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TRANSCRIPT
PRE-WORKSHOP 15 Sep | CONFERENCE 16-17 Sep | EXHIBITION 16-17 Sep | TRAINING COURSES 18-19 Sep
16-17 September 2014Crowne Plaza – Le PalaceBrussels | Belgium
The Parenteral Drug Association presents...
https://europe.pda.org/FreezeDrying2014
2014 PDA EuropePharmaceutical
Freeze-DryingTechnology
Training Course ICH Q9: Application
of a Risk-based Approach to Freeze-
Drying Processes
Training Course Development of a Freeze-Drying
Process
Pre-Conference Workshop
Spray-Drying – An Alternative to
Freeze Drying?
Letter from the Chairs
Jörg Lümkemann, PhD Conference CoChair, Roche
Yves Mayeresse, Conference CoChair, GSK
Dear Colleagues,
Freeze-Drying very much is an evolving science, and even if there is no current revo-lution, there is continuous evolution. For this year’s conference, we have once again gathered all the innovations in the field for you.
This year’s presentations will focus on the following:
- Transfer of Product and Contract Manufacturing Organisation (CMO) - Risk Analysis for Lyophylization- China’s decision-making process for buying products- Trend towards Green Freeze-Drying- Retro-fitting of an existing facility
More topics will be added during this two-day meeting, drawing from the extensive experience provided by experts coming from various parts of the industry. As usual, the conference will be a great opportunity for in-depth discussion and networking.
In addition, a renowned training course on the Freeze-Drying process and a workshop on the application of risk-based principles will be provided.
We look forward to welcoming you to Brussels and an interesting week of events!
With best regards
3https://europe.pda.org/FreezeDrying2014
Information
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Scientific Planning CommitteeJörg Lümkemann, Co-Chair, RocheYves Mayeresse, Co-Chair, GSK BiologicalsGeorg Frinke, CilagHans Hörmann, Boehringer IngelheimHarald Stahl, GEA PharmaMichele Arduini, IMA LifeGeorg Roessling, PDA EuropeMelanie Decker, PDA Europe
Who Should AttendAreasAPI Development & Production | Pharmaceutical Devel-opment and Production | Process Engineering | Process Development | QC & QA | Container Development Quality Control Production/Manufacturing | Information Technology/Information Systems | Project/Facility Engineering | Manufacturing Process/Packaging Marketing/Sales | Consulting DepartmentsDevelopment | Quality Assurance Manufacturing EngineeringJob FunctionDevelopment | Quality | Manufacturing | Engineering Business Development
VenueCrowne Plaza Brussels – Le PalaceRue Gineste 3, 1210 BrusselsBelgiumT: +32 2 203 62 00F: +32 2 203 55 55Website: www.crowneplazabrussels.be
Special ratesDouble room for single use ¤185**per room per night –including full American breakfast, Wi-Fi Internet access & service charges.
Please note the city tax of Euro 7.00 per night is not included in the rate.
Room ReservationsPDA has secured a limited number of rooms at a special group rate until 1 August 2014. Code word: PDAHousing at the selected hotel will be in high demand, so we strongly recommend making your reservations early.
ContactsFor additional conference information please contact:PDA Europe gGmbHAdalbertstr. 9 16548 Glienicke/ Berlin, GermanyTel: +49 (0) 33056 - 23 77 10 Fax: +49 (0) 33056 - 23 77 [email protected]
To Exhibit:Exhibition and Sponsorship Opportunities are available. PDA meetings and conferences are a great oppor-tunity for your company to gain on-site exposure in front of highly-qualified, upper-level professionals in the pharmaceutical and biopharmaceutical industry. Exhibit at PDA events and let your company’s products or services become a valuable tool or resource for our attendees.
For exhibition information please contact:Elke von LaufenbergExhibition & Sponsorship Manager PDA EuropeTel: +49 (0) 33056 - 23 77 14Email: [email protected]
Mobile Tagging:To go directly to PDA website, simply download any QR Code App and then scan this code with your Smartphone or Tablet.
4
Pre-Conference Workshop
Spray-Drying :An Alternative to Freeze-Drying?
