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Lyophilisation: Freeze-Drying in Pharmaceuticals and Biopharmaceuticals
25 February - 26 February 2013
Lyophilisation: Freeze-Drying in Pharmaceuticals and Biopharmaceuticals

 

Lyophilisation has snow-balled over the years to create a massive number of techniques and technologies that increase the efficiency, stability and cost-effectiveness of the lyophilisation process, and every year brings new technologies and new techniques to combat the issues with the industry and enhance our existing solutions.

 

With SAE Media Group’s first event in this sector we will be bringing KOL's from the industry together to speak on the latest topics of Up Scaling, parameters in stabilisation, emerging technologies in freezing and monitoring techniques. We predict this to be a highly successful conference, and we would be delighted if you would join us in our new and exciting event.
 

FEATURED SPEAKERS

Jean Rene Authelin

Jean Rene Authelin

Global Head of Pharmaceutical Engineering, Sanofi-Aventis
Patrick Garidel

Patrick Garidel

Head of Pharmaceutical Basic Development, Boehringer Ingelheim Corporation
Paul Matejtschuk

Paul Matejtschuk

Principal Scientist, National Institute For Biological Standards & Control
Robert Johnson

Robert Johnson

Principal Scientist BioTherapeutics R&D, Pfizer
Sajal  Patel

Sajal Patel

Scientist II, MedImmune

Ahmad Abdul-Fattah

Scientist, Formulation and Process Development, Roche Pharmaceuticals
Ahmad Abdul-Fattah

Andrea Weiland-Waibel

Owner, Explicat Pharma GmbH
Andrea  Weiland-Waibel

Andrew Ingham

Lecturer, Pharmaceutics and Drug Delivery, Aston University
Andrew  Ingham

Edmond Ekenlebie

PhD Research Student, Aston University
Edmond  Ekenlebie

Haifei Zhang

RCUK Academic Fellow, University Of Liverpool
Haifei  Zhang

James Drinkwater

Chairman, Pharmaceutical and Healthcare Sciences Society
James  Drinkwater

Jean Rene Authelin

Global Head of Pharmaceutical Engineering, Sanofi-Aventis
Jean Rene Authelin

Jean-Pierre Amorij

Program Manager Vaccine Technology, National Institute for Public Health and the Environment
Jean-Pierre  Amorij

Kelvin Brockbank

Adjunct Associate Professor, Microbiology and Immunology , University Of Tuebingen
Kelvin  Brockbank

Larry Ulfik

President, Applewood Scientific
Larry  Ulfik

Patrick Garidel

Head of Pharmaceutical Basic Development, Boehringer Ingelheim Corporation
Patrick Garidel

Paul Matejtschuk

Principal Scientist, National Institute For Biological Standards & Control
Paul Matejtschuk

Per Wessman

Formulation Scientist, Agresearch
Per  Wessman

Robert Johnson

Principal Scientist BioTherapeutics R&D, Pfizer
Robert Johnson

Sajal Patel

Scientist II, MedImmune
Sajal  Patel

Sigrid Pieters

PhD, Vrije Universiteit Brussel
Sigrid Pieters

Stephanie Passot

Head of Food Process Engineering and Microbiology, INRA
Stephanie  Passot

Sune Andersen

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

Wouter Hinrichs

Assistant Professor Pharmaceutical Technology and Biopharmacy, University Of Groningen
Wouter Hinrichs

Yves Mayeresse

Director of Manufacturing, GSK Biologicals
Yves Mayeresse

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Patrick Garidel

Patrick Garidel, Head of Pharmaceutical Basic Development, Boehringer Ingelheim Corporation

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9:10

Residual moisture and the stability of freeze dried biologicals

Paul Matejtschuk

Paul Matejtschuk, Principal Scientist, National Institute For Biological Standards & Control

  • What do we mean by residual water and how is it measured?
  • Impact of residual moisture on stability of biologicals
  • Non invasive moisture analysis methods
  • Impact of cycle design and container format on residual moisture
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    9:50

    Conventional and unconventional approaches to develop lyophilized market formulations – what works and what doesn’t

    Ahmad Abdul-Fattah

    Ahmad Abdul-Fattah , Scientist, Formulation and Process Development, Roche Pharmaceuticals

  • Platform formulation approach for platform molecules
  • When the need to think outside of the box (i.e. non platform approaches): early signals
  • Alternate approaches to develop lyophilized marketed formulations for biologicals at high concentration – case studies
  • Alternate approaches to develop lyophilized marketed formulations for biologicals that do not fit the “platform” profile  – case studies
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    10:30

