Home
overview

With increasing numbers of proteins being discovered, the importance of lyophilisation is coming to the fore, for example, as a means of extending the shelf life of pharmaceutical and biopharmaceutical products.
 

Ways of ensuring product quality and stability are key challenges for pharmaceutical professionals. Developments within freeze drying are advancing very rapidly, both in terms of technology and methodologies.


Further to the success of diverse pharmaceutical events, SMi is very pleased to present the 2nd annual Lyophilisation conference on 7-8 July 2014, London. This event will provide an update on methodologies for lyophilisation and examine how to mitigate risks in production. Gain practical information and tools which you can use and apply in the workplace.
 

Join our Lyophilisation forum and gain insight into current successes and challenges that leading pharma and biotech organisations are facing in the field. Evaluate ways in which to optimise your processes and product quality to assist you in your day-to-day role.
Key topics comprise:

• Lyophilisation cycle robustness testing
• Validation of freeze dryers
• Discover an update on controlled nucleation
• Process Analytical Technologies (PAT) and the tools
• Ensuring product quality for business 

 

The 2 day event will focus on the key developments within freeze drying and will cover debate and discussion of ways in which processes within lyophilisation can be optimised. It will also be a excellent opportunity to hear from key opinion leaders who are operating within the industry. Join Lyophilisation 2014 to gain the following:

  • Hear detailed insight into critical parameters through Lyorobustness
  • Key case study from MedImmune on advancements in lyophilised drug product development and scale-up
  • Discuss the costs versus benefits of optimising the lyophilisation process
  • Case study from Genzyme on mitigation strategies to minimise fogging in glass vials
  • Evaluate mathematical modelling in freeze drying
  • Gain insight into imaging analysis as a support tool for your freeze drying cycle
  • Analyse process analytical techniques for product visualisation during freeze drying

This event is 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

Meet the following this July: Boehringer Ingelheim, Allembis, Norgine, Explicat Pharma, MedImmune, Novo Nordisk, GlaxoSmithKline, Ellab, Ipsen, Ghent University, GEA Pharma Systems, GEA Process Engineering, Bavarian Nordic, Imperial College London, Chr. Hansen, LFB Technologies, University of Sao Paulo plus many more...

Here is a sample of organisations who have previously attended:

Abbvie Deutschland GmbH & Co. KG; Agresearch; Applewood Scientific; Aston University; BioPharma Technology; Boehringer Ingelheim; Dr.Mardon pharmaceutical company; Explicat Pharma GmbH; Fresenius Kabi; GEA Pharma Systems ; general organisation of import and export control; GlaxoSmithKline; Government Pharmaceutical Organization; GRIFOLS VIAJES SA; GSK; GSK Manufacturing S.p.A.; Imperial College; INRA; Intravacc; MedImmune; National Institute For Biological Standards & Control; National Institute Of Public Health And The Environment; NIBSC; Novo Nordisk A / S; Pfizer; Pharmaceutical and Healthcare Sciences Society; Roche Pharmaceuticals; Sanofi-Aventis; Theravectys; UCL; University Of Groningen; University Of Liverpool; University Of Tuebingen; Vrije Universiteit Brussel;

Conference programme

8:30 Registration and coffee

9:00 Chairman's opening remarks

Dr Andrea Weiland-Waibel

Dr Andrea Weiland-Waibel, Owner, Explicat Pharma GmbH

9:10 How to handle your freeze drying manufacturing equipment

Julie Pagenaud

Julie Pagenaud, Sterile Product Manufacturing Manager, Ipsen

  • Challenge of investment: new machine versus retrofitting / revamping
  • Qualification and validation strategies based on risk analysis approach
  • Project case study: from user requirements to manufacturing
  • 9:50 Physical Chemistry Considerations for the Lyophilisation of Biopharmaceuticals

    Sean Cullen

    Sean Cullen, Development Scientist, Genzyme Ireland Ltd in collaboration in University College Cork

     

             The role and impact of physical chemistry on the lyophilisation process, stability and structure of biopharmaceuticals
             The impact of lyophilisation process parameters on excipient state - crystalline versus amorphous and the methods of stabilisation by amorphous excipients
             Stresses experienced by proteins during the lyophilisation process
             Correlating moisture and the glass transition temperature during secondary drying to assess product stability