Monday, 15 September 201413:00 Welcome & Introduction
Moderator:Georg Roessling, PDA EuropeJörg Lümkemann, Roche
Session 1 Spray-Drying - Technical Aspects
13:10 The Spray-Drying Process for Formulations
— From a Hardware Perspective — Aseptic Spray-Drying — Review of Key Process Parameters — Influence of Process Parameters on Product Characteristics
Harald Stahl, GEA Pharma Systems
15:00 Coffee Break
Session 2 Spray-Drying - View of a Pharmaceutical Company
15:15 Spray-Drying vs. Freeze-Drying – Pros & Cons:
– General Process
– Costs
– Handling Aspects
What is the Interest of the Pharmaceutical Industry in Spray-Drying?
– Product Design
– Scientific Basics: Peclet Number
– Review of Spray-Dried Pharmaceutical Products
Outlook:
– Spray Granulation
Magdalena Hock, Roche
16:15 Coffee Break
Session 3
16:30 Case Study Richard Johnson, Upperton
17:00 Panel Discussion Jörg Lümkemann, Roche
18:00 End of Workshop
https://europe.pda.org/WSFreeze2014
This interactive workshop with a panel of experts will address the following topics:
— The fundamentals of the Spray-Drying Process including process parameters, product throughput, product yield, suit-ability for temperature labile products, its microbial issues, equipment, machines and much more
— Pros and Cons compared to processes using Freeze-Drying
— The interest of pharmaceutical industry in Spray-Drying - Product Design
— Spray Granulation
— Case Studies on Spray-Drying
All process steps will be considered, from preparation of the formulation to the final product
5https://europe.pda.org/FreezeDrying2014
Tuesday, 16 September 20149:00 Welcome Georg Roessling,
PDA Europe
09:05 News from the Interest Group Freeze-Drying –Particulate Matter in Freeze-Dried Products
Harald Stahl, GEA Pharma
Session 1: Development & Process Transfer Moderator: Georg Frinke, Cilag
Often, Freeze-Drying processes do not have the optimal Lyo-Cycle. This might lead to long drying times, variability in product quality and problems with upscaling. This session is dedicated to development aspects of the Lyo-Cycle since it is essential in achieving a robust production process. Formulation parameters of the process, the process itself, scalability and process transfer will be the main topics of this session.
09:45 Lyocycle Development: The Journey from Lab Scale to Production Scale
Andrea Weiland, Explicat Pharma
10:15 Coffee Break & Exhibition
10:45 Manufacturing Principles of Freeze-Dried Medical Devices Sophie Declomesnil, Synerlab
11:15 Freeze-Drying of L-Arginine-Based Protein Formulations Peter Staertzel, Gilyos
11:45 Q & A, Discussion
12:00 Lunch & Exhibition
Session 2: Nucleation Moderator: Yves Mayeresse, GSK
In this session, various methods of nucleation will be discussed. Ice nucleation as a relatively new method of Freeze-Drying continues to evolve, the process itself has been refined and first product results are in that increase understanding of this process. We will present novel perspectives and discuss potential benefits of ice nucleation and control, among others.
13:00 Recent Advances of Controlled Nucleation to Improve Lyophilization of Biologics
Thomas Bosch, Coriolis Pharma
13:30 Controlled Nucleation James Searles, Hospira
14:00 Controlled Nucleation in Production Scale GMP Lyophilizer Marc Shon, SP Scientific
14:30 SynchroFreeze Gerhard Schilder, HOF Sonderanlagenbau
15:00 Q & A, Discussion
15:15 Coffee Break & Exhibition
Conference Agenda
6 https://europe.pda.org/FreezeDrying2014
Session 3: Dedicated/Multipurpose Moderator: Joerg Luemkemann, Roche
Tox-aseptic filling of parenterals on multi product equipment is a technically demanding task. This is even more true for freeze-dried products which, in contrast to liquid formulations, may have toxic product residues on the outer surface of the primary container. Breakage and exposure of the environment during transport on the fill-finish equipment or during crimping is another challenge. Two opposing principles, the over-pressure concept for aseptics and the under-pressure concept for protection of the workforce need to be accommodated in one installation. Furthermore, aspects like cross- contamination in case of shared use of equipment, and protection of the HVAC system servicing the equip-ment need special consideration. This session will try to shed a light on several aspects of Freeze Drying highly potent compounds. Industry representatives will share their experiences by presenting several case studies.
