24-25 january 2012 focus day: 23 january 2012 … · investigating lyophilization-related phenomena...
TRANSCRIPT
Your 2012 expert
speaker panel
includes…
Ingo Presser , Head of
Production - Aseptic
Fil ling and Freeze
Drying, Boehringer
Ingelheim
Heiko Schiffter, Lecturer in
Engineering Science (Drug
and Vaccine Delivery),
Institute of Biomedical
Engineering, Department of
Engineering Science,
University of Oxford
Yves Mayeresse, Senior
Freeze-Drying Manager,
GSK Biologicals
Jörg Lümkemann, Resp.
Implementation New
Technologies, Parenterals,
F.Hoffmann-La Roche
Harald Beese, Chemical
Surface and Reaction
Technology, Fraunhofer
Institute for Material and
Beam Technology – IWS
Gerhard Schilder ,
Business Development
Manager, Hof
Sonderanlagenbau
GmbH
Tudor Arvinte,
Professor of
Pharmaceutical &
Biopharmaceuticals,
University of Geneva
Rim Daoussi , Senior
Research Scientist,
VMRD Department,
Pfizer Global Supply
Jean-Pierre Amorij ,
Program Manager
Vaccine Technology,
Vaccinology
Formulation and
Analytical Research,
Netherlands Vaccine
Institute (RIVM)
24-25 JANUARY 2012
FOCUS DAY: 23 JANUARY 2012
MUNICH, GERMANY
www.lyophilizationevent.com
10 REASONS TO ATTEND
1. Hear from 20+ leading industry experts
2. Learn how to successfully scale up your
lyophilization processes
3. Understand the importance of
homogeneity and how to achieve it
4. Learn about using TDLAS to control your
freeze-drying processes
5. Apply QbD and PAT methods to your
organisation’s lyophilization strategies
6. Discuss formulation and its importance in
improving your lyophilized products
7. Assess the applicability of alternate
delivery methods (like pre-filled dual-
chamber syringes and needle-free
injections) to your products
8. Explore the efficacy of nucleation
techniques
9. Survey available thermal analysis
methodologies
10. Ensure regulatory compliance
PHARMA IQ’S 2ND
LYOPHILIZATION FOR
BIOLOGICALS… has been designed specifically to
address some of the most
pressing challenges and exciting
developments from both
academia and the biopharma
industry, including issues of scale-
up, use of innovative technologies
like spray freeze drying and laser
spectroscopy and the application
of proven methodologies like PAT
and QbD. The conference also
features a focus day devoted to
the exploration of alternate
delivery methods like dual-
cartridge pre-filled syringes and
needle-free injections.
Pre-Conference Focus Day: 23rd January 2012
Alternative Delivery Methods 9.00 Registration and Coffee
9.30 Chairperson’s Welcome and Opening Address
9.40 Assessing the Uses for Double-Chamber Pre-Filled Syringes
Understanding the logistics of dual-chamber pre-filled syringes
Assessing the benefits and drawbacks of using this delivery method
Ascertaining which products are most conducive to this delivery method Ingo Presser, Head of Production - Aseptic Filling and Freeze Drying, Boehringer
Ingelheim Pharma GmbH & Co.
10.20 The Use of Drying Methods for Vaccine Delivery
Investigating techniques for needle-free delivery
Developing vaccine formulation and best form factors
Challenges and opportunities of utilising needle-free delivery methods Jean-Pierre Amorij, Program Manager Vaccine Technology, Vaccinology
Formulation and Analytical Research, Netherlands Vaccine Institute (RIVM)
11.00 Networking Coffee Break
11.30 Panel Discussion: Assessing the Applicability of Spray Freeze Drying
Applying the lessons learned by the food industry, where spray freeze drying is widely used
Considering the utility of this technology, particularly as it pertains to large quantities of product
Weighing the drawbacks of spray freeze drying, including potential harm to product
Panellists:
Heiko Schiffter, Lecturer in Engineering Science (Drug and Vaccine Delivery),
Institute of Biomedical Engineering, Department of Engineering Science, University
of Oxford
12.10 Technology Spotlight: Dual-Chamber Syringes Learn about the technology involved in lyophilizing for double-chamber syringes from a solution provider perspective This session is reserved for a leading provider of double-chamber syringe technology. If you think your product would be of interest to the delegation, get in touch on +44 207 368 9300 or email [email protected].
