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The global market for lyophilisation is projected to be worth $3.26bn in 2015, spurred by the strong growth of new drugs and efforts to increase clinical approval. Lyophilization is an established method in the formulation of biological products, and an invaluable tool for prolonging shelf life and stability for biological drugs and vaccines.

As under met needs in drug transport and long term storage continues to prevail, robust lyophilization methods outlined in PAT and QbD principles as well as alternative technologies will continue to experience strong demand.

This conference will focus on the scale- up efforts in the pharmaceutical industry with key topics in:

• PAT
• Quality by Design
• Vaccines
• Biological drugs
• Spray drying
In addition, a panel discussion on both days will focus on sale up and engineering issues, highlight new areas of innovation and debate whether small scale results in the laboratory provide realistic results in commercial scale up.
 

This year’s event will feature spotlight presentations on:

  • Innovative engineering techniques for building a robust scale up system;
  • Implementation of PAT and QbD principles in industry and where it falls short
  • Applications in therapuetic areas including vaccines, biologics and monoclonal antibodies.

 Plus two panel discussions on both days for an engaging session between academia and pharma.

  • Understand how to impliment PAT and QbD to gain the maximum benefits
  • Discover the latest computational tools in use for predicting morphological changes during freeze drying
  • Join the panel debate on where scale up falls short and whether small scale studies represent are too idealistic?
  • Gain insight of some of the most important therapeutic drug classes using frezze drying technology and how they will perform in the next decade
   

Allembis Ltd; Antech Ltd; Bavarian Nordic A/S; Baxter AG; Biogenidec; Biolab Sanus Farmaceutica Ltda; CESPU; Chr. Hansen A/S; De Montfort University; Ellab Inc; Ellab UK Ltd.; Explicat Pharma GmbH; GEA Pharma Systems ; GEA Process Engineering; GEA Process Engineering A/S; GEA PROCESS ENGINEERING LTD; Genzyme Corporation; Genzyme Ireland Ltd in collaboration in University College Cork; GlaxoSmithKline plc; Hoffmann / La Roche; HOLOGIC LTD; Imperial College London; Ipsen; Ipsen Ltd; LFB Biotechnologies; Lohmann Animal Health Gmbh; Loughborough University; MedImmune; MedImmune Inc.; MedImmune Ltd; Newcastle University; NIBSC; Norgine; Novo Nordisk A / S; Pfizer; Politecnico Di Torino; SP Scientific; UCL Institute of Child Health; University College Cork; University Of Ghent; University Of Liverpool; University of Porto;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening remarks

Yves Mayeresse

Yves Mayeresse, Director primary and secondary Expertise, GlaxoSmithKline

9:10 Keynote address: Implementation of QbD in lyophilisation

Yves Mayeresse

Yves Mayeresse, Director primary and secondary Expertise, GlaxoSmithKline

  • Improving flexibility and robustness of the process design
  • Quantitative performance measures to ensure product quality
  • Identifying stabilising excipients to ensure drug stability
  •  Evaluating risk factor of material attributes
  • 9:50 The Basics of Freeze Drying

    Patrick  Garidel

    Patrick Garidel, Process Sciences Department, Head of Pharmaceutical Basic Development, Boehringer-Ingelheim

    10:30 Morning Coffee

    11:00 Considerations for scale up

    Michael Dekner

    Michael Dekner, Manager of Innovation, Baxter BioSciences

     

    ·          From lab to large scale
    ·          A generic approach to scale-up
    ·          Challenges of scale up

     

     
     

    11:40 Validation of the Lyophilisation process

    Marc Hayes

    Marc Hayes , Product Manager, Ellab UK Ltd.

    12:20 Networking Lunch

    13:20 Molecular dynamics simulations of freeze drying of protein therapeutics

    Mire  Zloh

    Mire Zloh, Head of Pharmaceutical Chemistry , University of Hertfordshire

     

     

           Lyophilisation of protein therapeutics

           Principles of molecular dynamics simulations

           Protocols for simulation of freeze drying process

           Case studies of freeze drying of protein therapeutics.

