2016 PDA Europe Pharmaceutical Freeze Drying Technology The Parenteral Drug Association presents: pda.org/EU/FreezeDrying2016 Gold Sponsor Validation Solutions 27-28 September 2016 Hilton Strasbourg Strasbourg | France 27-28 September | Conference Pharmaceutical Freeze Drying Technology 29 September | Training Course Application of a Risk-Based Approach to Freeze Drying Processes 29-30 September | Workshop Development of a Freeze Drying Process
16
Embed
Pharmaceutical Freeze Drying Technology - IMA Group PDA Europe Pharmaceutical Freeze Drying Technology The Parenteral Drug Association presents: pda.org/EU/FreezeDrying2016 Gold Sponsor
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
2016 PDA Europe Pharmaceutical Freeze Drying Technology
The Parenteral Drug Association presents:
pda.org/EU/FreezeDrying2016
Gold Sponsor
Validation Solutions
27-28 September 2016 Hilton Strasbourg
Strasbourg | France
Register by 27 Aug 2016 and SAVE!
27-28 September | ConferencePharmaceutical Freeze Drying Technology
29 September | Training CourseApplication of a Risk-Based Approach to
Freeze Drying Processes
29-30 September | WorkshopDevelopment of a Freeze Drying Process
PDA Europe and the Scientific Program Planning Committee warmly welcome you to the 10th Anniversary of the Pharmaceutical Freeze Drying Technology Conference!
This year, we will meet in Strasbourg/France, 27-28 September 2016 to again share with you updates of various technical and regulatory aspects regarding the complex freeze drying process, and to celebrate the achievements of collaborating in this format for the past ten years!
Since the beginning of this meeting, freeze-drying of biopharmaceuticals has become a routine procedure, leading to an increase in product stability and reaching acceptable shelf lives that benefit patients worldwide.
We believe to have significantly contributed to this progress by offering discourse and bringing together a group of highly qualified and diverse professionals every year.
This year again, our colleagues have worked hard to facilitate a broad science-based discussion of the matter with contributions from pharma industry, manufacturers and regulatory agencies. Regular attendees of this event have gained detailed process knowledge and insights throughout these past ten years, and we are very proud to once again share current and novel concepts such as spray freeze drying, ice-fog nucleation and automated loading/unloading schemes.
Due to the friendly yet professional atmosphere, and with many opportunities for connecting with experts and fellow attendees, business leads have resulted in several fruitful collaborations be-tween pharma and solution providers. The idea for reliable silicone oil detection, for example, was born during such a coffee break when discussions were continued beyond the conference room.
We believe that this event has contributed to the advancement of the Freeze Drying process as a science overall, and we encourage you to get involved!
PDA Europe offers the perfect opportunity to evolve from an attendee to a speaker to a committee member, like we as today’s Conference Chairs have done, thereby supporting your personal and professional development and career paths!
Let’s meet in Strasbourg! We look forward to welcoming you to the PDA Europe Pharmaceutical Freeze Drying Technology Conference!
Session 1: Current Manufacturing Topics Moderator: Ingo Presser, Boehringer Ingelheim
Although it is one of the oldest techniques in the pharmaceutical industry for the preservation of unstable materials, there still is an increased demand for lyophilized products and equipment. To accommodate such a growth, the freeze-drying process requires an increased process control, an acceleration of the processing time and upgrades in equipment to remain compliant with changing regulatory requirements. The aim of this session is to provide a better understanding of good lyophilization practices and evolutions to keep freeze-drying competitive as a pharmaceutical processing step.
9:10 Manufacturing Practices - Interfaces Thomas Hense, Baxter
9:40 Case Study on the Evolution, Upgrade and Performance of a Lyo Plant with the Aim to Achieve 100 % Green Alternative
Christophe de St Leger, IMA Life
10:10 New Processes for Freeze-Drying in Dual Chamber Systems Tobias Werk, Roche
10:40 Q & A, Discussion
10:50 Coffee Break, Poster Session & Exhibition
Session 2: Process Control Moderator: Michele Arduini, IMA Life
Freeze drying is a process that is always running on the edge of what is feasible from a process, product and equipment perspective. Thisis given by the simple fact that thermodynamics demand it to run like this. Control of all relevant input parameters like vacuum and shelf temperature, and close monitoring of the process are of utmost importance. Modern techniques give better access and control of thefreeze drying process. This session will shed light on these techniques.
