SMi Group has added Lyophilisation to its portfolio of North American conferences in 2015.

1. @SMIPHARM
www.lyophilisation-usa.com
BOOK BY 30TH JANUARY 2015 AND SAVE $400 • BOOK BY 27TH FEBRUARY AND SAVE $100
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
ACADEMIC & GROUP DISCOUNTS AVAILABLE
2015Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
Lyophilisation and
Freeze 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 process
formulation and optimisation for biologics and vaccines with a
key focus on the development of lyophilisation and scale up
• All challenges in lyophilisation and freeze drying technology
will be considered and case studies will reflect and address
the implementation process
• It’s important to have an up-to-date perspective of the
lyophilisation process as a whole and the application in
formulating solid protein pharmaceuticals. This conference
will review the challenges to enhance improvements
• Don’t miss out on our round table discussion, focusing on
quality by design and the future of lyophilisation
PLUS AN INTERACTIVE POST-CONFERENCE WORKSHOP
FRIDAY 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

2. 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 Remarks
Andrea 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 process
Reingard 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 Features
Tim 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 Therapeutic
Proteins & Vaccines
• Enabling Technologies for Formulation Development
• Case Studies documenting enhanced stability of vaccines
and Monoclonal(s) in newly enabled formulation
• Summary and Path Forward
Akhilesh 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 to
capacitance manometer gauge pressure control
• The Pirani pressure gauge reports a higher pressure than the
true pressure in the lyo chamber relative to the percent of
water vapor in the chamber
• The pressure in the lyo chamber has an impact on the drying
rate 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 lyophilisation
Tara Scherder, Managing Director, Arlenda, Inc
3.20 KEYNOTE ADDRESS
Applying QbD to Freeze-Drying: Space and Time, Risks and
Practicalities
• 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 lyophilisation
Kevin R Ward, Director of R&D, Biopharma Technology Limited
4.00 Afternoon Tea
4.30 Drug Product Development Using a QbD approach for
Commercialization
• DoE Based Approach to Process Development
• Application of Modeling Tools in Process Scale-up and
Commercialization
Vikram 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 lyophilization
Lindsay 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 FOR
2015
PART
ONE!
NEW FOR
2015
Future prospects for
pharmaceutical freeze-
drying
• Assessing the advances in
alternative drying
technologies
• Could new technologies
signal the end of freeze
drying?
• Evaluating the ways to
preserve and stabilise
proteins as an alternative
to freeze drying
Quality by Design Strategies
for lyophilisation
• The application of QbD
strategies to lyophilisation
• Exploring best practices
to ensure the product
meets the desired quality
attributes
• Practical examples,
assessing the role of
Quality by Design in
biopharmaceutical
manufacturing
• Focussing attention on risk
management, integration
and implementation in
addition to cost benefits
*Subject to Final Confirmation
Parenteral Contract Manufacturing Service of Hospira
FEBRUARY
Parallel Trade
9th – 10th February 2015
Holiday Inn Regents Park, London
Advances and Progress in Drug Design
16th – 17th February 2015
Marriott Regents Park, London
RNAi Therapeutics
16th – 17th February 2015
Marriott Regents Park, London
MARCH
Superbugs & Superdrugs – A focus on
Antibacterials
25th – 26th March 2015
Holiday Inn Regents Park, London
Paediatric Clinical Trials
25th – 26th March
Holiday Inn Regents Park, London
APRIL
Asthma & COPD
13th – 14th April 2015
Holiday Inn Regents Park, London
Controlled Release
20th – 21st April 2015, London
Adaptive Designs
20th – 21st April 2015, London
Pre Filled Syringes USA
27th – 28th April 2015, Iselin, USA
Lyophilisation and Freeze Drying USA
29th – 30th April 2015, Iselin, USA
MAY
Pharmacovigilance, Drug Safety
& Risk Management
11th – 12th May 2015, London
Pain Therapeutics
18th – 19th May 2015, London
ADC Summit 2015
18th – 19th May 2015, London
Clinical Trial Logistics
20th – 21st May 2015, London
JUNE
ADMET
29th – 30th June 2015, London
SMI'S PHARMACEUTICAL PORTFOLIO 2015

3. 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 Remarks
Andrea Weiland, Managing Director, Explicat Pharma GmbH
PROCESS ANALYTICAL TECHNIQUES & STRATEGIES
9.10 OPENING ADDRESS
Implementation of PAT to enhance lyo cycle development and
robustness
• 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 stability
Mark 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 measurements
Geoff Smith, Reader Pharmaceutical Technologies, School of
Pharmacy, 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 drying
times. Examine how controlled nucleation may/may not have
an impact on shortening primary drying
• Measuring heat flow during primary drying enables protocol
development for easy process transfer
Todd Thompson, President, Millrock Technology, Inc.
11.10 Morning Coffee
11.40 KETNOTE ADDRESS
Hot and cold spot determination to allow for process control by
use 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 cycle
Andrea Weiland, Managing Director, Explicat Pharma GmbH
12.20 Controlled Nucleation in Production Lyophilizers: Current State of
the 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 onto
existing dryers.
• The results of two retrofit studies done with major Pharma
companies 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 drying
Sune Andersen, Principal Scientist in Drying Processes and
Particle Technology in CMC, Novo Nordisk A/S, Denmark
2.40 INDUSTRY INSIGHT - An Example Solution
Application of Controlled Ice Nucleation for Lyophilization of a
Low Glass Transition Temperature Solution
• Discuss the application of Praxair ControLyo controlled ice
nucleation technology to optimize the lyophilization of a low
glass transition temperature (Tg’), high fill volume product
• Assessing the impact of processing parameters such as ice
nucleation temperature and post-nucleation cooling ramp
rate on cake microstructure will be discussed
Graham Magill, Engineer I, Pharmaceutical Processing and
Technology 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 from
product 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 solid
therapeutics
• 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 proteins
Jamie 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 FOR
2015
PART
TWO!
Official
Media Partner
Supported by

