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www.zeta.com/symposium page 1 INFORMATION & PROGRAM www.zeta.com/symposium March 11-13, 2019 // AUSTRIA SYMPOSIUM

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www.zeta.com/symposiumpage 1

INFORMATION & PROGRAMwww.zeta.com/symposium

March 11-13, 2019 // AUSTRIA

SYMPOSIUM

www.zeta.com/symposiumpage 2

BIOPHARMA EXPERTS MEET AT ZETA SYMPOSIUM 2019

The ZETA Symposium, taking place from March 11-13, 2019 at Schloss Seggau

The overall objectives of the Symposium are:• Creating a platform for business partners for the discussion of relevant issues in

biotech and pharmaceutical industry

• Providing lectures on current and trend-setting topics by experienced professionals and experts

• The symposium shall give you new perspectives, inspiration and insights

• Giving our customers and business partners the possibility to get new inspira-tion, discuss hot topics in the biotech and pharmaceutical industry and get an idea of the facilities of the future

Target Group: • Operational leaders of pharmaceutical companies

• Plant and site managers of pharmaceutical manufacturing sites

• Quality and engineering executives from pharma and biotech

• Suppliers and partners of the pharmaceutical industry

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AGENDA Monday, March 11, 2019

03.00 – 06.00 pm Check in at Seggau Castle

05.00 – 07.00 pm Get-together

07.00 – 10.00 pm Dinner at Seggau Castle

ZETA

Sym

posi

um

11 12 13

Mon Tue Wed

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AGENDA Tuesday, March 12, 2019

SESSION I 08.00 am GoodmorningCoffee

09.00 – 09.15 am Welcome and Opening of ZETA Symposium by Andreas Marchler, Managing Director of ZETA

09.15 – 10.00 am Time to Market: Teaching Pharma Elephants to dance...? Keynote Speaker: Gert Moelgaard, Moelgaard Consulting // Discussion

10.00 – 10.30 am Single Use Technology — Challenges in industrial Scale Production What are the technical and automation Requirements from a User Point of View for successful Operation? Key Speaker: Ken Clapp, Senior Manager, Applications, Technology & Integration at GE Healthcare// Discussion

SESSION II11.00 – 11.30 am Continuous Manufacturing, Transitioning from Batch to Continuous Economics and Operational Implications Key Speaker: Andrew Sinclair, CEO BioPharm // Discussion

11.45 – 12.15 am Establishment of an improved and new 200L Cryovessel -70°C freeze/thaw process in the Focused Factory Drug Substance at Boehringer Ingelheim Key Speaker: Benno Knopf, Executive Director Formulation G104 at Boehringer Ingelheim Pharma // Discussion

12.30 – 02.30 pm Lunch at Schloss Seggau

Product Show

11 12 13

Mon Tue Wed

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AGENDA March, Tuesday 12, 2019

SESSION III02.30 – 03.00 pm Bioprocesses made transparent Stirring on industrial Scale – deep Insights and Characterization Key Speaker: Prof. Michael Schlüter, Hamburg University of Technology // Discussion 03.00 – 03.30 pm The 10 biggest Pitfalls in Engineering and Plant Construction Projects Key Speaker: Alexander Kogler, Centerline Management Consulting // Discussion

SESSION IV04.00 – 04.45 pm Matching both: Pilot Plant and industrial Scale Production in one Line — An innovative Approach of joint Project Planning and Execution Key Speaker: Ernst Metzger, Head of Corporate Pilot Production, Octapharma Vienna and Johannes Koch, Project Manager Engineering, ZETA // Discussion 05.00 – 06.00 pm Panel Discussion “Time-to-market – what have we learned and how can we improve?” Topics of interest by the audience Moderation by Gert Moelgaard

07.00 – 10.00 pm Dinner at Schloss Seggau

Product Show

11 12 13

Mon Tue Wed

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AGENDA March, Wednesday 13, 2019

SESSION I 08.00 am Goodmorningcoffee

08.30 – 09.15 am The LSCC Project — new Large Scale Cell Culture Production Plant in Vienna Key Speaker: Uwe Theobald, Lead Process LSCC Project, Boehringer-Ingelheim RCV // Discussion

09.15 – 09.45 am AParadigmShiftinProjectExecution–arevolutionaryApproachenhanced by fully integrated Tools to shorten Time-to-Market for Biologics Key Speaker: Marie-Astrid Haibl, Head of Process Engineering, ZETA // Discussion

SESSION II10.15 – 10.45 am Key Challenges in Analytical Similarity & Global Regulatory Approvals for Biosimilars Key Speaker: Dipti Rai, Principal Scientific Manager at Biocon, India // Discussion

