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

Special offer: Discounted travel with Lufthansa Lufthansa German Airlines offers a comprehensive global route net-work linking major cities around the world. As an airline partner, Lufthansa offers special prices and conditions to participants, visi-tors, exhibitors and invited guests as well as employees of the Con-tracting Partner and their travel companions. To make a reservation, please click on www.lufthansa.com/event-booking_en and enter the access code DEZAWLD in the "Access to Event Booking" area. This will open an online booking platform that will automatically calculate 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 lufthansa.mobility@dlh.de and providing the access code as a reference.

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 77info-europe@pda.org

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: laufenberg@pda.org

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

Registration Form − Page 1

Register before 18 July 2014 and save up to € 250Your registration is only complete upon filling in and submitting both pages of this form.

1 Event Registration

Your Contact Person is Antje Petzholdt at PDA Europepetzholdt@pda.org

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Conference Pharmaceutical Freeze Drying Technology 16-17 September By 18 July 2014 After 18 July 2014

PDA Member 1345 1495Nonmember (No PDA membership included) 1595 1745Govern./Health Authority/Academic (No PDA membership included) 670 750

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

All Participants (No PDA membership included) 695

Two-Day Training Course Development of a Freeze Drying Process 18-19 September By 18 July 2014 After 18 July 2014

All Participants (No PDA membership included) 1395Conference + Two-Day Training Course16-19 September

PDA Member 2245 2495Nonmember (No PDA membership included) 2495 2745

Please mark here if your company is an exhibitor to this event and you will receive the conference ticket at the spe-cial price of 995 Euro per ticket. No further discounts are applicable with this option (as PDA Membership Discount or Group Ticket discount).

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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: info-europe@pda.org

For exhibition informationplease contact:

Elke von LaufenbergExhibition & Sponsorship ManagerTel: + 49 (0) 33056 - 23 77 14Email: laufenberg@pda.org

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