    10:30 Morning coffee

    11:00 The real time wireless validation of lyophilisation processes

    Jesper Møgelvang

    Jesper Møgelvang, Director, Sales and Marketing, Ellab Inc

  • Current real time lyophiliser temperature validation issues
  • TrackSense Pro Sky -80C wireless data-logger system
  • Reproducible results including industry examples
  • 11:40 Lyocycle development: the journey from labscale to production scale

    Dr Andrea Weiland-Waibel

    Dr Andrea Weiland-Waibel, Owner, Explicat Pharma GmbH

     

    ·          Linking critical quality attributes to process parameters – the development lyocycle
    ·          Risk assessment to establish the critical process parameters for transfer
    ·          Lyocyclerobustness testing on labscale to establish process boundaries
    ·          Use of PAT (TEMPRIS®)to mitigate the risk when transferring from labscale to production scale

    12:20 Networking lunch

    13:30 Advancements in Lyophilised Drug Product Development and Scale-up

    Jamie  Biddlecombe

    Jamie Biddlecombe, Formulation Development Scientist, MedImmune

     

    ·          Characterisation of lab-scale to manufacturing scale freeze-dryers for robust scale-up
    ·          Reducing cycle time - effect of drying above Tg’
    ·          PAT tools for lyophilisation

    14:10 Real-time evaluation of protection ability of stabilisers for protein formulations

    Thomas  De Beer

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

     

  • In-process visualization of protein-stabilizer interactions during freezing and drying
  • Comparison of stabilizing ability of different cryo- and lyoprotectants for protein formulations by in-process visualization
  • Evaluation of process analytical techniques for product visualization during freeze-drying
  • 14:50 Afternoon Tea

    15:20 Porous and nanofibrous polymeric structures by freeze-drying and some relevant applications

    Haifei  Zhang

    Haifei Zhang, Lecturer, Department of Chemistry, University Of Liverpool

  • ·          Ice-templating and freeze-drying: a versatile route for preparation of porous materials
  • ·          Combining emulsion-templating and freeze-drying: a systemic tuning of material porosity
  • ·          Drug nanocrystals by emulsion-freeze-drying and solvent evaporation within porous polymers
  • ·          Instantly forming emulsions by hand shaking with the freeze-dried porous polymers
  • 16:00 Experience with PAT implementation in pharmaceutical spray drying

    Sune Andersen

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

     

    ·          Types of PAT used in spray drying
    ·          Practical considerations in implementation of PAT
    ·          Case study: PAT applicability in a small scale spray dryer
    ·          Case study: PAT implementation and results in a production scale spray dryer

    16:40 Chairman's closing remarks

    17:00 Article - Mannitol hemihydrate

    European Journal of Pharmaceutics and Biopharmaceutics

    European Journal of Pharmaceutics and Biopharmaceutics, test, test

    8:30 Registration and coffee

    9:00 Chairman's opening remarks

    Dr Andrea Weiland-Waibel

    Dr Andrea Weiland-Waibel, Owner, Explicat Pharma GmbH

    9:10 Mathematical modelling, design and scale-up of freeze-drying cycles

    Dr Roberto Pisano

    Dr Roberto Pisano, Lecturer, Politecnico Di Torino

  • Mathematical models in freeze-drying science
  • Mathematical modelling for rapid cycle development: the strength and weakness of in-line and off-line methods, determination of model parameters, application to industrial equipment
  • Mathematical modelling for process transfer and scale-up: overview of benefits and drawbacks within model-based approaches, methodologies used to characterise heat and mass transfer in industrial apparatus, examples of scale-up of freeze-drying cycles
  • 9:50 Studying Lyophilisation Kinetics using Freeze Drying Microscopy

    Andy Stapley

    Andy Stapley, Senior Lecturer, Loughborough University

  • Using freeze drying microscopy to accurately measure collapse temperatures
  • Measuring sublimation kinetics from direct visualisation of sublimation front movement
  • Furthering our understanding of the factors affecting sublimation kinetics in vial based (and other) systems
  • Discussion of results for a model lactose system and comparisons with vial drying experiments

     

