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Biopharmaceuticals are a growing area for biotechs and pharmaceutical companies.  With this market expanding rapidly with the aquisition of the top biotechs by pharma, there has never been a better time to look at maximising the success of this area.

SMi's inaugural Biological Production conference looks to address the main areas of the production of biological products, process scale-up and validation, comparability issues and technology transfer, with a series of case studies from industry leaders.  Hear methods for the development of an integrated approach to your mammalian cell line development from Pfizer, the utilisation of scale process models in your process scale-up from BTG and the importance of communication in technology transfer from Novartis.

 With large pharma, biotechs and CMO's all getting together to discuss the challenges they face in their production of biological products, don't miss an opportunity to learn from their experience at this conference.

This conference is not to be missed by those working in the manufacture of biological products:

  • Process Development
  • Process Validation
  • Cell Line Development
  • Process Science
  • Biotherapeutics

This conference is not to be missed by those working in the manufacture of biological products:

  • Process Development
  • Process Validation
  • Cell Line Development
  • Process Science
  • Biotherapeutics

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Stephen Taylor

Stephen Taylor, Director, Avecia Biologics

9:10 OVERVIEW

Stephen Taylor

Stephen Taylor, Director, Avecia Biologics

  • The current market for biologicals
  • The invasion of large Pharma into the biotech arena
  • The expected impact of the current economic climate
  • Growth in the far east
  • 9:50 CASE STUDY: STRATEGIC OUTSOURCING

    Arindam Bose

    Arindam Bose, Executive Director of Biologics Strategy & Alliances, Worldwide Pharmaceutical Sciences, Pfizer

  • Pfizer's biotech product portfolio: how did we get here?
  • Outsourcing of product development activities: drivers & current status
  • Operational excellence in outsourcing
  • Implications of technology advancements
  • Considerations for outsourcing to Asia
  • 10:30 Morning Coffee

    11:00 COMPARING IMMUNOGENICITY IN BIOLOGICALS

    Robin Thorpe

    Robin Thorpe, Head, Biotherapeutics Group, National Institute For Biological Standards And Control

  • Techniques for the comparison of immunogenicity
  • The issue of unwanted immunogenicity
  • Relating this to biosimilars
  • 11:40 DEVELOPING PRODUCTION PLATFORMS FOR A PORTFOLIO APPROACH

    E. Morrey Atkinson

    E. Morrey Atkinson, Director, Bioprocess R&D, Eli Lilly & Company

  • A case study in the US and Ireland Processes must be inherently robust to facilitate technology transfer
  • Recent examples of the integration of multiple groups with a common goal
  • Challenges and accomplishments of deliberately limiting options while maximising the probability of success
  • 12:20 Networking Lunch

    13:50 FROM BASIC BIOSCIENCE TO LARGE-SCALE PRODUCTION

    Chris Hewitt

    Chris Hewitt, Professor of Pharmaceutical Engineering, Loughborough University

  • Most bioscientists don't have a scaleable process
  • Scale-up is governed by a number of engineering principles and isn't simply making 'the pot bigger'
  • Detrimental changes in the bioprocessing often occur as we move up through the scales
  • These changes can be predicted by carrying out small scale simulations of the large scale
  • 14:30 CASE STUDY: AN INTEGRATED APPROACH TO MAMMALIAN CELL LINE DEVELOPMENT

    John Mott

    John Mott, Director, Bioprocess R&D, Cell Line Development, Global Biologics, Pfizer

  • Number of monoclonal antibodies entering development has increased
  • Expectations for shortening development timelines has also increased
  • An integrated approach to cell line enrichment and screening that has enabled the selection of high producing cell lines
  • Approach includes medium development, automation and use of technologies that support the rapid selection of clinical and commercial cell lines
  • 15:10 Afternoon Tea

    15:40 PROCESS DESIGN: FROM DRUG DISCOVERY TO MARKETING AUTHORIZATION

    David Glover

    David Glover, Senior Director, BioProcess R&D, UCB Celltech

  • Selecting antibody candidates fit for manufacturing
  • Choosing and developing the manufacturing platform
  • Integrating upstream and downstream processing
  • Implementing appropriate control strategies based on product and process understanding
  • Discussing effective regulatory strategies
  • 16:20 UTILIZATION OF SCALE PROCESS MODELS, REALITY AND EXPERIENCE

    Richard Francis

    Richard Francis, Director Process Science, BTG

  • Overview of the utility of small scale process models for definition of process parameters and mapping out the design space
  • Case studies relating to the utilization of small scale process models and understanding the limitations
  • Linking the use of small scale models with the rest of the process development toolkit facilitation process modification, transfer and PAT
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Bernard Chan

    Bernard Chan, Chief Business Officer, CMC Biologics

    9:10 DRIVING BIOPROCESS INNOVATION THROUGH KNOWLEDGE TRANSFER

    Mark Bustard

    Mark Bustard, Head of bioProcessUK, HealthTech & Medicines KTN

  • Putting knowledge into practice
  • Strategies for effective knowledge transfer
  • Skills linkage to bioprocessing innovation
  • 9:50 CASE STUDY: COMMUNICATION IN TRANSFER

    Jens Lohrmann

    Jens Lohrmann, Principal Scientist, Analytical R&D, Novartis Biologics

  • Potential pitfalls
  • Lessons learned
  • The importance of effective communication
  • 10:30 Morning Coffee

    11:00 DEALING WITH CMOS

    Bernard Chan

    Bernard Chan, Chief Business Officer, CMC Biologics

  • Technical and regulatory requirements for different scales at multipurpose sites
  • Risk management and assessment of CMO's
  • Challenges when outsourcing to CMO's
  • 11:40 GLYCOSYLATION OF PROTEIN THERAPEUTICS

    Roy Jefferis

    Roy Jefferis, Professor of Molecular Immunology, School of Immunity & Infection, University Of Birmingham

  • Complexity of biopharmaceutical glycosylation
  • Post Translational Modifications
  • Problems, solutions and opportunities
  • 12:20 Networking Lunch

    13:50 APPLYING ENHANCED QBD APPROACH FOR THE MANUFACTURE OF MAMMALIAN CELL-DERIVED RECOMBINANT PROTEINS

    Herve Broly

    Herve Broly, Vice President of Center of Expertise Manufacturing and Head of Biotech Process Sciences, Merck Serono

  • How biopharmaceutical glycosylation affects product safety and efficacy
  • Enhancing your QbD approach
  • Case study: manufacture of mammalian call-derived recombinant proteins
  • 14:30 QbD APPROACH

    Daryl Fernandes

    Daryl Fernandes, CEO, Ludger

  • ICH Q6B and Q5E guidelines and glycosylation
  • A well-designed QbD approach can save time and money in drug development and production
  • Principles of a QbD framework
  • 15:10 Chairman’s Closing Remarks

    15:15 Afternoon Tea and Close of Conference

    +

    Workshops

    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    HOTEL BOOKING FORM

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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