SMi is proud to announce the return of the 4th annual Lyophilisation-Europe conference 2016 in London!

Lyophilisation is used by the pharmaceutical industry for years. Recently, more than 30% of parenteral Food and Drug Administration (FDA) approvals were for lyophilised drugs, and estimates predict that soon more than half of all injectable drugs will require lyophilisation. While a lot of R&D efforts have been input in freeze drying process with actual advancements, the process incurs huge costs and is very complex.
Join us at SMi’s 4th annual Lyophilisation-Europe Conference taking place on the 4th-5th July 2016 in London.

This event will explore QbD and the regulatory affairs, lyophilisation related topics such as with high concentration protein formulation, new techniques of freeze dryers and many more!

A series of practical case studies, interactive roundtables and panel discussion facilitated by leading industry experts will provide executives with useful tools and best practices to:
• Controlling the impact of process variables and managing risk
• Ensure product quality
• Implement a robust lyophilisation process
• Optimise spray drying process and formulation development for complex dosage forms
• Optimise freeze drying process
• Challenges in spray drying process and formulation development for complex dosage forms
• Integrating risk-based approaches into QbD principles

VPs, Directors, Chiefs, Heads, Principals, Managers, Scientists and Analysts of:

• Lyophilisation
• Formulation Scientist
• Bioprocessing
• Process Development
• Sterile/ Fill-Finish
• Production
• Chemistry
• Manufacturing
• Quality Assurance/QA
• Freeze-Drying

Arlenda; ATG Scientific Ltd; Baxalta; Baxter A G; Biopharma Technology LLC; Boehringer-Ingelheim; Celgene; CPES, University of Bradford; Ellab UK Ltd.; GEA Lyophil GmbH; GEA PROCESS ENGINEERING LTD; GlaxoSmithKline Biologicals; Hovione Sociedade Quimica SA; Imperial College London; Institute for Translational Vaccinology; Lancaster University; Leeds University; LFB Biotechnology; Liverpool University; Merck Sharp & Dohme Limited; Newcastle University; Novo Nordisk A / S; Peptisyntha; Pierre Fabre Medicaments; ROCHE DIAGNOSTICS GMBH; Sanofi; School of Pharmacy, De Montfort University; Ucb Pharma Belgium; Univeristy Of Liverpool; University College London Medical School; University of Hertfordshire; University Of Liverpool; UQUIFA, S.A.; West Pharmaceutical Services Deutschland GmbH & Co KG; Williams Process ;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Sune Andersen

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

9:10 Application of QbD principles to design lyophilisation process robustness studies in support tech transfer of a freeze-dried vaccine component

Emanuele Tomba

Emanuele Tomba, Scientist, GSK


·          Introduction: General overview of QbD principles and tools applied to vaccines development
·          Case study is related to combination vaccine in which one component is a freeze-dried product
in order to confirm process parameters set points and define PAR for lyophilisation step the following approach has been pursued: Definition of QTPP and product CQAs for lyophilisation process step: Risk assessment performed to determine possible interaction between PPs and product CQAs;
·          Set up of down scale model representative of manufacturing scale; experimental plan design: Results analysis for identification of Proven Acceptable Ranges for CPPs
·          Manufacturing control strategy confirmed through execution of confirmatory runs

9:50 Constructing a robust design space based on product and process limitations

Kevin Ward

Kevin Ward, Director of R&D , BioPharma Technology


·         The basics of constructing and using a Design Space using Prior Knowledge and experimental data
·         The balance between desktop research and practical studies
·         Finding more quantitative aspects of lyophile analysis to include in QbD – structural and mechanical properties

10:30 Morning Coffee

11:00 Freeze-drying protein and vaccine formulations

Paul Matejtschuk

Paul Matejtschuk, Principal Scientist, NIBSC


·          Formulation development approaches
·          Impact of formulation on freeze drying cycle
·          Forced degradation to support long term storage

11:40 Through vial impedance spectroscopy : A process analytical technology (PAT) to develop a rational lyophilization cycle

Geoff Smith

Geoff Smith, Professor of Pharmaceutical Process Analytical Technology , De Montfort University

  • What are the challenges inherent to the preformulation and phases transitions during lyophilisations ?
  • What should be classed as critical process parameters ?
  • What happens on microscale-down and scale up ?
  • Developing the toolbox-overlapping (multiplexed) PAT from single vial to batch monitoring


  • 12:20 Networking Lunch

    13:30 Continuous freeze drying of (Bio-) pharmaceuticals

    Jos Corver

    Jos Corver, Founder, RheaVita BV

  • PAT - latest development
  • Fundamentals of system design
  • Challenges with continuous freeze drying and how to overcome
  • 14:10 Application of Statistics across the Lyo Product Lifecycle

