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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
• PAT
• CMC
• 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

Daniela Stranges

Daniela Stranges, Senior 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 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
  • 11:40 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

    12:20 Networking Lunch

    13:30 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

     

  • 14:10 Optimisation of industrial freeze drying cycle - Two case studies

    Mostafa Nakach

    Mostafa Nakach, Head of Pharmaceutical Engineering Group, Sanofi-Aventis R&D

     

  • Redevelop a freeze drying process for internal manufacturing of two “old” products of the 60’s (called “A” and B”) performed with historical cycles
  • Methodology is based on the product knowledge, the equipment knowledge, modeling and simulation
  • Study outcomes: Validation batches with full rational leading to compliant product and Optimized productivity
  • 14:50 Afternoon Tea

    15:20 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
  • 16:00 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
  • 16:40 Panel discussion: Designing formulations for lyophilized products

    Jos Corver

    Jos Corver, Founder, RheaVita BV

  • Identify the right formulation
  • Characterizing the amorphous and crystalline structure of ice per individual vial in a cluster within the dryer
  • Correlating porous structure with rehydration kinetics to optimize drying processes
  • 17:20 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 Sponsor session: Establishing the correct safety margins to prevent temperature collapse

    11:40 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

    12:20 Networking Lunch

    13:30 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
  • 14:10 Freeze-Drying of highly concentrated biologics at specific formulation conditions

    Patrick Garidel

    Patrick Garidel, Head of Pharmaceutical Basic Development, Boehringer Ingelheim

  • Freeze drying of highly concentrated protein formulations
  • Buffer-free formulations
  • Impact on stability
  • Case study with a monoclonal antibody
  • 14:50 Afternoon Tea

    15:20 Modern process of lyophilisation

    Andrea Weiland

    Andrea Weiland, Pharmacist, Ph.D.Managing Director, Explicat Pharma GmbH

  • Evaluation of current lyophilisation approach
  • Real time PAT control
  • How to modernize your process

     

     

  • 16:00 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

    16:40 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Daniela Stranges

    Daniela Stranges

    Senior Scientist, GSK
    Mostafa Nakach

    Mostafa Nakach

    Head of Pharmaceutical Engineering Group, Sanofi-Aventis R&D
    Patrick Garidel

    Patrick Garidel

    Head of Pharmaceutical Basic Development, Boehringer Ingelheim
    Sune Andersen

    Sune Andersen

    Principal Scientist Drying Processes, Novo Nordisk A / S

    Andrea Weiland

    Pharmacist, Ph.D.Managing Director, Explicat Pharma GmbH
    Andrea Weiland

    Daniela Stranges

    Senior Scientist, GSK
    Daniela Stranges

    Donna Williams

    Associated Principal Scientist, Merck & Co Inc
    Donna Williams

    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

    Mostafa Nakach

    Head of Pharmaceutical Engineering Group, Sanofi-Aventis R&D
    Mostafa Nakach

    Patrick Garidel

    Head of Pharmaceutical Basic Development, Boehringer Ingelheim
    Patrick Garidel

    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

    Supporters

    Workshops

    Design and scale up of a freeze drying process
    Workshop

    Design and scale up of a freeze drying process

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

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    Holiday Inn Kensington Forum

    97 Cromwell Road , London, United Kingdom

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

    HOTEL BOOKING FORM

    Lyophilisation Europe: An Interview with Arlenda

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    Holiday Inn Kensington Forum

    97 Cromwell Road
    London SW7 4DN
    United Kingdom

    Holiday Inn Kensington Forum

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

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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.

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    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.

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    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 2nd Floor South, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, United Kingdom, Link to Map
    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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