15:45 Product Separation for Manufacturing of High Potent Drugs Frank Generotzky, Baxter
16:15 Presentation Title to be Confirmed Christian Zimmer, Roche
16:45 Presentation Title to be Confirmed Frank Lehmann, SKAN
17:15 Containment Systems for Biopharmaceutical Freeze-Drying Chris Cherry, MicroPharm
17:45 Q & A, Discussion
18:00 End of Day 1 & Networking Event
Wednesday, 17 September 2014Special Session: Decision-Making Process Moderator: Harald Stahl,
GEA Pharma
A special presentation coming from China will explain the decision-making process for buying equipment in this country. It’s an interesting point of view to relativize the current classical approach.
08:30 China s Decision-Making Process for Buying Products Mr. Xiaobing Sun, Tasly
Session 4: Components & Application Devices for Freeze-Dried Products
Moderator: Harald Stahl, GEA Pharma
The right choice of components - especially elastomers - is essential for the development of freeze-dried products. In this session, we will present an approach how to select, process and handle the appropriate elastomer formulation. Besides the right choice of components for Freeze-Dried products, it is most important to have an easy-to-use applica-tion system for the doctor and patient. A new application system based on a double chamber concept will be presented. Components, functionality and use of the system will be discussed.
09:00 Selection, Preparation and Storage of Lyophilization Stoppers for Moisture-Sensitive Drug Products
Heike Kofler, West Pharmaceutical Service
09:30 A Novel, 2-Chambered Syringe for Reconstitution and Delivery Gautam Shetty, Unilife
10:00 Coffee Break & Exhibition
Conference Agenda
7https://europe.pda.org/FreezeDrying2014
Session 5: Manufacturing-Risk Assessment for Freeze-Dried Products Dedicated & Multipurpose/Alternative Technologies
Moderator: Yves Mayeresse, GSK
This session will be dedicated to manufacturing topics. The first part will address risk-based approaches applied to Freeze-Drying operations. Two case studies will be presented, one for clinical trial material manufacturing and one for a production line. Strength and weaknesses of the respective operations will be outlined, and measures derived from the risk assessments will help increase process robustness. Another presentation will deal with cleaning concepts of Freeze-Drying equipment, especially when handling highly potent drugs is involved. A presentation of a dynamic Freeze-Drying process for bulk manufacturing of sterile microspheres will be followed by a discussion of the process and quality parameters. Spray-Drying as an alternative to Freeze-Drying, and the results of a feasibility study will be discussed. The session closes with a case study of a vaccine facility retrofit.
10:30 Lyophilization and Risk Analysis Karoline Bechthold-Peters, Roche
11:00 Risk Assessment of a Lyophilization Production Line Oliver Ruetsch, Cilag
11:30 Complexity of Freeze-Drying Equipment from the Perspective of Next-Level Cleaning and SHE Requests for High Potent ADC Operations
Franz Bosshammer, NNE Pharmaplan
12:00 Q & A, Discussion
12:15 Lunch & Exhibition
13:15 Dynamic Freeze-Drying for Bulk Manufacture of Sterile Lyophilized Microspheres – Process and Case Study of Industrial Application
Bernd Luy, Meridion Technologies
13:45 Spray-Drying – A Feasibility Study Magdalena Hock, Roche
14:15 Plant Retrofit of a US Vaccine Facility Thomas Beutler, GEA Yves Mayeresse, GSK
14:45 Q & A, Discussion
15:00 Coffee Break & Exhibition
Session 6: Visual Inspection of Freeze-Dried Products Moderator: Oliver Ruetsch, Cilag
The challenges of visually inspecting freeze-dried products are well known. A new approach using a x-ray technique will be presented in this session, and the potential of particle detection in freeze-dried cakes will be discussed. The session will conclude with a panel discussion on different approaches to Visual Inspection.
