

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Dr Roger Lias

Dr Roger Lias, Vice President, Business Development, Covance Biotechnology

9:10 EVOLUTION OF THE BIOPHARMA MARKET

Dr Patrick Gage

Dr Patrick Gage, President, Wyeth-Ayerst Research

  • The current and changing biopharma
  • Is ‘blockbuster’ status an imperative for success?
  • Recombinant proteins: proving their value
  • Importance of the protein discovery/development platform
  • Developing and manufacturing recombinant proteins: the importance of integration
  • 9:40 ADVANCES IN PROTEIN THERAPEUTICS

    Dr Roger Lias

    Dr Roger Lias, Vice President, Business Development, Covance Biotechnology

  • The development and commercialisation of protein drugs
  • Strategies for optimising protein therapeutic agents
  • Advances in protein purification, analytical characterisation and formulation
  • Exploring new methods of protein delivery
  • The future of protein manufacture and delivery
  • Protein therapeutics: the next generation
  • 10:20 THE BENEFITS OF PROTEIN CRYSTALLISATION IN BIOMANUFACTURE

    Dr Alastair Paton

    Dr Alastair Paton, Vice President, Business Development, Europe, Altus Biologics

  • Uses of Crystallisation: i) Concentration ii) Stabilisation iii) Streamlining Process Steps iv) Formulation
  • Analytics employed
  • Novel uses e.g. Intact Monoclonal Antibodies
  • How a programme would work.
  • 11:00 Morning Coffee

    11:20 ALTERNATIVE PROTEIN PRODUCTION TECHNOLOGY

    Dr Dennis Vaccaro

    Dr Dennis Vaccaro, President and Chief Executive Officer, Symbiontics

  • Reasons for utilising alternative systems
  • Why use symbiotic organisms?
  • What are the advantages?
  • Symbiotic microbes: protein production of the future?
  • Potential use for high level protein production
  • Applying symbiotics to improve drug development
  • 12:00 DESIGNER PROTEIN THERAPEUTICS PLATFORMS

    Dr Kevin Bailey

    Dr Kevin Bailey, Vice President, Pre-Clinical Manufacturing and Process Development, Regeneron

  • What are designer protein therapeutics?
  • Benefits and therapeutic applications of designer proteins
  • Engineering product candidates with the desired properties
  • Challenges in the development of designer protein therapeutics
  • Case studies in design and development of proteins for clinical use
  • Future opportunities for designer proteins in the post-genomic age
  • 12:40 Networking Lunch

    13:40 YEAST PRODUCTION TECHNOLOGY

    Dr Philip Barr

    Dr Philip Barr, Presidentand Chief Operating Officer, Arriva Pharmaceuticals

  • Production of alpha 1-antitrypsin (AAT) in yeast
  • Glycosylation and pharmacokinetics
  • Production scale requirements
  • Yeast as a host system for serpins and other protease inhibitors
  • The future of yeast: secretion and intracellular systems
  • 14:20 USING ARTIFICIAL CHROMOSOMES TO PRODUCE NOVEL PROTEIN THERAPEUTICS

    Dr Joseph Zendegui

    Dr Joseph Zendegui, Vice President, Business Development, Chromos Molecular Systems

  • What is ACes Technology?
  • Advantages of artificial chromosome expression systems
  • Applying technology to increase yields and improve quality
  • Developing the future of protein-based therapies
  • 15:00 COMBINING PROTEIN EXPRESSION AND DIRECTED EVOLUTION

    Dr Dorsey Stuart

    Dr Dorsey Stuart, President and Chief Executive Officer, Neugenesis

  • Directed evolution: why one size doesn’t fit all
  • Reasons for utilising in situ systems
  • The unique position of Neurospora in this arena
  • What are the benefits: quality, quantity and economics?
  • Example of an improved enzyme
  • Application of high throughput screening to the system
  • 15:40 Afternoon Tea

    16:00 OPTIMISING THE PROTEIN DEVELOPMENT PROCESS

    Dr Raymon Sloan

    Dr Raymon Sloan, Head of Bioprocessing, Bradford Particle Design

  • What are the requirements for the development of highly-specified pharmaceuticals
  • Improving drug delivery for small molecules
  • Particle formation technology – lyophilisation, spray drying
  • SEDSTM process – a new technology
  • SEDSTM – an alternative for small and macro-molecules
  • SEDSTM – preparing protein drugs in a simple reproducible way

    SEDSTM – scale up to GMP

  • 16:30 THE LIFE-SAVING CHICKEN

    Anthony Cruz

    Anthony Cruz, Vice President, Corporate Development, AviGenics

  • Developing avian transgenesis technology
  • Utilising avian transgenesis technology: the advantages of putting all your eggs in one basket
  • How to harvest the gold
  • What are the benefits of harvesting protein from eggs?
  • Cutting costs and improving medicines
  • Golden eggs: the key to the future of protein medicine
  • 17:00 RECOMBINANT PROTEINS FROM TRANSGENIC PLANTS

