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2015Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

Lyophilisation andFreeze Drying USA

29th & 30th

APRIL

CHAIR FOR 2015: Andrea Weiland, Managing Director,

Explicat Pharma GmbH

KEY SPEAKERS INCLUDE: • Swapnil Pansare, Associate Scientist – I, Formulation Sciences,

MedImmune• Akhilesh Bhambhani, Principal Scientist, Novel Adjuvants,

Formulations and Delivery Technologies, Merck & Co. Inc.• Vikram Sadineni, Senior Research Investigator-II,

Bristol-Myers Squibb • Mark Yang, Director, Fill Finish Development, Genzyme • Sune Andersen, Principal Scientist in Drying Processes and Particle

Technology in CMC, Novo Nordisk A/S, Denmark• Graham Magill, Engineer I, Pharmaceutical Processing and

Technology Development, Genentech Inc. • Ronald Pate, Lyophilisation Development Scientist,

Patheon Pharmaceuticals Inc.

BENEFITS OF ATTENDING IN 2015:

• This scientifically sound conference will focus on processformulation and optimisation for biologics and vaccines with akey focus on the development of lyophilisation and scale up

• All challenges in lyophilisation and freeze drying technologywill be considered and case studies will reflect and addressthe implementation process

• It’s important to have an up-to-date perspective of thelyophilisation process as a whole and the application informulating solid protein pharmaceuticals. This conference will review the challenges to enhance improvements

• Don’t miss out on our round table discussion, focusing onquality by design and the future of lyophilisation

PLUS AN INTERACTIVE POST-CONFERENCE WORKSHOPFRIDAY 1ST MAY 2015

Quality by Design Strategies for Lyophilisation

Workshop Leader: Kevin Ward, Director of Research & Development, Biopharma Technology Limited

8.30am – 12.30pm

SMi presents its 3rd in the series of conferences on...

BOOK BY 30TH JANUARY 2015 AND SAVE $400 • BOOK BY 27TH FEBRUARY AND SAVE $100

Sponsored by

Parenteral Contract Manufacturing Service of Hospira

Register online at: www.lyophilisation-usa.com • Alternatively fax

Lyophilisation And Freeze Drying Day One | Wednesday 29th April 2015

8.30 Registration & Coffee

9.00 Chairs Opening RemarksAndrea Weiland, Managing Director, Explicat Pharma GmbH

ADVANCES AND DEVELOPMENTS IN LYOPHILISATION AND FREEZE DRYING

9.10 Cycle development basic concepts and optimising the process • Reviewing cycle development to enhance optimisation,

validation and increased stability of the protein• Enabling shorter cycle times for cost efficient processing of

lyophilised formulations• Ensuring consistency within a batch and between batches Ronald Pate, Lyophilisation Development Scientist,Patheon Pharmaceuticals Inc.

9.50 What is lyophilisation? • An overview of the process of lyophilisation and evaluating

the scale up from lab to production• Factors for consideration, either changing from sites or from

one freeze drying type to another• What parameters should be reviewed to optimise the processReingard Schandl, Process Expert, Lyophilisation, Baxter AG*

10.30 Advances in Temperature Mapping inside Lyophilizers• Real-time wireless temperature data• Wireless Vacuum measurement• Accessories for Probe placement• Advanced Data Analysis FeaturesTim Paymaster, President, Ellab Inc.

11.10 Morning Coffee

11.30 CASE STUDY Improving Lyophilisation Process Efficiency via Primary Drying Optimisation• Case study of freeze-drying protein above and

below Tg’ and its impact on drug product quality• Improvement in process efficiency for lyophilising biologics

above Tg’ at a commercial scale• Scale up challenges for drying above Tg’Swapnil Pansare, Associate Scientist – I, Formulation Sciences,MedImmune

12.20 New Formulation Technologies for Stabilization of TherapeuticProteins & Vaccines• Enabling Technologies for Formulation Development • Case Studies documenting enhanced stability of vaccines

and Monoclonal(s) in newly enabled formulation• Summary and Path ForwardAkhilesh Bhambhani, Principal Scientist, Novel Adjuvants,Formulations and Delivery Technologies, Merck & Co. Inc.