15:30 X-Ray Detection of Foreign Particulates in Freeze-Dried Products Chris Heynes, Roche
16:00 Panel Discussion: Visual Inspection-Optical Inspection Before the Freeze-Drying Process
Industry Representatives
16:45 Farewell Remarks & End of Conference
Conference Agenda
8
One-Day Training Course
ICH Q9: Application of a Risk-Based Approach to Freeze-Drying Processes
9:00 Theoretical Part π Brief review of ICH Q9 π Description of Freeze-Drying Technology – The equipment – The process – The product and the primary packaging items – The ancillary function (SIP, CIP) – Aseptic level (automatic loading, people presence)π Tools Presentation – Input / Output parameters – Dependent / Independent parameters – CQA: Critical Quality Attributes – FMEA approach – Examples
10:30 Coffee Break
11:00 Practical Partπ Team rule and organizationπ Part I: Product – Independent parameters linked to formulation – Independent parameters linked to
freeze-dryer loadπ Part II: Process – Independent parameters linked to the
freeze-dryer
12:30 Lunch
14:00 Practical Partπ Part II (continued): Process – Independant parameters that are measured
and controlled during the cycle – Dependent parameters linked to the
freeze-drying cycleπ Part III: Critical attributes linked to
freeze-drying processπ Part IV: Ancillary Function – SIP
15:30 Coffee Break
15:45 Practical Partπ Part IV (continued): Ancillary Function – CIPπ Part V: Aseptic Level
16:30 Conclusions– Q&A– Feedback about the approach
17:00 End of the Course
Agenda subject to change without notice
Thursday, 18 September 2014
Training Course Leader:Yves Mayeresse, GSK Vaccines, BelgiumYves Mayeresse is director of manufacturing expertise for primary and secondary operations by GlaxoSmithKline Vaccines. He has more than twenty years of experience in the pharmaceutical sector and has worked for differ-ent companies. He has managed activities such as parenterals production, set-up of new Freeze-Drying facilities, design of Freeze-Drying cycle and development of new stabilizers for freeze-dried products. Transfer of product towards different internal and external site. He has worked on the industrialization of new freeze-dried products and then in the technical life cycle management. Now he is focussing on support, training and guidance definition for the primary and secondary operations. He is an engineer in biochemistry, he has written articles about Freeze-Drying science and he is a regular speaker for conferences on Freeze-Drying.
Training Course Description:This one-day training course will introduce the concept of Risk Management described in the ICH Q9 and will apply it to the Freeze-Drying process. The first part will review the guidelines, the Freeze-Drying process and the tools available to score the risks. The second part will be fully interactive. Participants will express their views in terms of detectability, occurrence and control of the various risks linked to the Freeze-Drying process. The process will be subdivided into different chapters: Product, Process, Critical Quality Attributes, Ancillary Function of the equipment and Aseptic Level. The day will close with answering questions and with a discussion of the usefulness of this approach.
The training will provide to the participant:• A practical approach to risk management• A deeper understanding of the Freeze-Drying process• Learning from peers during the practical part• A methodology to perform risk management
https://europe.pda.org/ICHQ92014
9
Two-Day Training Course
Development of a Freeze-Drying Process − From Formulation to a Robust Process −Course AgendaThis seminar will give a thorough introduction into the Physics and Thermodynamics of Freeze-Drying. This seminar comes with an additional overview about technical aspects to be considered and gives an overview about current technologies available on the market. It is created to introduce all people who are professionally linked to Freeze-Drying and might be of special interest for cycle developers (R&D), upscale & transfer specialists, project managers & engineers, process & site engineers, quali-fication & validation specialists. Open problem examination allows you to bring in a current problem linked to Freeze-Drying. The group will discuss and evaluate possible approaches for troubleshooting.