12.50 Group Therapy Lunch
Delivery Dilemmas: Which Delivery Method (and When)?
This session is designed to help increase dialogue and knowledge transfer
between leading industry experts, solution providers and end users. To facilitate
this lunchtime learning, the session leader will begin with a few suggestions of
challenges related to choosing a delivery method and open the discussion to the
audience. The “group therapy” learning format opens the lines of communication
and is designed for speakers, delegates and service providers alike.
Please come prepared to discuss your greatest challenges and share your success s
in the ongoing debate between container form factors and appropriate delivery
methods.
Session Leader: Ingo Presser, Head of Production - Aseptic Filling and Freeze Drying, Boehringer Ingelheim Pharma GmbH & Co.
Pre-Conference Workshop: 23rd January 2012
Workshop – 14.00 – 17.00
The Beginner’s Guide to Lyophilization
In this session, Boehringer-Ingelheim’s Patrick Garidel will lead you through the steps you need to
consider prior to introducing lyophilization in your facility, including:
Requirements you are looking to fulfil by implementing lyophilization
Protocols to put in place in advance of implementation
Surveying the available lyophilization solutions
Training personnel at your facility
Workshop Leader:
Patrick Garidel, Associate Director Protein Science, Boehringer Ingelheim
Conference Day One: 24th January 2012 8.30
Registration and Coffee
9.00 Chairperson’s Welcome and Opening Address
9.10 The Importance of Lyophilization: An Overview
Short introduction to the lyophilization process
Lyophilized market products
Biologics in the dry state: what to consider?
Formulation principles for lyophilized products
Process development of lyophilized products
Primary packaging for lyophilized products
Analytics for the characterisation of lyophilizates
Stability issues Patrick Garidel, Associate Director Protein Science, Boehringer Ingelheim
9.50 The Importance of Formulation in Developing a Stable Lyophilized Product
Utilising high-throughput screening (HTS) to optimise both solutions and processes
Developing lyophilized product that remains stable at room temperature
Promoting homogeneity and maintaining the properties of lyophilized materials
Tudor Arvinte, Professor of Pharmaceutical & Biopharmaceuticals, University of
Geneva
10.30 Networking Coffee Break
11.00 Combined FTIR Chemical Imaging and Freeze-Drying Microscopy for Protein Formulation Development
Understanding how freeze-drying microscopy and FTIR spectroscopy can be combined to investigate in situ the behavior of proteins during cooling, freezing and drying
Applying FTIR chemical imaging to monitor the two-dimensional behavior of proteins and excipients during freeze-drying
Investigating lyophilization-related phenomena such as protein adsorption to interfaces or phase separation using FTIR chemical imaging
Showing the application of the analytical technique to the formulation development of industrially relevant proteins
Heiko Schiffter, Lecturer in Engineering Science (Drug and Vaccine Delivery),
Institute of Biomedical Engineering, Department of Engineering Science, University
of Oxford
11.40 SPEED NETWORKING Like Speed Dating, But Without the Pressure to Commit You’ve seen each other across the room…now meet face-to-face. Bring plenty of business cards to exchange in a series of 2-3 minute one-on-one meetings with your fellow speakers, attendees and vendors. Your mission - learn one of the following things about each person you meet:
1. What do you hope to learn from this conference? 2. Which company/speaker are you most interested in hearing from? 3. What is your biggest challenge in the lyophilization arena?