QUALITY BY DESIGN IN THE SPOTLIGHT

1.00 Case Study: Adapting a lyophilization cycle from pirani tocapacitance manometer gauge pressure control• The Pirani pressure gauge reports a higher pressure than the

true pressure in the lyo chamber relative to the percent ofwater vapor in the chamber

• The pressure in the lyo chamber has an impact on the dryingrate and final water content of the product

• Fixed-time lyo cycles lead to different results:

Case 1 – lower pressure slowed primary drying, leading to higher water content

Case 2 – lower pressure improved secondary drying, leading to lower water content

Robert Stoner, Hospira Research and Development, One 2 One Hospira

1.40 Networking Lunch

2.40 Leveraging Sophisticated Modelling in QbD – Why Bother? • What are the desirable elements of a modelling method?• Introduction to Bayesian Methods• Application of Bayesian Methods to QbD for lyophilisationTara Scherder, Managing Director, Arlenda, Inc

3.20 KEYNOTE ADDRESSApplying QbD to Freeze-Drying: Space and Time, Risks andPracticalities• The challenge of applying a QbD approach to a process with

a dynamic risk profile• How can we visualise a Design Space for freeze-drying?• Balancing desktop studies with practical lyophilisationKevin R Ward, Director of R&D, Biopharma Technology Limited

4.00 Afternoon Tea

4.30 Drug Product Development Using a QbD approach forCommercialization• DoE Based Approach to Process Development• Application of Modeling Tools in Process Scale-up and

CommercializationVikram Sadineni, Senior Research Investigator-II, Bristol-Myers Squibb

5.10 Quality by Design in Freeze Dry Process Development• Construction of a primary drying design space and its’

advantages and limitation.• QbD approach to residual moisture specifications and

implications on secondary drying cycle development.• Benefits of process analytical technology for lyophilizationLindsay Wegiel, Research Associate III, Baxter Pharmaceutical Solutions

5.50 ROUND TABLE DISCUSSION

Leader: Andrea Weiland, Managing Director, Explicat Pharma GmbH

6.30 Chairs Closing Remarks and Close of Day One

NEW FOR2015

PARTONE!

NEW FOR2015

Future prospects forpharmaceutical freeze-drying• Assessing the advances in

alternative dryingtechnologies

• Could new technologiessignal the end of freezedrying?

• Evaluating the ways topreserve and stabiliseproteins as an alternativeto freeze drying

Quality by Design Strategiesfor lyophilisation• The application of QbD

strategies to lyophilisation• Exploring best practices

to ensure the productmeets the desired qualityattributes

• Practical examples,assessing the role ofQuality by Design inbiopharmaceuticalmanufacturing

• Focussing attention on riskmanagement, integrationand implementation inaddition to cost benefits

*Subject to Final Confirmation

Parenteral Contract Manufacturing Service of Hospira

FEBRUARY

Parallel Trade9th – 10th February 2015

Holiday Inn Regents Park, London

Advances and Progress in Drug Design16th – 17th February 2015

Marriott Regents Park, London

RNAi Therapeutics16th – 17th February 2015

Marriott Regents Park, London

MARCH

Superbugs & Superdrugs – A focus onAntibacterials

25th – 26th March 2015Holiday Inn Regents Park, London

Paediatric Clinical Trials25th – 26th March

Holiday Inn Regents Park, London

APRIL

Asthma & COPD 13th – 14th April 2015

Holiday Inn Regents Park, London

Controlled Release20th – 21st April 2015, London

Adaptive Designs20th – 21st April 2015, London

Pre Filled Syringes USA27th – 28th April 2015, Iselin, USA

Lyophilisation and Freeze Drying USA29th – 30th April 2015, Iselin, USA

MAY

Pharmacovigilance, Drug Safety & Risk Management

11th – 12th May 2015, London

Pain Therapeutics18th – 19th May 2015, London

ADC Summit 201518th – 19th May 2015, London

Clinical Trial Logistics20th – 21st May 2015, London

JUNE

ADMET29th – 30th June 2015, London

SMI'S PHARMACEUTICAL PORTFOLIO 2015

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

Lyophilisation And Freeze Drying Day Two | Thursday 30th April 2015

8.30 Registration & Coffee

9.00 Chairs Opening RemarksAndrea Weiland, Managing Director, Explicat Pharma GmbH

PROCESS ANALYTICAL TECHNIQUES & STRATEGIES

9.10 OPENING ADDRESSImplementation of PAT to enhance lyo cycle development androbustness• New PAT available to monitor lyo process in real time for cycle

development and optimization • PAT and strategies for lyo robustness, process scale up, and

technology transfer• PAT to monitor the residual moisture and other product

qualities inline/online and to assess lyo product stabilityMark Yang, Director, Fill Finish Development, Genzyme

9.50 PAT in the freeze drying of parenteral products • The use of PAT for process development and manufacturing

controls• The application of process analytical technologies across

various scales• New impedance based technologies for molecular to

macroscopic scale measurementsGeoff Smith, Reader Pharmaceutical Technologies, School ofPharmacy, De Montfort University

10.30 Freeze Drying PAT using Heat Flux Measurement• Overview of Heat Flux Sensing, the latest Process Analytical

Technology that works in both freezing and primary drying• Heat Flow during freezing effects ice crystal formation.