8:30 Registration
9:00 Accomodation & Introduction – Introduction into drying technologies – Overview of the Freeze-Drying process – Properties of Water – Properties of Heat Transfer during Lyophilization
10:30 Nucleation – Scientific Basics – Freezing Process – Sensors & PAT
13:00 Lunch
14:00 Sublimation – Scientific Basics – Drying Process – Sensors & PAT – Hands on – Calculation of BTM
16:30 Desorption – Scientific Basics – Residual Moisture – Sensors & PAT
17:30 Open Problem Examination
18:30 End of First Day
Thursday, 18 September 2014 Theory
8:30 Repetition of Previous Day Theory
9:00 Recipe Development
11:30 Module Structure of a Freeze Dryer – Vessel Components (Chamber & Shelf System) – High Purity System – Process Supply System – Sensor Equipment & Electrics
ENGINEERING ASPECTS – Design Criteria – System Benchmarks – Performance Criteria – Installation vs. Process
13:00 Lunch
14:00 Process & System Engineering – Common Technologies for PAT control – Example for a Mini-Pilot – Turn-Around
15:00 Conducting a Lyo into Production – Hints for the SAT – Qualification – ΩΩ
16:30 Chilling End Samples of Collapsed Probes – Attempting Troubleshooting
17:00 Summary and End of Training
Friday, 19 September 2014 Technologies & Practice
Faculty:Georg Frinke, CILAG AGGeorg holds a degree in Engineering from UAS, Cologne, Germany. He is Process Engineer at CILAG AG Schaffhausen and responsible for the technical operation of the R&D production systems at the small-scale facility F2P2. Previously, he worked as Process Engineer for Optima (Klee) and GEA Lyophil / Steris. Among others he is specialized in the development of customized Freeze-Drying processes (particularly upscaling with PAT) and in the qualification (FAT, SAT, IQ, OQ, PQ) of pharmaceutical freeze dryers.
Frequent breaks for coffee and refreshments included
https://europe.pda.org/TCFreezeDrying2014
2014 PDA Europe Pre-Workshop, Conference, Exhibition, Training Courses
Pharmaceutical Freeze Drying Technology16-17 September 2014 | Brussels | Belgium
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Conference Pharmaceutical Freeze Drying Technology 16-17 September By 18 July 2014 After 18 July 2014
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Pre-Conference WorkshopSpray-Drying – An Alternative to Freeze Drying? 15 SeptemberAll Participants (No PDA membership included) 495
One-Day Training CourseICH Q9: Application of a Risk-based Approach to Freeze Drying Processes 18 September
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Two-Day Training Course Development of a Freeze Drying Process 18-19 September By 18 July 2014 After 18 July 2014
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ONLINE: https://europe.pda.org/FreezeDrying2014 FAX: +49 33056 23 77 77EMAIL: [email protected] MAIL: PDA Europe, Adalbertstr. 9, 16548 Glienicke/Berlin, Germany
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2014 PDA Europe Pre-Workshop, Conference, Exhibition, Training CoursesPharmaceutical Freeze Drying Technology16-17 September | Brussels | Belgium
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PDA Europe Upcoming Activities and Events
Get a quick survey of all PDA Europe activities with the myPDA-WebApp.For Apple iPhone & iPad, Android and Windows Mobile7 smartphones: www.my-pda.eu
Additional training courses will accompany most conferences. For details, please use the CR-Code or got to www.europe.pda.org
For general informationplease contact:
PDA Europe, Adalbertstr. 916548 Glienicke / Berlin, GermanyTel: +49 (0) 33056 - 23 77 10Fax: +49 (0) 33056 - 23 77 77Email: [email protected]
For exhibition informationplease contact:
Elke von LaufenbergExhibition & Sponsorship ManagerTel: + 49 (0) 33056 - 23 77 14Email: [email protected]
2014
15-19 SeptemberPre-conference Workshop, Conference, Exhibition, Training Courses
Pharmaceutical Freeze-Drying Technology
Brussels Belgium
18-19 September Training Course PDA/PICs API Training CourseBrussels Belgium
22-25 SeptemberPre-Workshop, Workshop, Exhibition, Training Courses
7th Workshop on Monoclonal Antibodies
Basel Switzerland
29 September –1 October
Conference, Exhibition, Training Course MycoplasmaBerlinGermany
14-17 October Conference, Exhibition, Training CoursePharmaceutical Cold & Supply Chain Logistics
BerlinGermany
21-24 October Conference, Exhibition, Training Course Visual Inspection ForumBerlinGermany
4-7 November Conference, Exhibition, Training Courses ParenteralsMunichGermany
2-4 December Conference, Exhibition, Training Course Outsourcing/Contract ManufacturingBerlinGermany
For latest info: europe.pda.org Subject to change Shortlist 2014-05-21