     

    14:00 Spray-drying process development and scale-up for complex dosage forms: an alternative to lyophilisation

    Eunice Costa

    Eunice Costa, Process Developement Engineer, Hovione Sociedade Quimica SA

     

     
    ·          Benchmarking lyophilisation with spray drying
    ·          Challenges in spray drying process and formulation development for complex dosage forms
    ·          Maintaining product critical quality attributes across scales        
    ·          Case study: Scale-up of spray dried formulations

    14:40 Round Table Discussion Session

    15:20 Crystal nucleation: Theory and Modelling

    Jamshed  Anwar

    Jamshed Anwar, Associate Dean for Research & Professor of Computational Chemistry, Lancaster University

     

    ·         Classical nucleation theory
    ·         Multi-step nucleation
    ·         Molecular simulation of crystal nucleation
    ·         Modulation of crystal nucleation using additives

    16:00 Afternoon Tea

    16:30 The mechanical properties of lyophilised cakes

    Daryl Williams

    Daryl Williams, Reader in Particle Science, Imperial College London

     

    ·          The properties of mechanical properties of lyophilised cakes are a potential QbD property
    ·          Discussion: The mechanical properties of protein-based lyophilized cakes

    17:10 Panel discussion

     

    ·          Review PAT and QbD principles and discuss current challenges facing scale up and quality control
    ·          Discuss opportunities for continuous lyophilisation
    ·          Identify ways to bridge the gap between commercial and laboratory lyophilisation
    Yves Mayeresse

    Yves Mayeresse, Director primary and secondary Expertise, GlaxoSmithKline

    Eunice Costa

    Eunice Costa, Process Developement Engineer, Hovione Sociedade Quimica SA

    Michael Dekner

    Michael Dekner, Manager of Innovation, Baxter BioSciences

    17:50 Chair's Closing Remarks and Close of Day One

    Yves Mayeresse

    Yves Mayeresse, Director primary and secondary Expertise, GlaxoSmithKline

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Sune Andersen

    Sune Andersen, Principal Scientist Drying Processes, Novo Nordisk A / S

    9:10 Opening Address: Scale up methodologies for spray drying processes

    Sune Andersen

    Sune Andersen, Principal Scientist Drying Processes, Novo Nordisk A / S

     

     
    ·          A viable alternative to achieving continuous production
    ·          Optimising solution/suspension properties to maintain critical quality attributes
    ·          Challenges with atomization
    ·          Case study: Spray drying of nanoparticles
     

    9:50 Utilising Freeze Drying Screening with translation to Spray Drying for novel Nanomedicines

    Steve Rannard

    Steve Rannard, Chair of Chemistry, Liverpool University

  • Utilising freeze drying for nanoparticle formation
  • Miniaturisation of emulsion freeze drying for screening
  • Translation to spray drying and nanomedicine clinical trials
  • 10:30 Morning Coffee

    11:00 The value of modelling in spray dried product development

    Andrew Bayly

    Andrew Bayly, Chair in Chemical Engineering, Institute of Particle Science and Engineering, Leeds University

     

    ·          Understanding process influence and scale
    ·          Predicting product structure and product quality
    ·          Efficient approaches with models and experiments

    11:40 Engineering Spotlight: Engineering a continuous process to ensure end product quality

    Bruce  Williams

    Bruce Williams , Chartered chemical and process engineer,, Williams Process

     

    ·          Controlling product structure and homogeneity during freezing
    ·          Process intensification and economic factors in scale up
    ·          Integration with upstream and downstream operations
    ·          Design for scalability and robust technology transfer.