    Morning Coffee

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    11:00

    To collapse or not to collapse: Impact on product quality of freeze-dried biologics

    Patrick Garidel

    Patrick Garidel, Head of Pharmaceutical Basic Development, Boehringer Ingelheim Corporation

  • What is collapse and how can it be investigated?
  • Relation between the freeze drying process and product collapse
  • Impact of collapse on product quality
  • Case studies for biologics
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    11:40

    The pros and cons of aggressive freeze-drying of protein biologics

    Robert Johnson

    Robert Johnson, Principal Scientist BioTherapeutics R&D, Pfizer

  • Background --  crystalline vs amorphous cakes; high vs low protein concentrations; freeze concentration; glass-rubber transition temperature
  • What is collapse?  viscous flow of sucrose vs protein solutions; microcollapse vs macrocollapse; no adverse effect of collapse except prolonged secondary drying
  • What is aggressive freeze-drying?  why does it work so well?  Relief of tortuous path
  • Advantages – saving from cycle time reduction, simplicity – one cycle fits all, supercooling control and annealing not needed
  • Disadvantages & cautions – choke flow, dual-chambered syringes, cannot switch from conservative to aggressive during primary drying
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    12:20

    Networking Lunch

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    13:30

    Drying methods for vaccine design

    Jean-Pierre  Amorij

    Jean-Pierre Amorij, Program Manager Vaccine Technology, National Institute for Public Health and the Environment

  • Formulation design and drying methods for vaccine design towards QbD
  • Formulation and Lyophilization of Vaccines
  • Vaccine types and the need for a lyophilized formulation
  • Dried vaccine formulations to facilitate vaccine delivery
  • Choice of formulation and drying method
  • Use of DoE, PAT and how to implicate QbD
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    14:10

    Formulation for stabilisation of freeze dried bacterial cells

    Per  Wessman

    Per Wessman, Formulation Scientist, Agresearch

  • Freeze drying of microorganisms – an overview
  • Effects of dehydration on bacterial cells
  • Influence of formulation excipients on cell survival during freeze drying
  • Influence of formulation excipients on cell survival during storage of freeze dried material
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    14:50

    Afternoon Tea

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    15:20

    An evaluation of the advantages and disadvantages of controlling ice nucleation in the lyophilisation process

    Stephanie  Passot

    Stephanie Passot, Head of Food Process Engineering and Microbiology, INRA

  • Understanding of the physical chemistry of freezing
  • Why controlling ice nucleation is important
  • Different techniques to control ice nucleation
  • Benefits / Drawbacks

     

  • clock

    16:00

    Poorly water-soluble drug nanoparticles via a freeze-drying or solvent evaporation approach

    Haifei  Zhang

    Haifei Zhang, RCUK Academic Fellow, University Of Liverpool

  • Freeze-drying: a versatile route for porous materials
  • Drug nanoparticles by emulsion-freeze-drying
  • Drug nanoparticles by solvent evaporation with freeze-dried materials as scaffolds
  • Drug release with freeze-dried porous scaffolds
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    16:40

    Controlled crystallization of the lipophilic drug fenofibrate during freeze-drying

    Wouter Hinrichs

    Wouter Hinrichs, Assistant Professor Pharmaceutical Technology and Biopharmacy, University Of Groningen

  • Improved dissolution behavior BCS II drugs by application of nanocrystals
  • Bottom-up process to produce drug nanocrystals
  • Lyophilization using tertiary butyl alcohol as co-solvent
  • Elucidation of the mechanisms by in-line Raman spectroscopy

     

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    17:20

    Chairman’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Ahmad Abdul-Fattah

    Ahmad Abdul-Fattah , Scientist, Formulation and Process Development, Roche Pharmaceuticals

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    9:10

    Risk management approach and PAT tools to optimise lyophilisation robustness

    Yves Mayeresse

    Yves Mayeresse, Director of Manufacturing, GSK Biologicals

  • Introduction to risk management approach
  • The dependent and independent parameters in the lyophilisation process
  • The ICHQ9 and FMEA  applied to freeze-drying process analysis
  • How PAT tools can help to mitigate risk and increase robustness
  • Utility of the methodology in the frame of process development
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    9:50

    Comparison of spray drying and freeze drying technologies

    Sune Andersen

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

  • A critical analysis of the two techniques
  • Methodology and application of each method
  • Their relation to the industry as a whole
  • Conclusions on the two methods, and their relative benefits

     

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    10:30

    Morning Coffee

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    11:00

    Freeze dried powder flow analysis

    Edmond  Ekenlebie

    Edmond Ekenlebie, PhD Research Student, Aston University

  • Structural characterisation of freeze dried powder – XRay Micro CT and others
  • Benefits of free flowing powders, economical, packing and monitoring
  • Excipient use and cycle design
  • clock