12.10 Advancements in the Design of Large-Scale Freeze Drying Systems
System design and process optimization
PAT integration
Design trends in refrigeration and vacuum systems
Product protection and loading/unloading activities Gerhard Schilder, Business Development Manager, Hof Sonderanlagenbau GmbH
12.50 Networking Lunch Break
14.00 Examining a Model-Based Framework for Recipe Design and Optimization
Using a mathematical model to get the design space for a pharmaceuticals freeze-drying process (thus optimising the recipe off-line), and a Model Predictive Control system to get the best recipe in-line
Assessing the benefits and the drawbacks of in-line and off-line optimisation, and their applicability in industrial-scale freeze-dryers
Analysing the robustness of the recipe, as well as the effects of model uncertainty and batch non-uniformity
Extension of these methods to recipe scale-up
Applying model-based tools to secondary drying step Davide Fissore, Assistant Professor, Department of Materials Science and Chemical
Engineering, Politecnico di Torino
14.40 Sponsor Spotlight: Coriolis Pharma
Description pending Michael Wiggenhorn, Managing Director, Coriolis Pharma
15.20 Networking Coffee Break
15.50 Optimising Freeze Drying Cycles with TDLAS (Tunable Diode Laser Absorption Spectroscopy)
Controlling freeze drying cycles – current techniques versus idealised requirements
Understanding the physical basics of TDLAS
Examining “proof of concept” experiments for the TDLAS measurement technique and experiments for cycle control
How to apply the QbD /PAT philosophy to freeze drying with TDLAS Jörg Lümkemann, Resp. Implementation New Technologies, Parenterals,
F.Hoffmann-La Roche
16.30 Monitoring and Controlling Freeze Drying Processes with Laser Spectroscopy
Discussing the advantages of TDLAS for freeze drying applications and the reliability of TDLAS as sensor system
Detecting primary and secondary endpoints
Using TDLAS as a tool for process development and quality control
Developing control strategies on basis of H2O partial pressure
Understanding the correlation to residual moisture and measuring residual moisture by diffuse reflectance spectroscopy
Harald Beese, Chemical Surface and Reaction Technology, Fraunhofer Institute for Material and Beam Technology – IWS
17.10 Use of Thermal Analysis to Identify Critical Transitions Temperatures in the Frozen
and Dried State
Review of available methodologies
Dynamic mechanical analysis to derive glass transition temperatures
Applying glass transition temperatures in formulation development and freeze drying
Paul Matejtschuk, Principal Scientist, NIBSC
17.50 Chairperson’s Closing Remarks and End of Day One
Conference Day Two: 25 February 2012 8.30
Registration and Coffee
9.00 Chairperson’s Welcome and Opening Address
9.10 Successfully Scaling Up the Manufacture of Lyophilized Biologicals
Developing stable formulations that can withstand the pressure of upscaling
Ensuring consistency between the laboratory scale and manufacturing
Maintaining GMP at your facility Yves Mayeresse, Senior Freeze-Drying Manager, GSK Biologicals
9.50 Applying PAT to Your Lyophilization Process
Characterising your systems with a limited number of experiments and standardised procedures
Employing advanced monitoring tools
Predicting changes and evaluating variance in your batch as a function of equipment design and operating conditions
Stefan Schneid, Manager R&D, Syntacoll GmbH
10.30 Networking Coffee Break
11.00 New Insights into Specific Surface Area Analysis of Freeze-Dried Pharmaceuticals
Basic principles of Specific Surface Area measurements (SSA)
Integral role of surface area for the freeze-drying process and influence on the target product quality profile, TPQP
New considerations for sample handling, preparation and subsequent measurement methodology.
Difficulties and pitfalls – some case studies Peter Stärtzel, Freeze Drying Focus Group, Division of Pharmaceutics, University of
Erlangen-Nuremberg
11.40 SPEED NETWORKING Like Speed Dating, But Without the Pressure to Commit You’ve seen each other across the room…now meet face-to-face. Bring plenty of business cards to exchange in a series of 2-3 minute one-on-one meetings with your fellow speakers, attendees and vendors. Your mission - learn one of the following things about each person you meet:
1. What was the most important takeaway from Day One? 2. What was the most surprising thing you learned from the previous day’s
talks? 3. Do you have plans to increase use of lyophilization at your organisation?
And do you plan on applying anything you’ve learned from the conference to your own facility?