    12:20 Networking Lunch

    13:20 Enabling technologies in lyophilisation processes

    Andrew Tait

    Andrew Tait, Postgraduate Research Engineer, Newcastle University

     

    ·          New approaches and robust technology  transfer
    ·          Recognising the need for and challenges of continuous production in industry
    ·          Case study

    14:00 KEYNOTE: Implimenting QbD tools to optimise product quality

    Pierre Lebrun

    Pierre Lebrun, Associate Statistician - Project Leader, Arlenda

     

     
    ·          Integrating risk-based approaches into QbD principles
    ·          Maintaining continuous process validation and control of process parameters.
    ·          Case study on material flow
     

    14:40 Round Table Discussion

    15:00 Afternoon Tea

    15:30 PAT on Pharmaceutical Processes

    Edith  Norrant

    Edith Norrant , Innovations Technology Sciences DirectorInnovations Technology Sciences Director, UCB Pharma

     

     

    ·          Optimising product shelf life for biological drugs
    ·          Establishing the correct safety margins to prevent temperature collapse
    ·          Batch process vs continuous process
    ·          Product imposed limitations vs operations –imposed limitations

     

    16:10 Panel discussion

     

    ·          Application of Quality-by-Design to process development
    o    Which steps are it most often applied to? Is it relevant to apply it to all steps?
    o    How often is it used in IMPDs/CTAs?
    o    Experience with filing equations?
    ·          Discuss the unique challenges facing design of experiments
    ·          Future prospects for continuous production processes
    ·          Critical issues and major cost drivers with technology transfer in scale up
    Andrew Tait

    Andrew Tait, Postgraduate Research Engineer, Newcastle University

    Bruce  Williams

    Bruce Williams , Chartered chemical and process engineer,, Williams Process

    Edith  Norrant

    Edith Norrant , Innovations Technology Sciences DirectorInnovations Technology Sciences Director, UCB Pharma

    16:50 Chair’s Closing Remarks and Close of Day Two

    Sune Andersen

    Sune Andersen, Principal Scientist Drying Processes, Novo Nordisk A / S

    +

    FEATURED SPEAKERS

    Eunice Costa

    Eunice Costa

    Process Developement Engineer, Hovione Sociedade Quimica SA
    Yves Mayeresse

    Yves Mayeresse

    Director primary and secondary Expertise, GlaxoSmithKline

    Andrew Bayly

    Chair in Chemical Engineering, Institute of Particle Science and Engineering, Leeds University
    Andrew Bayly

    Andrew Tait

    Postgraduate Research Engineer, Newcastle University
    Andrew Tait

    Bruce Williams

    Chartered chemical and process engineer,, Williams Process
    Bruce  Williams

    Daryl Williams

    Reader in Particle Science, Imperial College London
    Daryl Williams

    Daryl Williams

    Director, Imperial College London
    Daryl Williams

    Edith Norrant

    Innovations Technology Sciences DirectorInnovations Technology Sciences Director, UCB Pharma
    Edith  Norrant

    Eunice Costa

    Process Developement Engineer, Hovione Sociedade Quimica SA
    Eunice Costa

    Jamshed Anwar

    Associate Dean for Research & Professor of Computational Chemistry, Lancaster University
    Jamshed  Anwar

    Marc Hayes

    Product Manager, Ellab UK Ltd.
    Marc Hayes

    Michael Dekner

    Manager of Innovation, Baxter BioSciences
    Michael Dekner

    Mire Zloh

    Head of Pharmaceutical Chemistry , University of Hertfordshire
    Mire  Zloh

    Patrick Garidel

    Process Sciences Department, Head of Pharmaceutical Basic Development, Boehringer-Ingelheim
    Patrick  Garidel