11:20 Continuous Development of PAT Tools to Better Understand the Freeze Drying Process Cycle
Arnab Ganguly, IMA Life
11:40 The Challenge of Accurate Pressure Monitoring Daniel Kuchenbecker, Pfeiffer Vacuum
12:10 Lunch Break, Poster Session & Exhibition
13:10 Impact of Temperature Edge Effects on Water Content in Freeze Dried Finished Product
Jesper Davidson, Novo Nordisk
13:40 Evaluation of Heat Flux Measurements and Headspace Moisture Analysis for Lyophilization Process, Product, and Equipment Characterization
Thomas Bosch, Coriolis Pharma
14:10 Q & A, Discussion
14:30 Coffee Break and Cutting of the 10th Anniversary Cake
Session 3: Quality by Design, Process Analytics Technology Moderator: Raf De Dier, Janssen
‘Process analytical technology’ and ‘Quality by Design’ have become topics of routine discussion in the pharmaceutical industry. Yet, many are finding it difficult to implement these tools and techniques into the daily production area and provide confidence that quality indeed is designed in - and risk reduced. In this session, we will go beyond the basic principles of PAT & QbD serving those who require a more integrated approach to these initiatives. Focus will be placed on reports of implementation and case studies from companies, the development of new procedures as well as new trends in sensor technology in freeze-drying.
15:00 The Application of Through Vial Impedance Spectroscopy for Process Parameter Determination in Freeze-Drying Method Development
Geoff Smith, De Montfort University
15:30 Transfer of a Legacy Product between two Sites: How to Increase Process Knowledge Leading to Process Improvement
Erwan Bourles & Benoit A. Moreau, GlaxoSmithKline
16:00 Increasing Confidence in Lyophilization QbD: Integration of Pre-process, In-process and Post-process Analytics
Container closure integrity for freeze-dried products becomes a topic of increased interest, due to a difficult detectability of cracks at visual inspection steps following the presence of a cake inside the vial. Different technologies performing 100% detection are available on the market .During this session, after a short introduction, detection methods will be reviewed and applied to case studies. The aim is to provide the audience a good understanding of the advantages and limitation of the available technology existing on the market.
17:15 Introduction to CCI Testing for Freeze-Dried Products Yves Mayeresse, GlaxoSmithKline Vaccines
17:35 Laser-based Headspace for CCIT of Lyo Product During the Full Product Life Cycle
Derek Duncan, LIGHTHOUSE
17:55 Total Quality on Lyo Containers Roland Koch, Wilco
18:15 State-of-the-Art 100 % Container Closure Integrity Testing and Headspace Gas Verification: An Integrated Approach for Freeze Dried Parenteral Products. Insights, Rationales and Findings from a Case Study
9:00 Continuous Freeze Drying of Parenteral Vials:A Promising Outlook on Available Technologies
Georg Frinke, Bayer Pharma
10:00 Q & A, Discussion
Session 5: Trends & New Concepts Moderator: Joerg Luemkemann, Roche
Freeze drying is increasingly better understood from a scientific perspective. We gain deeper understanding not only about the fundamental physics of this unit operation, but we can better and better understand the complex aspects that lead to success or failure during the lyophilization process. We start to use this in-depth knowledge to make freeze drying faster, safer, cheaper, or more compatible with patients’ needs. This session will give an overview about some initiatives in this context.
10:15 How to Manage Scale-up Using Design Space Approach Bernadette Scutella, GlaxoSmithKline
10:45 Freeze Dryer Equipment Limit Characterization: Eliminating Trial-and-Error in Scale-up
Arnab Ganguly, IMA Life
11:15 Coffee Break, Poster Session & Exhibition
11:45 Bulk Lyophilization of Microspheres in an Industrial Scale Matthias Plitzko, Meridion Technologies
12:15 Freeze Drying using New Technology Stéphane Guillaud, ellab
12:45 Comparison of the In-Vitro Release Characteristics of Freeze Dried Biomatrix Containing an Soluble Drug
Application of a Risk-Based Approach to Freeze-Drying Processes
ONE-DAY TRAINING COURSE
Who Should Attend:
This course is designed specifically for people having an interest in freeze-drying. The audience can come from the various horizons of people performing technical risk assessment, including, but not limited to: production, quality assurance, validation, engineering and develop-ment specialist.
Learning Objectives:
Upon completion of this course, the attendee will be able to:
• Better understand the freeze-drying process explained through the different examples
• Master ICH Q9 approach in term of risk based approach
• Recognize a critical parameters for a process
• Score the criticality of a parameters
• Work in team by reaching consensus around criticality levels
OverviewOne master piece of current process validation approach is risk analysis. It allows defining and measuring the critical parameters of the process for which a specific level of scrutiny is necessary in order to end-up with a robust process under control. The objective of this course is to give an understanding of risk management through ICHQ9 applied 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 session will be subdivided into different chapters: Product, Process, Critical Quality Attributes, Ancillary Function of the equipment and Aseptic Level. The different tools to perform risk analysis will be described and the main focus will be on an FMEA (Failure Mode and Effects Analysis) approach. The output of the workshop is a table consisting of the different parameters with their associated level of criticality that will be shared with the participant
Yves Mayeresse, GlaxoSmithKline Vaccines
Yves Mayeresse is director in manufacturing technology inside MSAT by GlaxoSmithKline Vaccines. He has more than twenty years of experience in the pharmaceutical sector and has worked for different companies. Yves 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 to-wards different internal and external site. He has worked on the industrialization of new freeze-dried prod-
ucts and then in the technical life cycle management. Now Yves is focusing on different technologies used 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.