    Perceval Sondag

    Perceval Sondag, Senior Statistician, Arlenda

  • Statistics for Quality-by-Design (QbD)
  • Optimal sampling and capability prediction for process performance qualification (PPQ)
  • Predicting performance from bioreactor to the patient
  • 15:10 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Sune Andersen

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

    9:10 Challenges in spray drying process and formulation development

    Sune Andersen

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


    ·         Benchmarking lyophilisation with spray drying’
    ·         A viable alternative for achieving continuous production
    ·         Maintaining product critical quality attributes across scales

    9:50 ATEX regulation applied to a manufacturing workshop of high potent injectables

    Franck Pavan

    Franck Pavan, Head of Injection Manufacturing Site, AMATSIGROUP

  • The ATEX regulation
  • Process review
  • Validation activities
  • 10:30 Morning Coffee

    11:00 On the use of PAT tools and statistical analysis to determine optimal freeze drying cycle parameters for scale-up

    Erwan Bourles

    Erwan Bourles, Freeze dryer scientist, GSK


    ·         Design of experiment approach in order to select the accurate process parameters to preserve product from collapse
    ·         Surface response analysis to create a process acceptable range for the selected freeze drying cycle
    ·         Validation of the process acceptable range with experimental trials using PAT tools

    11:40 Panel discussion: Challenges of optimising filling processes and maintaining freeze dryers

    Erwan Bourles

    Erwan Bourles, Freeze dryer scientist, GSK

  • Design of experiment in order to select the accurate process parameters to preserve product from collapse
  • Surface response analysis to create a process acceptable range for the selected freeze drying cycle
  • Validation of the process acceptable range with experimental trials using PAT tools
  • 12:20 Networking Lunch

    13:30 Uncertainty and global sensitivity analysis (GSA) for the (dynamic) design space determination of a traditional and continuous freeze-drying process

    Thomas  De Beer

    Thomas De Beer, Professor and Head of PAT, University Of Ghent


    ·         Dynamic design space determination
    ·         Process modelling & simulation
    ·         Uncertainty and global sensitivity analysis

    14:10 Formulation and drying strategies for stabilising biologics and vaccines

    Donna Williams

    Donna Williams , Associated Principal Scientist, Merck & Co Inc

  • Strategies for improving thermostability
  • Rapid formulation screening
  • Optimising lyophilisation cycle
  • 15:10 Chairman’s Closing Remarks and Close of Day Two

    15:20 Afternoon Tea and Networking



    Sune Andersen

    Sune Andersen

    Principal Scientist Drying Processes, Novo Nordisk A / S

    Donna Williams

    Associated Principal Scientist, Merck & Co Inc
    Donna Williams

    Emanuele Tomba

    Scientist, GSK
    Emanuele Tomba

    Emanuele Tomba

    Scientist, GSK
    Emanuele Tomba

    Erwan Bourles

    Freeze dryer scientist, GSK
    Erwan Bourles

    Franck Pavan

    Head of Injection Manufacturing Site, AMATSIGROUP
    Franck Pavan

    Geoff Smith

    Professor of Pharmaceutical Process Analytical Technology , De Montfort University
    Geoff Smith

    Jos Corver

    Founder, RheaVita BV
    Jos Corver

    Kevin Ward

    Director of R&D , BioPharma Technology
    Kevin Ward

    Paul Matejtschuk

    Principal Scientist, NIBSC
    Paul Matejtschuk

    Perceval Sondag

    Senior Statistician, Arlenda
    Perceval Sondag

    Sune Andersen

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

    Thomas De Beer

    Professor and Head of PAT, University Of Ghent
    Thomas  De Beer

    Official Media Partner

    Official Publication



    Design and scale up of a freeze drying process

    Design and scale up of a freeze drying process

    Holiday Inn Kensington Forum
    6th July 2016
    London, United Kingdom

    Lyophilisation Europe: An Interview with Arlenda


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    The European Journal of Parenteral & Pharmaceutical Sciences is the official quarterly journal of the Pharmaceutical and Healthcare Sciences Society (PHSS). The journal provides an international forum for publishing original papers, editorials and reviews on subjects that cover all aspects of the pharmaceutical and healthcare sciences, both practical and scientific, including: lyophilisation, isolator technology, packaging, biotechnology, sterilisation techniques, aseptic processing, LAL testing and preservatives. If you wish to join The Pharmaceutical and Healthcare Sciences Society, or obtain information please visit the website or Email publisher@euromedcommunications.com | Tel +44 (0)14288 752 222

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    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.


    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.


    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.


    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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