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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 SMi’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.
 

 

 

 

  

 

Key topics include:

  • Scaling up techniques and optimisation case studies
  • Lyophilisation monitoring, data analysis and risk reduction
  • Non-conventional formulation techniques and approaches
  • Moisture control and dried vaccine formulations
  • Ice nucleation control and monitoring
  • Product qualification and control
  • PAT, TDLAS, Raman Spectroscopy and optimal monitoring technologies and techniques
  • Aseptic processes and process design

 

This event is unmissable for professionals in the fields of:

  • Pharmaceutical and biologicals storage
  • Freeze-drying and lyophilisation
  • Research and development
  • Chemical engineering
  • Sterility
  • Product development
  • Outsourcing
  • Business development
  • Quality assurance and quality control
  • Protein stabilisation
  • Cold chain distribution
  • Freeze-dryer manufacturers
  • Pharmaceutical packaging & labelling
  • Pre-filled syringes
  • Quality by design
  • Up-scaling
  • Vaccine storage
  • Formulation
  • Clinical trial logistics
  • Regulatory compliance

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Patrick Garidel

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

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
  • 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
  • 10:30 Morning Coffee

    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
  • 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
  • 12:20 Networking Lunch

    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
  • 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
  • 14:50 Afternoon Tea

    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

     

  • 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
  • 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

     

  • 17:20 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Ahmad Abdul-Fattah

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

    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
  • 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

     

  • 10:30 Morning Coffee

    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
  • 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?
  • 12:20 Networking Lunch

    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
  • 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

     

  • 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
  • 15:20 Afternoon Tea

    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

     

  • 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
  • 17:00 Chairman’s Closing Remarks and Close of Day Two

    +

    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

    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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    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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