9:00 Theoretical Part ▶ Brief review of ICH Q9 ▶ 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)▶ Tools Presentation – Input / Output parameters – Dependent / Independent parameters – CQA: Critical Quality Attributes – FMEA approach – Examples
10:30 Coffee Break
11:00 Practical Part▶ Team rule and organization▶ Part I: Product – Independent parameters linked to formulation – Independent parameters linked to freeze-dryer load▶ Part II: Process – Independent parameters linked to the freeze-dryer
12:30 Lunch
14:00 Practical Part▶ Part II (continued): Process – Independet parameters that are measured and controlled during the cycle – Dependent parameters linked to the freeze-drying cycle▶ Part III: Critical attributes linked to freeze-drying process▶ Part IV: Ancillary Function – SIP
15:30 Coffee Break
15:45 Practical Part▶ Part IV (continued): Ancillary Function – CIP▶ Part V: Aseptic Level
16:30 Conclusions• – Q&A• – Feedback about the approach
Development of a Freeze-Drying ProcessOverviewThis workshop 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 creat-ed 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, qualification & 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.
Georg Frinke, Bayer Pharma
Georg holds a degree in Engineering from UAS, Cologne, Germany. He is Process Engineer at Bayer Pharma and responsible for the technical operation of the parenteral facility. Previously, he worked as Process Engi-neer for Optima (Klee) and GEA Lyophil / Steris. Among others he is specialized in the development of custom-ized Freeze-Drying processes (particularly upscaling with PAT) and in the qualification (FAT, SAT, IQ, OQ, PQ) of pharmaceutical freeze dryers.
TWO-DAY WORKSHOP
Who Should Attend:
• Cycle Developers (R&D)
• Upscale & Transfer Specialists
• Project Managers & Engineers
• Process & Site Engineers
• Qualification & Validation Specialists
• Members of Parenteral Production Teams
Learning Objectives:
Upon completion of this course participants will know the basic principles of all Freeze Drying aspects:
• Physical/Thermodynamic Theory of Nucleation, Subli-mation and Desorption
• Technical & Technological Solutions to accomplish a standard process
• Based on the prior theory, several Hands-on-sessions provide practical knowledge to design a freeze-drying process
9:00 Introduction• Introduction into Drying Technologies• Overview of the Freeze Drying Process• Properties of Water• Properties of Heat Transfer during
Bring in your Questions:Real problems of Freeze Drying can be presented and will be discussed as a group
18:30 End of Day 1
Friday, 30 September 2016 8:30 – 17:00
TECHN O LO G IE S & PR AC TI CE
8:30 Repetition of Previous Day Theory & Transfer of a Freeze Drying Cycle
9:00 Hands-On: Recipe Development
11:00 Coffee Break
11:30 Module Structure of a Freeze Dryer• Chamber & Shelf System• Condenser & Main Valve• Venting System / Filter Test• Refrigeration• Vacuum System• CIP / SIP Systems
12:30 Lunch Break
14:00 Module Structure of a Freeze Dryer (Cont.)• System Benchmarks• Performance Criteria• Installation vs. Process• Design Criteria & Engineering Aspects
15:00 Coffee Break
15:30 Hands-on: • Evaluation of the Lyo experiment & samples
G E N E R A L A D D R E S SPDA Europe gGmbH Am Borsigturm 60 13507 Berlin, Germany Tel: +49 30 4365508-0 Fax: +49 30 4365508-66
CO N F E R E N C E R EG I S TR ATI O N H O U R STuesday, 27 September: 8:00h – 16:00h Wednesday, 28 September: 8:00h – 12:00hCO U R S E R EG I S TR ATI O N H O U R SThursday, 29 September: 7:30h – 16:00h
TO E X H I B ITExhibition and Sponsorship Opportunities are available. PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of high-ly-qualified, upper-level professionals in the pharmaceuti-cal and biopharmaceutical industry. Exhibit at PDA events and let your company’s products or services become a valuable tool or resource for our attendees.
S PEC I A L R EQU I R E M E NT SIf you require special accommodations to fully par- ticipate, please attach a written description of your
needs with your registration form. Specific questions can be directed to [email protected].