    Pierre Lebrun

    Associate Statistician - Project Leader, Arlenda
    Pierre Lebrun

    Steve Rannard

    Chair of Chemistry, Liverpool University
    Steve Rannard

    Sune Andersen

    Principal Scientist Drying Processes, Novo Nordisk A / S
    Sune Andersen

    Yves Mayeresse

    Director primary and secondary Expertise, GlaxoSmithKline
    Yves Mayeresse

    Official Media Partner

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    Official Publication

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    Workshops

    Spray drying and Formulation
    Workshop

    Spray drying and Formulation

    Holiday Inn Regents Park
    1st July 2015
    London, United Kingdom

    Defining and Implementing QbD in the Design Space for Scale Up
    Workshop

    Defining and Implementing QbD in the Design Space for Scale Up

    Holiday Inn Regents Park
    1st July 2015
    London, United Kingdom

    An interview with Pierre Lebrun, an experienced Statistician and Project Leader from Arlenda

    Download

    Lyophilisation Europe Attendee List 2015

    Download

    An interview with iFormulate and University of Leeds – Spray Dry Formulation workshop leaders

    Download

    An interview with Sune Klint Andersen, Principle Scientist, Novo Nordisk

    Download

    An interview with Baxter Biosciences

    Download

    Interview on QbD in Lyophilisation with GSK

    Download

    QbD explained by Takeda Principle Scientist, Poul Bertelsen

    Download

    SMi presents it’s global Lyophilisation series for 2015

    Download

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    Contract-Biotechnology.com is a web-based platform for laboratory outsourcing solutions. We are an online R&D matching tool that connects Scientifics and organizations involved in discovery, development and delivery of new healthcare products with service and products providers worldwide. Life science information technology is undergoing a revolution. Part of that revolution involves new, unexplored business models, open innovation, open data and collaboration. If you have a project or idea that you would like to propose, develop or run, we can help. A New Collaboration Network Model for Discovery Research and Development • Effective Platform: the 95% • 5.000 registered users // > 15.000 Newsletter subscribers • Geographical background: 45,5% Europe / 37,5% North America / 16,5% Asia / 0,5% ROW • Professional background: Outsourcing Manager, Project Manager, CEO, Business Developer, CSO, Account Manager, Sales & Marketing People, Scientists, R&D. For further information, please visit our website www.contract-biotechnology.com


    Bioscreening

    Supporters
    http://www.bioscreening.com



    Pharma Technology Focus

    Supporters
    http://www.nridigital.com/

    Pharma Technology Focus Magazine is a dynamic bi-monthly online publication available on iPad and online. It offers in-depth coverage of the most important issues and the latest developments in the pharmaceutical industry, in an innovative digital format. Brought to you by an experienced editorial and design team, Pharma Technology Focus is the essential magazine for decision-makers wanting up-to-date pharmaceutical industry news and analysis, with articles and features covering technology, discovery and development, packaging and labelling, supply chains, manufacturing and ingredients, trials and successes and much more.

    Holiday Inn Regents Park

    Carburton Street
    London W1W 5EE
    United Kingdom

    Holiday Inn Regents Park

    Choose the well-connected Holiday Inn London-Regent's Park hotel, with a superb central London location and speedy transport links. Holiday Inn London-Regent's Park is in a leafy and cosmopolitan area of central London, a 10-minute walk from bustling Oxford Street. Leave your car in our NCP managed underground car park, and explore London by Tube. Great Portland Street Tube station is 25 metres from the hotel, from where you can reach the City and Canary Wharf in 30 minutes, and London Heathrow Airport in 45 minutes.

    Wireless Internet is available throughout the hotel, and you can invite up to 300 people to events at the Academy Conference Centre, with an IT technician and break-out zones. Holiday Inn London-Regent's Park is a 10-minute walk from Santander's offices and businesses in the BT Tower. Stroll 5 minutes to Regent's Park, where you'll find London Zoo and pretty Primrose Hill. We're a 10-minute walk from Bond Street boutiques and 20 minutes from Buckingham Palace and cruises on the River Thames.

    Ask our Concierge to plan your day out and book West End theatre tickets. Room Service is available 24 hours at Holiday Inn London-Regent's Park, or dine in the vibrant Junction Restaurant. Our Junction Bar has a menu of light bites, and a hot breakfast buffet is served daily.

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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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    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
    Registered in England No: 3779287 VAT No: GB 976 2951 71




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