    Dr Brandon Price

    Dr Brandon Price, President, Goodwin Biotechnology

  • Opportunities for large-scale protein production in agricultural systems
  • Transforming plants to produce antibodies and vaccines
  • Seed-based vs tissue-based systems
  • Manufacturing issues: producing therapeutic proteins using plant technology
  • The emerging regulatory environment
  • The future use of plant systems
  • 17:30 Chairman's Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Dr Ulrich Steiner

    Dr Ulrich Steiner, Project Manager, Bayer Biotechnology

    9:10 GLOBAL PHARMACEUTICAL MANUFACTURING STRATEGIES FOR PROTEIN THERAPEUTICS

    Dr Steven Burton

    Dr Steven Burton, Vice President, Research and Development, ProMetic Biosciences

  • Key issues facing the protein manufacturing industry
  • Protein processing, purification and manufacture
  • Benefits of using selective separations technology
  • Strategic options for protein production
  • Improving product purity
  • The shape of things to come
  • 9:40 NEW INNOVATIONS IN PROCESS TECHNOLOGY

    Dr Richard Francis

    Dr Richard Francis, Head of Purification & Development, Biopharmaceutical Process Services, GlaxoSmithkline

  • The production capacity demand: are you coping with the burden?
  • Will new technologies ease the burden?
  • Novel expression systems
  • Maximising output from cell bioreactor processes
  • Will the use of transgenics enhance protein therapeutic production?
  • GMP: the regulatory implications for new technologies
  • 10:20 MANUFACTURING THERAPEUTICS IN THE GLOBAL PHARMACEUTICAL INDUSTRY

    Dr Kate McCormick

    Dr Kate McCormick, Director, Pharmaceutical Consultancy, Heathside Information Services

  • Development and implementation of a good manufacturing strategy
  • Scaling up: practical issues
  • The making of medicine: development and delivery
  • Benefits and limitations of different manufacturing strategies
  • GMP: the way forward?
  • Increasing productivity without compromise
  • 11:00 Morning Coffee

    11:20 ENHANCING PRODUCTION CAPACITY OF THERAPEUTIC GLYCOPROTEINS BY GAINING CONTROL OVER GLYCOSYLATION

    Victor Sarantschin

    Victor Sarantschin, Director of Technical Marketing and Business Development, Neose Technologies

    12:00 PROTEIN ENGINEERING TECHNOLOGY FOR LARGE-SCALE MANUFACTURING

    Dee Athwal

    Dee Athwal, Senior Principal Scientist, Celltech

  • Knowledge based antibody engineering
  • Expression systems
  • Engineering antibodies for expression
  • Therapeutic design
  • Microbial Expression and purification of antibody fragments
  • Clinical results with antibody fragments
  • 12:40 Networking Lunch

    13:40 REGULATING THE DEVELOPMENT PROCESS

    Sam Brooks

    Sam Brooks, Principal Consultant, ABB Eutech

  • Regulatory interest in emerging products
  • Issues of automation and regulation
  • Industry response: cost of compliance vs benefits of quality
  • A validation example: research laboratory systems
  • A validation example: clinical protocol management
  • Enabling better business through validation technology
  • 14:20 ECONOMIC ISSUES IN PROTEIN MANUFACTURING

    Dr Robert Kuhn

    Dr Robert Kuhn, Associate Director, Process Development, Amgen

  • What are the challenges faced?
  • Key economic factors
  • Impact of molecule selection and production system
  • Process optimisation strategies and impact of new technologies
  • The impact of plant capacity on cost of production
  • Manufacturing for profitability
  • 15:00 STRATEGIC ISSUES IN THE PROTEIN MANUFACTURING PROCESS

    Dr Louise Duffy

    Dr Louise Duffy, Director, Biopharmaceutical Technologies, GlaxoSmithkline

  • What are the current issues in the manufacturing arena?
  • The move from development to production: strategic alignment
  • Product comparability
  • Long-term plans: the economic challenge
  • The position for protein manufacturing in the future
  • 15:40 Afternoon Tea

    16:00 MONITORING THE MANUFACTURING PROCESS

    Dr Jeffrey Bockman

    Dr Jeffrey Bockman, Vice President, Defined Healthcare Research

  • Producing a protein product of consistent quality: challenges & obstacles
  • Assessing & identifying the appropriate analytical techniques
  • Assessing & identifying the appropriate molecular techniques for recombinant proteins
  • Assessing & identifying the appropriate biosafety techniques
  • Implementation: regulations and guidelines
  • 16:30 IMPROVING THE GLOBAL LICENSING & REGULATION PROCESS

    Dr Anne-Marie Georges

    Dr Anne-Marie Georges, Director, Regulatory Affairs, Legal and Information, GlaxoSmithkline Biologicals

  • Regulatory specificity for recombinant protein products - licensing procedure - scientific advice - challenges to the manufacturing process - clinical trials authorisation - GMP
  • Specific EU guidelines and data requirements
  • Need for global standardisation and harmonisation and ICH progress
  • Future regulatory environment
  • 17:00 Chairman's Closing Remarks and Close of Conference

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    Workshops

    The Modular Concept: Improving your manufacturing strategy
    Workshop

    The Modular Concept: Improving your manufacturing strategy

    The Hatton, at etc. venues
    11th September 2001
    London, United Kingdom

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

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