Examine how different freezing profiles effect primary dryingtimes. Examine how controlled nucleation may/may not havean impact on shortening primary drying

• Measuring heat flow during primary drying enables protocoldevelopment for easy process transfer

Todd Thompson, President, Millrock Technology, Inc.

11.10 Morning Coffee

11.40 KETNOTE ADDRESSHot and cold spot determination to allow for process control byuse of Product Temperature Tp PAT Device • Dynamic Hot and Cold Spot Determination as Performance

Qualification• Evaluation/Definition of most critical "hot and cold spots" to be

instrumented with the real time PAT Device• Use of the Real Time PAT to control the freeze-drying cycleAndrea Weiland, Managing Director, Explicat Pharma GmbH

12.20 Controlled Nucleation in Production Lyophilizers: Current State ofthe Technology• Controlled nucleation has shown in development labs to offer

significant benefits, including shortened primary drying cycles.• ControLyo™ Nucleation On-Demand Technology has been

both incorporated into new production dryers and retrofit ontoexisting dryers.

• The results of two retrofit studies done with major Pharmacompanies will be presented

Mark Shon, Vice President, Technology Development, SP Scientific

1.00 Networking Lunch

2.00 Spray drying as an alternative to freeze drying • Aseptic drying for parenterals – spray vs. freeze drying• Nanoparticles by freeze drying and spray drying approaches• QbD – comparison between spray and freeze dryingSune Andersen, Principal Scientist in Drying Processes andParticle Technology in CMC, Novo Nordisk A/S, Denmark

2.40 INDUSTRY INSIGHT - An Example SolutionApplication of Controlled Ice Nucleation for Lyophilization of aLow Glass Transition Temperature Solution• Discuss the application of Praxair ControLyo controlled ice

nucleation technology to optimize the lyophilization of a lowglass transition temperature (Tg’), high fill volume product

• Assessing the impact of processing parameters such as icenucleation temperature and post-nucleation cooling ramprate on cake microstructure will be discussed

Graham Magill, Engineer I, Pharmaceutical Processing andTechnology Development, Genentech Inc.

3.20 Afternoon Tea

ADVANCES AND DEVELOPMENTS IN LYOPHILISATION AND FREEZE DRYING

3.50 Case Study: The role of physical chemistry in freeze-drying fromproduct characteristics to process performance• A success story of a lyophilised product to market and how to

develop them• Utilising a high through put approach for lyophilisation and

optimisation• Factors in formulators as a thought in design strategy Tudor Arvinte, Professor University of Geneva, Chairman & CEO,Therapeomic Inc.

4.30 Concentrated solid dosage formulations of therapeutic biologics • Ensuring high dosage delivery of proteins - the case for a solid-

state approach• A perspective on the scale of the challenge faced and a

review of the methods used •Is reconstitution using centrifugation the answer?Barry Moore, CSO, Xstalbio Ltd

5.10 Concentrated dosage formulations effecting biologics and solidtherapeutics • A perspective on the scale of the challenge faced and the

methods to be reviewed as a solution• Is reconstitution using centrifugation the answer?• Ensuring high dosage delivery of proteinsJamie Tsung, Principal Scientist, Momenta Pharmaceuticals, Inc.

5.50 Chairs Closing Remarks and Close of Day Two

Interested in promoting your services to this market?Contact Teri Arri, SMi Marketing on +44 (0) 207 827 6162 or email tarri@smi-online.co.uk

NEW FOR2015

PARTTWO!

Official Media Partner

Supported by

HALF-DAY POST-CONFERENCE AM WORKSHOPFriday 1st May 20158.30am - 12.30pm

Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

Quality by Design Strategies for Lyophilisation

Workshop Leader: Kevin Ward, Director of Research &

Development, Biopharma Technology Limited

Overview of workshop:

Quality by Design (QbD) is an approach that hasbeen implemented in many manufacturingsettings and across a broad range of industrialsectors. Its application is ever widening to cover alarge number of processes that may previouslyhave been considered to be outside its remit orgrasp. In recent years, the application of theQbD approach to freeze-drying has been thesubject of a small number of published studies,although there is arguably a long way to gobefore Best Practice can be agreed and opinionsharmonized.