12.10 Utilising a QbD Approach with Lyophilization Processes
Applying QbD to formulation development
Investigating the product quality impact of freezing methods
Assessing nucleation methods used at RIVM Paul van Herpen, Freeze-Drying Scientist, Freeze-Drying, Netherlands Vaccine
Institute (RIVM)
12.50 Networking Lunch Break
14.00 Panel Discussion: Exploring the Impact of the Nucleation Process
Discussing the techniques used for nucleation such as ice fogging and depressurization
Assessing the advantages of nucleation
Evaluating the utility of nucleation in scale-up Panellists: Stéphanie Passot, Head of Food Process Engineering and Microbiology, INRA
Yves Mayeresse, Senior Freeze-Drying Manager, GSK Biologicals
14.40 In-Line Raman and NIR Spectroscopic Monitoring of Protein Secondary Structure During Freeze-Drying
In-line probing of protein denaturation and lyoprotection
In-line Raman spectroscopy during freezing
In-line NIR spectroscopy during drying
Thomas De Beer, Professor and Head of PAT, University of Ghent
15.20 Networking Coffee Break
15.50 Optimisation of Freeze Drying Cycles of Commercial Formulations
Identification of mass and heat transfer parameters by using PRA model with a non-instantaneous isolation valve
Investigation of sublimation kinetics by using a microbalance and a gravimetric method
Radiation effect during primary drying at low pressure and temperature Rim Daoussi, Senior Research Scientist, VMRD Department, Pfizer Global Supply
16.30 Freeze Drying for API Requiring Further Processing—Powder Flow Properties
Performing bulk freeze drying for efficiency in the cycle development process
Powder characterisation for good flow and dispensing for vials, capsules or tablets
Formulation design for further processing after lyophilisation Andrew Ingham, Lecturer, Pharmaceutics and Drug Delivery, Aston Pharmacy
School, School of Life and Health Sciences, Aston University
17.10 Chairperson’s Closing Remarks and End of Conference
Who Should Attend? Head of Formulation Director of Research & Development Head of Manufacturing Process Engineering Director Head of QA/QC Senior Scientist Head of Production Professor of Pharmaceuticals/Biopharmaceticals
Pre-Conference Learning Materials We have a host of learning materials that you can get stuck into before the event runs in February in
our online resource library at www.lyophilizationevent.com.
Stay up to date with the latest developments in the world of lyophilization with our series of videos,
podcasts and interviews.
We’ll send you updates but keep checking to see what else is new!
Connect With Us:
@PharmaIQ
Lyophilization for Biologicals (Freeze-Drying)
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Sponsors & Exhibitors
The HOF Company was founded in 1988 and since that time supplying the Pharmaceutical Industry with installations, equipment and services
for its sterile production needs. HOF has a wide expertise in GMP Freeze Drying and Automatic Charging Systems (ACS). A typical scope of supply of a Freeze Drying System comprises the transport to its final site, in-house transport and rigging, Installation/Commissioning and Qualification (IQ/OQ). Further, training and instruction of Operators and the Customers Maintenance Group is provided by the HOF Team during FAT and SAT. www.hof-sonderanlagen.de
Coriolis Pharma is a globally operating independent service provider for research and development of (bio)pharmaceutical drugs
(proteins, peptides, monoclonal antibodies, RNA/DNA etc.) and vaccines. An interdisciplinary team of highly qualified scientists with many years of experience in the development of (bio)pharmaceuticals supported by an expert scientific advisory board provides cutting-edge service and know-how related to the formulation development of biopharmaceuticals. This may involve for example formulation development of (pre-)clinical material through to commercial products, lyophilization processes, stability testing, supply of pre-clinical material, and analytical services using innovative analytical technologies. www.coriolis-pharma.com
Patheon Inc. is a leading global provider of contract development and manufacturing services to the global pharmaceutical industry. The company provides the highest quality products and services to approximately 300 of the world's leading pharmaceutical and biotechnology companies.
Patheon's services range from preclinical development through commercial manufacturing of a full array of dosage forms including parenteral, solid, semi-solid and liquid forms. The company's integrated development and manufacturing network of 10 facilities, eight development centers and one clinical trial packaging facility across North America and Europe, ensures that customer products can be launched with confidence anywhere in the world. www.patheon.com
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Sponsorship Opportunities
Get in touch on [email protected] or +44 (0) 207 368 9300
Pharma IQ’s 2nd Annual Lyophilization for Biologicals conference, which will take place 24th-25th
January 2012 in Munich, Germany, will be attended by key decision makers working in formulation,
process engineering and development, R&D and manufacturing, bringing together buyers and
suppliers together in one place.
Focused and high-level, the event is an excellent platform to initiate new business relationships,
launch a new product or raise your profile amongst new markets.
Sponsorship options are extensive and packages can be tailor-made to suit your individual company
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*There are limited presentations available for service providers, contact us now to ensure your
company is able to utilise this exclusive thought leadership opportunity!
For more information on how you can get involved and what packages are available contact us on
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Lyophilization for Biologicals 2011
Disposable Solutions for Biomanufacturing
Innovation in Pre-Filled Syringes and Injectable Technology
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