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Lyophilisation Europe

SAE Media Group 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 SAE Media Group’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
 

FEATURED SPEAKERS

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

Conference agenda

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8:30

Registration & Coffee

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9:00

Session 1: Approaches to cycle development

  • Classic iterative approach
  • Alternative approaches including automated systems
  • Pros and Cons of each approach
  • Kevin Ward

    Kevin Ward, Director of R&D , BioPharma Technology

    Paul Matejtschuk

    Paul Matejtschuk, Principal Scientist, NIBSC

    clock

    9:30

    Session 2: Classic iterative approach

    • What information is needed prior to cycle development?
    • Integrating formulation design with cycle development
    • How can we maximise data generation from each run?
    • Practical tips for planning cycles and analysing the outcome

    Kevin Ward

    Kevin Ward, Director of R&D , BioPharma Technology

    Paul Matejtschuk

    Paul Matejtschuk, Principal Scientist, NIBSC

    clock

    10:30

    Morning Coffee

    clock

    11:00

    Session 3: Alternative approaches to cycle development

    • The use of software-based algorithms
    • Integrating QbD into the cycle development process

    Kevin Ward

    Kevin Ward, Director of R&D , BioPharma Technology

    Paul Matejtschuk

    Paul Matejtschuk, Principal Scientist, NIBSC

    clock

    11:30

    Session 4: Robustness testing and scale-up

    • Practical constraints of robustness testing
    • The use of DoE in robustness testing
    • Scale-Up factors, including differences in equipment, formulation and upstream processing parameters.

    Kevin Ward

    Kevin Ward, Director of R&D , BioPharma Technology

    Paul Matejtschuk

    Paul Matejtschuk, Principal Scientist, NIBSC

    clock

    12:20

    Networking Lunch

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Sune Andersen

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

    clock

    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
    clock

    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
    clock

    10:30

    Morning Coffee

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    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
    clock

    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

     

  • clock

    12:20

    Networking Lunch

    clock

    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
  • clock

    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
  • clock

    15:10

    Chairman’s Closing Remarks and Close of Day One

    clock

    8:30

    Registration & Coffee

    clock

    9:00

    Chairman's Opening Remarks

    Sune Andersen

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

    clock

    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
    clock

    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
  • clock

    10:30

    Morning Coffee

    clock

    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
    clock

    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
  • clock

    12:20

    Networking Lunch

    clock

    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
    clock

    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
  • clock

    15:10

    Chairman’s Closing Remarks and Close of Day Two

    clock

    15:20

    Afternoon Tea and Networking


    Associated Principal Scientist
    Merck & Co Inc
    Scientist
    GSK
    Scientist
    GSK
    Freeze dryer scientist
    GSK
    Head of Injection Manufacturing Site
    AMATSIGROUP
    Professor of Pharmaceutical Process Analytical Technology
    De Montfort University
    Founder
    RheaVita BV
    Director of R&D
    BioPharma Technology
    Principal Scientist
    NIBSC
    Senior Statistician
    Arlenda
    Principal Scientist Drying Processes
    Novo Nordisk A / S
    Professor and Head of PAT
    University Of Ghent

    Official Media Partner

    Official Publication

    Supporters

    Workshops

    Design and scale up of a freeze drying process

    Design and scale up of a freeze drying process

    Holiday Inn Kensington Forum
    6 July 2016
    London, United Kingdom

    Lyophilisation Europe: An Interview with Arlenda

    Download

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    The European Journal of Parenteral & Pharmaceutical Sciences

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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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