INFORMATION
Special offer: Discounted travel with Lufthansa Group Airlines
Lufthansa Group Par tner Airlines of fer a comprehensive global route network linking major cities around the world. We offer spe-cial prices and conditions to par ticipants, visitors, exhibitors, in-vited guests as well as employees of the Contracting par tner and their travel companions. To make a reser vation, please click on www.lufthansa.com/event-booking_en and enter the access code DEZZYGH in the "Access to Your Special Lufthansa Offer" area. This will open an online booking platform that will automatically calcu-late the discount offered or provide you with an even better offer if another promotional fare is available.
NOTE: Pop-ups must be enabled otherwise the booking platform window will not open.
These promotional fares are also available through your IATA / ARC travel agent. Travel agents can obtain ticketing instructions by send-ing an email to [email protected] and providing the access code as a reference.
If this form is an update to a previously submitted form, please check here.
Mr. Ms. Dr. NonmemberI want to become a PDA Member. Please send me a subsription form
Job Title *
Mailing Address
Substituting for(Ch e ck only i f you are subs t i tut ing for a pre v iously e nrolle d colleag ue; a nonme mb e r subs t i tut ing for me mb e r mus t pay t h e me mb e r ship fe e.)
* This information will be published in the conference attendee list. Should you not wish us to publish these details, please contact us.
1 Your Contact Information
PDA MemberName (Last, First, MI) *
ID Number
Country Email *
FaxBusiness Phone
Company* Department
City Postal Code
CONFIRMATION: Transmitting your filled-in registration form constitutes a binding application for the specific event. PDA Europe will send you a confirmation including payment details. A legally binding contract is concluded once PDA Europe has sent a written invoice by mail to you. You must have a written confirmation (including invoice) to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. Payment must be received or guaranteed by Purchase Order or credit card details on 1st day of event, at the very latest. SUBSTITUTIONS: If you are unable to attend, substitutions are welcome and can be made at any time, including on site at the prevailing rate. If you are registering as a substitute attendee, please indicate this on the registration form. Changes are free of charge until 2 weeks prior to the start of the event. After this two-weeks period, there will be a charge of € 100 per name change. REFUNDS: Refund requests must be sent to PDA Europe. If your written request is received on or before 27 August 2016, you will receive a full refund minus a 150 € excl. VAT handling fee. After that time, no refund or credit requests will be approved. If you are an unpaid registrant and do not attend the event, you are responsible for paying the registration fee. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. PDA Europe works PCI-Compliant. EVENT CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be canceled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at [email protected] or fax to +49 30 4365508-66. DOCUMENTATION: With your signature you give complete picture usage right to PDA and allow to film your exhibition space and intervention in the event, including the recording of your presentation for video purposes (with your slides, voice and image). This right extends also to the use of the resulting images in film documentation for webinars and similar items produced by PDA.
Discount for Exhibiting Companies Please mark here if your company is an exhibitor to this event and you will receive the conference ticket at the special price of 995 Euro per ticket. No further discounts are applicable with this option (as PDA Membership Discount or Group Ticket discount). This special rate does not include one-year PDA membership.
PDA Europe VAT I.D.: DE254459362
3 Payment Options
Billing Address:
Same as contact information address above. If not, please send your billing address to: [email protected]
Date Mandatory Signature
By Credit Card
American Express MasterCard VISA
For your credit card information safety:Please send your details by fax only (+49 30 4365508-66) or register online.
By Bank Transfer Beneficiary: PDA Europe gGmbHIBAN: DE73 1007 0024 0922 8735 00 BIC (SWIFT-Code): DEUTDEDBBERBank Address: Deutsche Bank, Welfenallee 3-7, D-13465 Berlin, Germany
By Purchase Order Purchase Order Number
The fee includes course documentation as well as mid-session refreshments and lunch. Excellent networking opportunities with snacks and drinks will be given. The fee does not include the hotel accommodation. PDA Europe has secured a limited number of rooms at a special group rate.
Information about Visa Matters • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
• All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for sub-mitting documents by courier.)
• Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
Your Company VAT I.D.:
This number starts by your country code with two characters (example: PDA Europe’s country code starts with: DE | followed by the number)
Pharmaceutical Freeze Drying Technology27-28 September 2016 | Strasbourg | France
All fees given in Euro and excluding VAT (20 %)Conference (27-28 September) netPDA Member 1495Nonmember 1745
Two-Day Workshop (29-30 September)Development of a Freeze Drying ProcessAll Participants 1495
One-Day Training Course (29 September)Application of a Risk-Based Approach to Freeze Drying ProcessesAll Participants 695
2 RegistrationNo PDA membership included
Group Registration Discount Register 5 colleagues for the conference at the same time and receive the 5th registration free. For more information on group discounts please contact us at [email protected]. Other discounts cannot be applied.
This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing.