P-145_Lyophilisation-Europe(Final)

SMi Presents their 3rd Annual Conference on…

PLUS TWO HALF-DAY POST-CONFERENCE WORKSHOPSWednesday 1st July 2015, Holiday Inn Regents Park Hotel, London, UK

A: Spray Dry and FormulationWorkshop leaders: Jim Bullock, Director, iFormulate Ltd

David York, School of Chemical and Process Engineering, University of Leeds

8.30am - 12.30pm

B: Defining and implementing QbD in the design space for Scale up

Workshop leader: Pierre Lebrun, Experienced Statistician - Project Leader, Arlenda

1.30pm - 5.30pm

29- 30

JUNE2015

Holiday Inn Regents Park Hotel, London, UK

Lyophilisation -Europe

www.lyophilisationconference.comRegister online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711

ACADEMIC & GROUP DISCOUNTS AVAILABLE

BOOK BY 31ST MARCH AND SAVE £400BOOK BY 30TH APRIL AND SAVE £200BOOK BY 29TH MAY AND SAVE £100

CONFERENCE CHAIR: Poul Bertelsen,

Principal Scientist, Takeda

KEY SPEAKERS INCLUDE: • Yves Mayeresse, Director Primary and Secondary

Expertise, GSK• Patrick Garidel, Head of Pharmaceutical Basic

Development, Boehringer-Ingelheim• Eunice Costa, Process Development Engineer, Hovione• Sune Klint Andersen, Principal Scientist, Novo Nordisk A/S• Michael Dekner, Innovation Manager, Baxter Bioscience• Edith Lecomte-Norrant, GPS Innovation & Technology &

Sciences Director, UCB BioPharma

WHY ATTEND THIS EVENT:• Understand the fundamentals of freeze drying and

methods to optimise the process development• Learn how to integrate risk-based approaches into QbD

principles• Discuss strategies for improvement and areas of unmet

needs in our roundtable breakout session• Gain new insight of spray-drying methodologies to

achieving continues –processing• Strengthen understanding of how PAT can be applied in

lyophilisation.

@SMIPHARM

Protecting drug stability and optimising formulationdevelopment through robust PAT and QbD principles

Register online at: www.lyophilisationconference.com • Alternatively

Lyophilisation - EuropeDay One I Monday 29th June 2015

Supported by

8.30 Registration & Coffee

9.00 Chair’s Opening Remarks

Poul Bertelsen, Principal Scientist, Takeda

QUALITY BY DESIGN PRINCIPLES (QBD) AND SCALING UP OF LYOPHILISATION

OPENING ADDRESS

9.10 Applying Quality by Design Principles (QbD) and risk

assessment

• ICH guidelines

• The QbD process

• QRM management including examples

Poul Bertelsen, Principal Scientist, Takeda

9.50 The basics of freeze drying

Patrick Garidel, Head of Pharmaceutical Basic

Development, Boehringer-Ingelheim

10.30 Morning Coffee

11.00 Keynote address: Implementation of

QbD in lyophilisation

• Improving flexibility and robustness of

the process design

• Quantitative performance measures to ensure product

quality

• Identifying stabilising excipients to ensure drug stability

• Evaluating risk factor of material attributes

Yves Mayeresse, Director Primary and Secondary Expertise,

GSK

11.40 Important considerations for scale-up

• From lab to large scale

• A generic approach to scale-up

• Challenges of scale up

Michael Dekner, Innovation Manager, Baxter Biosciences

12.20 Networking Lunch

1.30 Round table breakout session: • Group introductions and discussion

of challenges met • Examine opportunities to implement and

optimise the application of QbD principles in process development.

• Share concerns, success stories and major areas forimprovement

MODELLING PROCESS DEVELOPMENT

2.10 Spray-drying process development and scale-up forcomplex dosage forms: an alternative to lyophilisation • A viable alternative for achieving continuous production • Benchmarking lyophilisation with spray drying• Challenges in spray drying process and formulation

development for complex dosage forms• Maintaining product critical quality attributes across scales • Case study: Scale-up of spray dried formulationsEunice Costa, Process Development Engineer, Hovione

2.50 Crystal nucleation: Theory and modelling• Classical nucleation theory• Multi-step nucleation• Molecular simulation of crystal nucleation• Modulation of crystal nucleation using additivesJamshed Anwar, Associate Dean for Research & Professor of Computational Chemistry, Lancaster University

3.30 Afternoon Tea

4.00 The mechanical properties of lyophilised cakes • The properties of mechanical properties of lyophilised

cakes are a potential QbD property• Discussion: The mechanical properties of protein-based

lyophilized cakes Daryl Williams, Reader in Particle Science, Imperial CollegeLondon

4.40 Panel discussion: • Review PAT and QbD principles and discuss

current challenges facing scale up and quality control

• Discuss opportunities for continuous lyophilisation • Identify ways to bridge the gap between commercial and

laboratory lyophilisationPanel leader: Yves Mayeresse, Director Primary andSecondary Expertise, GSKPanellists: Eunice Costa, Process Development Engineer, HovioneMichael Dekner, Innovation Manager, Baxter Biosciences

5.20 Chair's Closing Remarks and Close of Day One

Official media partner Leading media partner

KeynotePresentation

fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

Lyophilisation - EuropeDay Two I Tuesday 30th June 2015

8.30 Registration & Coffee

9.00 Chair’s Opening Remarks

Poul Bertelsen, Principal Scientist, Takeda

PROCESS ANALYTICAL TECHNOLOGIES (PAT)

OPENING ADDRESS

9.10 Scale up methodologies for spray drying processes

• A viable alternative to achieving continuous production

• Optimising solution/suspension properties to maintain

critical quality attributes

• Challenges with atomization

• Case study: Spray drying of nanoparticles

Sune Andersen, Principal Scientist, Novo Nordisk A/S

9.50 Morning round table discussion

• How does PAT support scale up processes

and to what degree has it been successful?

• Discuss critical issues and major cost drivers

currently faced in scale up

• Discuss experiences with filing QbD reports and fulfilling

the requirements of PAT

10.30 Morning Coffee

11.00 The value of modelling in spray dried product development

• Understanding process influence and scale

• Predicting product structure and product quality

• Efficient approaches with models and experiments

Andrew Bayly, Chair in Chemical Engineering, Institute of

Particle Science and Engineering, University of Leeds

11.40 Engineering a continuous process to ensure

end product quality

• Controlling product structure and

homogeneity during freezing

• Process intensification and economic factors in scale up

• Integration with upstream and downstream operations

• Design for scalability and robust technology transfer

Bruce Williams, Managing Director, Williams Process Ltd

12.20 Networking Lunch

1.30 Enabling technologies in lyophilisation processes• New approaches and robust technology transfer • Recognising the need for and challenges of continuous

production in industry • Case studyAndrew Tait, Postgraduate Research Engineer, NewcastleUniversity

CONTINUOUS IMPROVEMENT TO ENSURE PRODUCT QUALITY

2.10 Implementing QbD tools to optimise product quality• Integrating risk-based approaches

into QbD principles • Maintaining continuous process

validation and control of process parameters. • Case study on material flowPierre Lebrun, Experienced Statistician - Project Leader,Arlenda

2.50 PAT on Pharmaceutical Processes• Benefits of PAT in process development • Implementing new technology in for PATEdith Norrant, GPS Innovation & Technology & SciencesDirector, UCB BioPharma

3.30 Afternoon Tea

4.00 Panel discussion: • Application of Quality-by-Design to process

development- Which steps are it most often applied to?

Is it relevant to apply it to all steps?- How often is it used in IMPDs/CTAs?- Experience with filing equations?

• Discuss the unique challenges facing design of experiments • Future prospects for continuous production processes • Critical issues and major cost drivers with technology

transfer in scale up Panel leader: Sune Klint Andersen, Principal Scientist NovoNordisk A/SPanellists: Edith Norrant, GPS Innovation & Technology & SciencesDirector, UCB BioPharmaBruce Williams, Managing Director, Williams Process Ltd Andrew Tait, Postgraduate Research Engineer, NewcastleUniversity

4.40 Chair’s Closing Remarks and Close of Day Two

Want to know how you can getinvolved? Interested in promoting

your services to this market?Contact Teri Arri, SMi Marketing

on +44 (0) 20 7827 6162, or email: [email protected]

EngineeringSpotlight

KeynoteAddress:

Critical validationprocesses andrisk-based QbD

HALF-DAY POST-CONFERENCE WORKSHOP A:Wednesday 1st July 2015

8.30am - 12.30pmHoliday Inn Regents Park Hotel, London, UK

Spray Dry and Formulation 

Workshop leaders: Jim Bullock, Director, iFormulate Ltd

David York, School of Chemical and ProcessEngineering, University of Leeds

Overview of workshop:

Spray drying is an important manufacturing process forpharmaceuticals and other formulated products. Theworkshop will cover:• What properties are needed in a spray-dried

formulated product?• How are these properties measured?• How can the formulation and process conditions be

designed to create the desired properties?

The workshop will include an overview of the sciencebehind spray drying, some relevant industrial examples aswell as an interactive group session.

Why should delegates attend this workshop: 

Attendees will receive a valuable grounding in thescience and technology of spray drying and how this canbe used in designing formulations and using formulationprocesses.

Programme

8.30 Registration and coffee

9.00 Opening Remarks

9.15 Spray drying principles

10.15 Modelling for spray drying

10.45 Coffee Break

11.15 Spray drying and formulated product properties

11.45 Interactive group session

12.15 Closing remarks

12.30 End of workshop

About the workshop leaders:

Dr Jim Bullock is co-founder and director of iFormulateLtd. Previously he was CEO of Intelligent Formulation Ltdwhich promoted formulation technology in the UK.

After a D.Phil from Oxford, Jim led R&D projects inimaging at Ilford Ltd and activities on crystal engineeringand dye formulation and chemistry at ICI/Zeneca. AtBASF, in UK and Germany, he headed formulationdevelopment for colours and held marketing, strategy,R&D and regulatory affairs functions for BASF’s globalbiocides business and was also a board director of AgionTechnologies, USA.

Jim is co-director of the CPD course “Spray Drying andAtomisation of Formulations”, run by the University ofLeeds.

David York holds the chair of Structured ParticulateProducts in the department of Chemical Engineering andis also Director of the High Value Chemical Manufacturinghub which is focussed on increasing the interactionsbetween the university academics and industry to driveresearch and impact. Part of this work included setting upand managing the Strategic Partnership with P&G. He iscurrently working with the KTN to help develop proposalsfor a National Centre for Formulation and also sits on theI ChemE Research Committee developing a strategy forchemical engineering research in the UK.

David is a chemical engineer with 35 years’ experience inindustrial R&D inside P&G, has sat on the EPSRC StrategicAdvisory Network and chairs the Industrial advisory teamfor UCL’s IMRC in Macro molecules. He is a visitingprofessor at the Universities of Birmingham and Bristol andis both a Fellow of the IChemE and the Royal Academyof Engineering.

About the organisation:

iFormulate Ltd was founded to provide customised R&Dand innovation services to companies working in the fieldof Formulation Science and Technology. We offerconsultancy, project management, idea generation anddevelopment, assistance with commercialisation, marketand business development, training andevents.www.iformulate.biz

HALF-DAY POST-CONFERENCE WORKSHOP B:Wednesday 1st July 2015

1.30pm - 5.30pmHoliday Inn Regents Park Hotel, London, UK

Defining and implementing QbD inthe design space for Scale up 

Workshop leader: Pierre Lebrun, ExperiencedStatistician - Project Leader, Arlenda

Overview of workshop:

• QbD –define, design, characterize, validate,and monitor to meet the quality attributesnecessary for clinical performance

• Design Space, a (predictive) risk-basedapproach

• Working in Phase I-III process validation• Case studies, group - problem solving exercises

and interactive discussion

The workshop will include an overview of thescience behind spray drying, some relevantindustrial examples as well as an interactive groupsession.

Programme

1.30 Registration and coffee

2.00 Opening Remarks

2.10 Session1: QbD applied to pharmaceuticalprocess

2.50 Session 2: linking CPP to clinical relevancethrough process understanding

3.30 Coffee Break

4.00 Session 3: Case studies: beginning a QbDanalysis from development to processvaldiation

4.40 Session 4: Q/A + discussions

5.20 Closing remarks

5.30 End of workshop

About the workshop leader:

Pierre Lebrun has a master degree in computersciences and economy, followed by a master instatistics at the university of Louvain-la-Neuve inBelgium. Next, he completed his PhD in statistics in2012 at the university of Liege (Belgium), in thetopic of Bayesien models and Design Spaceapplied to Pharmaceutical industry. Pierre is nowworking for Arlenda, a Belgian companyspecialized in biostatistics for pharmaceuticaldevelopment. Topics of interest include Quality byDesign, (bio) assay development, validation andgeneral statistics for the manufacturing andrelease of drugs and vaccines, using effectiveDesign Space strategies.

About the organisation:

Arlenda is a companyspecialized in advancedclinical and non-clinicalstatistics for the Pharma industry. Arlenda aims atimplementing QbD thinking, Bayesian thinking,and modeling and simulations in perfectaccordance with the latest guidelines andregulatory requirements. Arlenda also developssoftwares for the validation, transfer, and routineof analytical and bio analytical assays, and forstability studies.

FAX your booking form to +44 (0) 870 9090 712PHONE on +44 (0) 870 9090 711

POST your booking form to: Events Team, SMi Group Ltd, 2nd FloorSouth, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK

LYOPHILISATION - EUROPE Conference: Monday 29th & Tuesday 30th June 2015, Holiday Inn Regents Park Hotel, London, UK Workshops: Wednesday 1st July 2015, London

4 WAYS TO REGISTERwww.lyophilisationconference.com

If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email [email protected]

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