4. HALF-DAY POST-CONFERENCE AM WORKSHOP
Friday 1st May 2015
8.30am - 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 has
been implemented in many manufacturing
settings and across a broad range of industrial
sectors. Its application is ever widening to cover a
large number of processes that may previously
have been considered to be outside its remit or
grasp. In recent years, the application of the
QbD approach to freeze-drying has been the
subject of a small number of published studies,
although there is arguably a long way to go
before Best Practice can be agreed and opinions
harmonized.
This half-day Workshop on QbD in Lyophilization will
cover a number of aspects of the QbD approach
and how it might be successfully applied to the
freeze-drying process, as well as upstream
activities (formulation, filling, loading) and post-
drying issues.
Why attend this workshop:
Delivered as a combination of short presentations
on QbD concepts and case studies, interspersed
with discussion sessions and small groupwork
exercises, the Workshop is designed to be an
interactive session where participants are also
invited to share their views and experiences with
fellow attendees to gain maximum value from the
session.
Programme
8.30 Registration and Coffee
9.00 Introduction and Opening Remarks
9.10 Can the QbD approach be applied to
formulation and cycle development as an
integrated process?
9.50 How can the different risks arising within
the freezing and drying stages of the
process be assessed/accommodated?
10.30 Coffee Break
11.00 Is it possible to find a good balance of
desktop studies and practical freeze-drying
that won’t be unnecessarily onerous?
11.40 What level of detail should we go to in
assessing the risk and generating
supporting 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 providing
freeze-drying services and training to the
pharmaceutical, diagnostics and biotech
sectors. Following a BSc in Chemistry and a PhD in
pharmaceutical freeze-drying, Kevin joined BTL in
2000. Since then, he and his team have helped
more than 400 companies worldwide, been
involved in the development of over 1000
products, 2 analytical instruments, and trained
more than 2500 people. Kevin publishes and
lectures internationally lyophilisation and the
analytical- and product- related issues associated
with the technology. He is also a Fellow of the
Royal Society of Chemistry.

5. SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and
branding packages, uniquely tailored to complement
your company’s marketing strategy.
Prime networking opportunities exist to entertain,
enhance and expand your client base within the context
of an independent discussion specific to your industry.
Should you wish to join the increasing number of
companies benefiting from sponsoring our
conferences please call: Alia Malick on
+44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
As a leading manufacturer of complete thermal validation
solutions, Ellab is devoted to increase consumer safety by
providing accurate and reliable measurement products.
Ellab’s solutions measure, record, monitor, and validate
critical parameters of thermal processing in the
pharmaceutical and biotech industries. www.ellab.com
Hospira’sOne2One™businessisaleadingglobalinjectable
product CMO. With more than 25 years of experience in
biologic and small molecule fill & finish manufacturing, in-
depth knowledge of lyophilization process, and expertise in
multiple drug delivery technologies, One 2 One™ is a
reliable partner to help achieve customer development
and commercialization goals. http://one2onecmo.com
Experience Since 1957 ~ Freeze Drying is Our Focus Millrock
Technology is always looking to provide new innovations to
the freeze drying industry. Innovation leaders are those who
are either able to better understand customer requirements
and exploit new market opportunities, or access new
technologies to deliver successful new products and
services. As an innovator, Millrock Technology listens to the
needs of the market, while providing value in our product
line. We offer cutting-edge technologies and optimized
methodsoffreezedrying.MillrockTechnologymanufactures
SERIOUS freeze dryers, customized for the
pharmaceutical/biotech marketplace. We focus on one
technology and one market to best satisfy our customers’
needs. www.millrocktech.com
SPScientific,leadersinfreezedryinginnovation,invitesyouto
speak with a representative to learn more about how
ControLyo™ Technology, available for pilot to production
scale 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 New
Jerseyfrom29thto30thApril2015.Pleasecometoourbooth
on 2nd floor and discuss with us about new technologies
and procedures in the freeze drying area. Our product
TEMPRIS® is designed to help customers to reduce
production cost by supporting lyocycle development,
scale-up and transfer. Thus TEMPRIS® enhances the
implementation of new validation concepts, helps to assure
GMP Compliance under cost pressure and in the end
provides overall savings in pharmaceutical production.
TEMPRIS® is already recognized as an interesting PAT tool
and will certainly continue to grow in importance. We look
forward to welcoming you in New Jersey and responding to
your specific demand. www.iqmobil.com
Parenteral Contract Manufacturing Service of Hospira
Lyophilisation and Freeze
Drying USA 2015
Sponsored by

6. FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711
POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor
South, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK
LYOPHILISATION AND FREEZE DRYING USA
Conference: Wednesday 29th & Thursday 30th April 2015, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA Workshops: Friday 1st May 2015, USA
4 WAYS TO REGISTER
www.lyophilisation-usa.com
If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email events@smi-online.co.uk
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