This half-day Workshop on QbD in Lyophilization willcover a number of aspects of the QbD approachand how it might be successfully applied to thefreeze-drying process, as well as upstreamactivities (formulation, filling, loading) and post-drying issues.

Why attend this workshop:

Delivered as a combination of short presentationson QbD concepts and case studies, interspersedwith discussion sessions and small groupworkexercises, the Workshop is designed to be aninteractive session where participants are alsoinvited to share their views and experiences withfellow attendees to gain maximum value from thesession.

Programme

8.30 Registration and Coffee

9.00 Introduction and Opening Remarks

9.10 Can the QbD approach be applied toformulation and cycle development as anintegrated process?

9.50 How can the different risks arising withinthe freezing and drying stages of theprocess be assessed/accommodated?

10.30 Coffee Break

11.00 Is it possible to find a good balance ofdesktop studies and practical freeze-dryingthat won’t be unnecessarily onerous?

11.40 What level of detail should we go to inassessing the risk and generatingsupporting data?

12.20 Discussion and Q&A

12.30 Close of Workshop

About the Workshop Leader:

Kevin Ward is R&D Director at BTL, a UK-based company specializing in providingfreeze-drying services and training to thepharmaceutical, diagnostics and biotech

sectors. Following a BSc in Chemistry and a PhD inpharmaceutical freeze-drying, Kevin joined BTL in2000. Since then, he and his team have helpedmore than 400 companies worldwide, beeninvolved in the development of over 1000products, 2 analytical instruments, and trainedmore than 2500 people. Kevin publishes andlectures internationally lyophilisation and theanalytical- and product- related issues associatedwith the technology. He is also a Fellow of theRoyal Society of Chemistry.

SPONSORSHIP AND EXHIBITION OPPORTUNITIES

SMi offer sponsorship, exhibition, advertising andbranding packages, uniquely tailored to complementyour company’s marketing strategy.

Prime networking opportunities exist to entertain,enhance and expand your client base within the contextof an independent discussion specific to your industry.

Should you wish to join the increasing number ofcompanies benefiting from sponsoring ourconferences please call: Alia Malick on+44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk

As a leading manufacturer of complete thermal validationsolutions, Ellab is devoted to increase consumer safety byproviding accurate and reliable measurement products.Ellab’s solutions measure, record, monitor, and validatecritical parameters of thermal processing in thepharmaceutical and biotech industries. www.ellab.com

Hospira’s One 2 One™business is a leading global injectableproduct CMO. With more than 25 years of experience inbiologic and small molecule fill & finish manufacturing, in-depth knowledge of lyophilization process, and expertise inmultiple drug delivery technologies, One 2 One™ is areliable partner to help achieve customer developmentand commercialization goals. http://one2onecmo.com

Experience Since 1957 ~ Freeze Drying is Our Focus MillrockTechnology is always looking to provide new innovations tothe freeze drying industry. Innovation leaders are those whoare either able to better understand customer requirementsand exploit new market opportunities, or access newtechnologies to deliver successful new products andservices. As an innovator, Millrock Technology listens to theneeds of the market, while providing value in our productline. We offer cutting-edge technologies and optimizedmethods of freeze drying. Millrock Technology manufacturesSERIOUS freeze dryers, customized for thepharmaceutical/biotech marketplace. We focus on onetechnology and one market to best satisfy our customers’needs. www.millrocktech.com

SP Scientific, leaders in freeze drying innovation, invites you tospeak with a representative to learn more about howControLyo™ Technology, available for pilot to productionscale lyophilizers, has improved the freeze-drying industry.Ask about retrofitting your existing unit with ControLyo™Technology. www.SPScientific.com

TEMPRIS® will be presented at Lyophilisation USA in NewJersey from 29th to 30th April 2015.Please come to our boothon 2nd floor and discuss with us about new technologiesand procedures in the freeze drying area. Our productTEMPRIS® is designed to help customers to reduceproduction cost by supporting lyocycle development,scale-up and transfer. Thus TEMPRIS® enhances theimplementation of new validation concepts, helps to assureGMP Compliance under cost pressure and in the endprovides overall savings in pharmaceutical production.TEMPRIS® is already recognized as an interesting PAT tooland will certainly continue to grow in importance. We lookforward to welcoming you in New Jersey and responding toyour specific demand. www.iqmobil.com

Parenteral Contract Manufacturing Service of Hospira

Lyophilisation and Freeze Drying USA 2015

Sponsored by

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

LYOPHILISATION AND FREEZE DRYING USAConference: Wednesday 29th & Thursday 30th April 2015, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA Workshops: Friday 1st May 2015, USA

4 WAYS TO REGISTERwww.lyophilisation-usa.com

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