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9 th <strong>European</strong> <strong>Downstream</strong> <strong>Technology</strong> <strong>Forum</strong> &<br />

3 rd <strong>Upstream</strong> <strong>Technology</strong> <strong>Forum</strong> – Linked Event<br />

September 9 – 10 | 10 – 11, 2013<br />

Sartorius College, Goettingen, Germany<br />

turning science into solutions


Invitation<br />

Agenda<br />

Chairs<br />

Dr. Christel Fenge, Davy De Wilde Fermentation Technologies,<br />

Sartorius Stedim Biotech, Germany<br />

<strong>Upstream</strong> and <strong>Downstream</strong><br />

Processing: One Common Goal<br />

Successful process optimization<br />

in upstream has led to increased<br />

cell densities and product titers.<br />

But what does this mean for downstream<br />

processing and purification<br />

of the final drug product?<br />

These modern, intensified<br />

production processes are pushing<br />

the bottleneck more and more<br />

towards downstream.<br />

The need to address this has become<br />

stronger than ever before.<br />

This year, in an attempt to bring<br />

upstream and downstream specialists<br />

closer together, our established<br />

<strong>Upstream</strong> <strong>Technology</strong> <strong>Forum</strong> and<br />

<strong>European</strong> <strong>Downstream</strong> <strong>Technology</strong><br />