10.45 – 11.15 am Applying Old Know-How to New Challenges: the Manufacturing of Emerging Therapeutic Modalities Key Speaker: Uwe Gottschalk, Chief Scientific Officer at Lonza // Discussion

Product Show

11 12 13Mon Tue Wed

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AGENDA March, Wednesday 13, 2019

SESSION III

11.45 – 12.15 pm Rapid Decision-Making Using Simulation & Analytics Vision of an adaptive Manufacturing- how Mature is your digital Manufacturing and how can „Advanced Analytics“ help to stay competitive in the Life Sciences Market Key Speaker: Uwe Küppers, Senior Business Development Manager Rockwell Automation // Discussion

12.15 – 12.45 pm PrinciplesofandExamplesforcost-effectiveandTimesaving integratedQualification? Key Speaker: Eva Baumgartner, Validation Manager at Syntacoll // Discussion

01.00 – 02.30 pm Lunch at Schloss Seggau

11 12 13Mon Tue Wed

Product Show

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AGENDA March, Wednesday 13, 2019

02.30 - 03.15 pm Transfer either to ZETA Headquarters in Lieboch or at the premises in Lebring.

During ZETA Symposium the participants will be given the opportunity to participate in two expert workshops! The partici-pation in the workshops may be booked optionally.

03.30 – 05.00 pm Workshop I

“Dead-spot-free and product-contact surfaces – challenges of hygienic design: Whattoexpectfromthenewguidelinesreleasedin2018byASMEforcleardefinitionof cleanability in bioprocess manufacturing“ Int. Welding Engineer Daniel Juritsch, Head of Mechanical Installation at ZETA together with his team will refer on theoretical aspects and the practical consequences arising of the new ASME guidelines; the most relevant examples will be given and discussed. The workshop will be executed on the ZETA premises in Lebring, the number of participants is limited to 20 persons.

03.30 – 05.00 pm Workshop II

“EffectivequalificationbasedonCustomer-SupplierPartnership–howcancustomersbenefit from the new approach? “ Clemens Borkenstein, Head of Executive Quality at ZETA, and his team are showcasing the executionofaconsistentprojectdocumentationbasedonthenewqualificationapproach. The workshop will be executed on the ZETA premises in Lieboch, the number of participants is limited to 20 persons.

06.00 pm End of the ZETA Symposium 2019

11 12 13Mon Tue Wed

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PRODUCT SHOWat Schloss Seggau along the conference with special insights into:

Fast-Track Project Execution Welding Technologies

Freeze & Thaw SystemsDedusting Ring

Action stage: Oxygen Transfer in Fermenters Solution Path ZETA Engineering

Valves, Measurement & Control Systems by Gemü Sensor and measuring Technology by Endress & Hauser

Scales and analytical Instruments by Mettler ToledoTube Systems in Stainless Steel by Dockweiler

HighlyefficientSolutionsforFactoryandProcessAutomationby TurckWelding Technology by Orbitalum

Control Systems by SAMSONBioreactor Design by Bolz

Comprehensive Automation Solutions by Rockwell Pneumatic and electric Drive Technology by FestoWater Treatment Systems by USF Water Purification

COMOS Engineering Tool by Siemens

Learn from experts and get valuable insights into innovative process development and product technology during our two days program! Moreover, take the chance to NETWORK with key industry leaders, DISCOVER business opportunities and PROCURE the technologies, products or services that meet your business needs!

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THE ZETA SYMPOSIUM IS OPEN TO A LIMITED NUMBER OF PARTICIPANTS ONLY!Register online now via the registration form to secure your successful participation!

Early Bird: Registration by January 25, 2019 € 220,–* Deadline: Registration by March 1, 2019 € 280,– *

* The registration fee comprises access to all lectures, receptions, lunch, dinner and transfer shuttle from and to Graz airport. (Accommodation is not included in the registration fee. The overnight charge, including breakfast, with € 98 per person willbecoveredindividuallydirectlyinthehotel.ThebookingoftheroomatSchlossSeggauwillbefixedwithyouronlineregistration).

The online registration form you may find on our website: www.zeta.com/symposiumWe would be glad to welcome you and your team at the ZETA Symposium in March 2019!

In case of any further questions please don’t hesitate to contact Ms. Andrea Zotter (Executi-ve Assistant at ZETA) under: + 43 3136/ 9010 110 or send an email to [email protected]. Our symposium organization team will be very happy to assist you!

Kind regards,ZETA Team

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The ZETA Symposium is sponsored by:

www.zeta.com/symposium