  • 10:30 Morning coffee

    11:00 3-stage validation approach for Lyophilised Products

    Massimo Rastelli

    Massimo Rastelli, Project Leader Biopharm, GlaxoSmithKline plc

  • Evaluating technology transfer of an existing commercial product
  • Developing a new lyophilised product
  • Discussion of advances in the lyophilisation field
  • 11:40 Controlled Nucleation in Manufacturing. Current State of Development

    Mark Shon

    Mark Shon, Vice President-Technology Development , SP Scientific

     

  • The ability to control nucleation during the freezing step is a relatively new advancement in freeze drying
  • Using the ControLyo™ Nucleation On-Demand Technology allows nucleation to occur at warmer temperatures, minimizing super-cooling. This results in larger ice crystals and reduced primary drying times.
  • Numerous other benefits have been shown in development freeze dryers equipped with ControLyo™ Technology.
  • Commercialization requires the technology work on production freeze dryers
  • This presentation describes how production dryers can be retrofit for ControLyoTM Technology and the results of two collaborative studies showing the feasibility of scale-up.
  • 12:20 Networking lunch

    13:20 The Importance of Physical Properties Analysis When Developing a Lyophilised Formulation

    Jason Gray

    Jason Gray, Consultant, Allembis Ltd

     

  • The critical nature of the glass transition temperature
  • Ensuring fit for purpose analytical techniques
  • Listening to the probes
  • 14:00 Effect of freeze-drying on the structure of therapeutic proteins loaded into nanoparticles

    Pedro Fonte

    Pedro Fonte, PhD Student, University of Porto

     

     

  • Optimisation of the freeze-drying process to better preserve the structure of the loaded protein
  • Loading of cryoprotectants
  • Freezing control
  • Protein structure maintenance and nanoparticle stabilisation
  • 14:40 Afternoon Tea

    15:10 Cryopreservation of mammalian cells via intracellular trehalose delivery

    Rongjun Chen

    Rongjun Chen, Lecturer in Chemical Engineering, Imperial College London

     

  • Overviewing the challenges in cryopreservation and lyophilisation of mammalian cells
  • Discussing the role of trehalose in cell cryopreservation / lyophilisation
  • Introducing a novel technology for intracellular loading of trehalose based on a non-toxic, membrane-permeating polymer
  • Demonstrating the application of the technology in cryopreservation of live cells
  • 15:50 Imaging analysis as a support tool for freeze drying cycle design

    Dr Sabrina Grassini

    Dr Sabrina Grassini, Professor, Politecnico Di Torino

  • Frequency domain imaging analysis: overview of main potentialities in the quality control of freeze dried products and in the design of industrial cycle
  • Imaging analysis for the prediction of the mass transfer resistance: laboratory results and transfer to industrial applications
  • Cycle design and industrial scale-up: benefits and drawbacks of the imaging approach in the optimisation of the cycle parameters
     
  • 16:30 Chairman's closing remarks

    +

    Sponsors and Exhibitors

    Sponsors and Exhibitors


    Veltek Associates Inc

    Sponsors and Exhibitors
    www.sterile.com

    Veltek Associates Inc. plays an innovative role to the pharmaceutical, biotechnology and medical device industries by developing products and services to improve operations and reduced costs associated with contamination. VAI offers a range of disinfectants, sporicides, cleaners, lubricants, environmental monitoring equipment, process cleaners, Core2Clean systems, laboratory testing and consulting services.

    Marriott Regents Park

    128 King Henry's Road
    London NW3 3ST
    United Kingdom

    Marriott Regents Park

    This 4 star north London hotel in zone 2 is the perfect destination for the astute business traveler as well as the leisure guest that knows how convenient north London hotels are, as a base from which to explore the city .Bond Street is just 3 stops from Swiss Cottage underground station on the Jubilee Line, so you can be shopping, exploring the sights and taking in one of London’s world-renowned West End shows in less than 15 minutes when you stay at this hotel near central London. At the same time, the hive of activity that is Camden Town, the chic shops, cafes and restaurants of Primrose Hill and ZSL’s London Zoo in Regents Park are all just a short walk from this hotel in north London.

    HOTEL BOOKING FORM

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download


    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

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    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




    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.