    11:40

    Raman spectroscopy: A potential tool for obtaining real-time product information

    Sigrid Pieters

    Sigrid Pieters, PhD, Vrije Universiteit Brussel

  • A powerful tool for obtaining chemical and physical product information
  • Rapid discrimination between native and non-native proteins in freeze-dried formulations
  • Link mathematical model with biochemical knowledge
  • Transfer of the model to in-line use: how dealing with spectral interferences?
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    12:20

    Networking Lunch

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    13:20

    Aseptic processing of Freeze dried Medicinal or therapeutic products

    James  Drinkwater

    James Drinkwater, Chairman, Pharmaceutical and Healthcare Sciences Society

  • Key considerations in Aseptic processing of Freeze dried Biological products
  • Compatibility of biological decontamination agents with freeze dried biological products
  • Solutions for biological decontamination of Freeze dryer Automated Load-Unload systems (ALUS/Isolator/RABS/Rooms)
  • Developments in Freeze dryer bio-decontamination with Hydrogen peroxide vapour as an alternative to steam sterilization
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    14:00

    Experiences with the application of TEMPRIS®: a wireless, battery free PAT tool during the transfer from development scale to production scale

    Andrea  Weiland-Waibel

    Andrea Weiland-Waibel, Owner, Explicat Pharma GmbH

  • Experiences in applying MTM (Manometric Temperature Measurement) and Thermocouples in a Lyostar to develop a suitable lyo-cycle in the development scale to support formulation development
  • Application of TEMPRIS® in the Lyostar to perform lyophilization cycle robustness testings in the development scale
  • Stressing the product above the known critical temperature to understand the impact to be able to predict possible difficulties in the production scale
  • Experiences during the first two runs

     

  • clock

    14:40

    Optimisation of industrial freeze drying cycle - 2 real life examples

    Jean Rene Authelin

    Jean Rene Authelin, Global Head of Pharmaceutical Engineering, Sanofi-Aventis

  • Two examples of “old” products
  • How product physical characteristics (Tg’, eutectic melting, crystallization kinetics..), process mathematical modelling and the equipment intrinsic limitations are taken into account
  • How this assists in designing a safe and economically efficient freeze drying cycle
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    15:20

    Afternoon Tea

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    15:40

    R&D, production, management personnel interested in knowing about the importance of crafting a comprehensive and accurate URS

    Larry  Ulfik

    Larry Ulfik, President, Applewood Scientific

  • Is basic document referred to by all interested participants in a lyo project of any size
  • The ramifications of the URS
  • It’s uses in determining if vendor has completed producing the lyo, defining capability and therefore a regulatory benchmark document, defining the fit and finish of the lyo, determining space allocation for lyo placement
  • Determining operating environment available in facility

     

  • clock

    16:20

    Lyophilization Process Design, Development and Scale-up

    Sajal  Patel

    Sajal Patel, Scientist II, MedImmune

  • Guidelines for freeze-drying process design and development
  • General process development and scale-up challenges
  • PAT for freeze-drying
  • Advances in freeze-drying process monitoring and control
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    17:00

    Chairman’s Closing Remarks and Close of Day Two


    Head of Pharmaceutical Basic Development
    Boehringer Ingelheim Corporation
    Principal Scientist
    National Institute For Biological Standards & Control
    Principal Scientist Drying Processes
    Novo Nordisk A/s
    Lecturer, Pharmaceutics and Drug Delivery
    Aston University
    PhD
    Vrije Universiteit Brussel
    Chairman
    Pharmaceutical and Healthcare Sciences Society
    Scientist II
    MedImmune
    Global Head of Pharmaceutical Engineering
    Sanofi-Aventis
    President
    Applewood Scientific
    Owner
    Explicat Pharma GmbH
    Scientist, Formulation and Process Development
    Roche Pharmaceuticals
    Adjunct Associate Professor, Microbiology and Immunology
    University Of Tuebingen
    Program Manager Vaccine Technology
    National Institute for Public Health and the Environment
    Principal Scientist BioTherapeutics R&D
    Pfizer
    Head of Food Process Engineering and Microbiology
    INRA
    RCUK Academic Fellow
    University Of Liverpool
    Assistant Professor Pharmaceutical Technology and Biopharmacy
    University Of Groningen
    Director of Manufacturing
    GSK Biologicals
    PhD Research Student
    Aston University
    Formulation Scientist
    Agresearch

    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.

     

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