<strong>Forum</strong> will be held back-to-back. It<br />

will offer you the opportunity to<br />

gain knowledge and share experience<br />

with experts from the industry.<br />

The joined session will further provide<br />

an opportunity for interdisciplinary<br />

discussions to address the<br />

bottlenecks at the interfaces of<br />

upstream and downstream.<br />

Topics will include challenges of<br />

high titer processes and potential<br />

resolutions, Quality by Design and<br />

continuous bioprocessing.<br />

Take a look at the respective agenda<br />

and select which of the forums you<br />

would like to attend.<br />

You will find up-to-date information<br />

posted on our website:<br />

www.sartorius.com/<br />

upstream-downstream-forum.<br />

Seize the opportunity of this unique<br />

set-up and book both events as a<br />

package. Broaden your process<br />

understanding and update your<br />

knowledge in upstream and downstream<br />

processing while meeting<br />

experts from the industry.<br />

Monday, September 09<br />

10:00 – 11:00<br />

Plant Tour<br />

11:00 – 11:30<br />

Registration<br />

<strong>Upstream</strong> <strong>Forum</strong><br />

Lunch | Exhibition<br />

12:30 – 12:45<br />

Welcome & Introduction<br />

Dr. Oscar-Werner Reif,<br />

Executive Vice President,<br />

Member of the Board,<br />

Sartorius Stedim Biotech,<br />

Germany<br />

r Session 1:<br />

Vaccines & Cell Culture Media<br />

12:45 – 13:30<br />

Keynote Presentation<br />

Disposable bioreactors: How to<br />

integrate them into your Process<br />

Development Platform?<br />

Jean-Francois Chaubard,<br />

Director, Cell & Viral<br />

Technologies, GSK Vaccines,<br />

Belgium<br />

13:30 – 14:00<br />

Lecture<br />

Making the Choice between<br />

Suspension & Microcarriers<br />

for Animal Vaccine Processes:<br />

a Comparison Study between<br />

Single-use and Multi-use<br />

Bioreactors<br />

Dr. Lidia Garcia Coronado,<br />

Senior Scientist, Veterinary<br />

Medicine Research and<br />

Development, Zoetis Manufacturing<br />

& Research, Spain, S.L.<br />

14:00 – 14:30<br />

Lecture<br />

Media optimization for enhanced<br />

process performance<br />

t.b.d.<br />

Coffee Break | Exhibition<br />

r Session 2:<br />

Process Scale-up &<br />

Manufacturing<br />

15:00 – 15:30<br />

Lecture<br />

Scale up from 2L – 15000L:<br />

Challenges and Lessons Learned<br />

Dr. Michelangelo Canzoneri,<br />

Head of Laboratory <strong>Upstream</strong><br />

Development, Sanofi-Aventis<br />

Deutschland, Germany<br />

15:30 – 16:00<br />

Lecture<br />

Implementation of Single-use<br />

Bioreactors for Scale-up &<br />

Biologics Production<br />

Dr. Anne Gilbert, USP<br />

Director, Product & Process<br />

Development, Novasep Process,<br />

Belgium<br />

Short Break<br />

16:15 – 16:45<br />

Lecture<br />

Strategies towards Superior<br />

Single-use Bioreactors<br />

Dr. Gerhard Greller, R&D<br />

Director <strong>Upstream</strong> <strong>Technology</strong>,<br />

Sartorius Stedim Biotech,<br />

Germany<br />

16:45 – 17:15<br />

Lecture<br />

t.b.d.<br />

Christopher Cruz, Senior Associate<br />

Development Scientist,<br />

Bayer Healthcare, USA<br />

17:15 – 17:35<br />

Q & A | Panel discussion<br />

Closing of day 1<br />

18:30<br />

Transfer to Networking Dinner


Agenda<br />

Chairs<br />

Dr. Uwe Gottschalk, Dr. Susanne Roederstein<br />

Purification Technologies, Sartorius Stedim Biotech, Germany<br />

Tuesday, September 10<br />

r Session 3:<br />

Process Analytical <strong>Technology</strong><br />

(PAT)<br />

08:30 – 9:00<br />

Lecture<br />

Set Up of Glucose Control Loops<br />

for Cell Culture based on the<br />

Online Glc | Lac Measurement<br />

Dr. Wolfgang Paul, Senior<br />

Scientist, Roche, Germany<br />

09:00 – 09:30<br />

Lecture<br />

Realtime Multiparameter<br />

Monitoring during Bacillus<br />

Spore Production by NIR-Online<br />

Spectroscopy<br />

Dr. Dirk Bergmaier, Senior<br />

Scientist, Christian Hansen,<br />

Germany<br />

09:30 – 10:00<br />

Lecture<br />

Mitigating the Biosafety and<br />

Financial Risk of Human Error<br />

when Using Single Use<br />

Dr. Martin Dahlberg,<br />

R&D Manager Instrumentation<br />

& Control, Sartorius Stedim<br />

Biotech, Germany<br />

Coffee break | Exhibition<br />

r Joint Session<br />

<strong>Upstream</strong> & <strong>Downstream</strong><br />

10:30 – 10:45<br />

Welcome & Introduction<br />

Joint Session<br />

Reinhard Vogt,<br />

Executive Member of the Board,<br />

Sartorius Stedim Biotech<br />

10:45 – 11:30<br />

Keynote Presentation<br />

One Common Goal<br />

Dr. Peter Krämer, IA C&B-<br />

Engineering Development,<br />

Sanofi Frankfurt, Germany<br />

11:30 – 12:00<br />

Lecture<br />

Facility of the Future: How Disposables<br />

Support that Concept<br />

Dr. Berthold Bödeker, Global<br />

Biologics Biotech Development,<br />

Bayer Pharma AG, Germany<br />

12:00 – 12:30<br />

Lecture<br />

Virus Filtration of Cell Culture<br />

Media - Dos and Don’ts<br />

Dr. Volkmar Thom, Director,<br />

Precipitation Technologies,<br />

Sartorius Stedim Biotech,<br />

Germany<br />

Lunch Break | Exhibition<br />

13:30 – 14:00<br />

Lecture<br />

Do we still need Centrifugation<br />

for Cell Removal?<br />

Laure Landric-Burtin, Head of<br />

Bioprocesses, DSP Group,<br />

Sanofi Vitry, France<br />

14:00 – 14:30<br />

Lecture<br />

Strategies During the<br />

Development of Tangential Flow<br />

Filtration as Primary Recovery<br />

Step During Microbial Based<br />

Production Processes<br />

Dr. Guido Seidel, Head of<br />

Operations, Wacker, Germany<br />

14:30 – 15:00<br />

Lecture<br />

Applied Chemometrics Enabling<br />

Efficient Bioprocess Development<br />

& Robust Manufacturing<br />

t.b.d.<br />

15:00 – 15:15<br />

Closing Remarks<br />

<strong>Upstream</strong> <strong>Forum</strong><br />

Coffee Break | Exhibition|<br />

Plant Tour<br />

r Start <strong>Downstream</strong><br />

r Session 1:<br />

Innovation in <strong>Downstream</strong><br />

Processing<br />

16:00 – 16:30<br />

Lecture<br />

Innovations in Biopharmaceutical<br />

Production– A Manufacturer’s<br />

Perspective<br />

Abhinav Shukla, Ph.D., Vice<br />

President, Process Development<br />

and Manufacturing,<br />

KBI Biopharma, USA<br />

16:35 – 17:05<br />

Lecture<br />

Effect of Membrane Properties<br />

and Operating Mode on Small<br />

Virus Filtration Performance<br />

Alex Seay, Senior Scientist,<br />

Late Stage Development,<br />

Genentech, USA<br />

Q & A<br />

Closing of day 1<br />

18:30<br />

Transfer to Networking Dinner


Agenda<br />

Chairs<br />

Dr. Uwe Gottschalk, Dr. Susanne Roederstein<br />

Purification Technologies, Sartorius Stedim Biotech, Germany<br />

Wednesday, September 11<br />

r Session 2:<br />

Single-use in <strong>Downstream</strong><br />

Processing<br />

9:00 – 9:45<br />

Keynote Presentation<br />

A CMOs View on Platform<br />

Technologies<br />

Dr. Martin Smith, Head of<br />

Mammalian Development<br />

Services, Lonza Biologics, UK<br />

9:45 – 10:15<br />

Lecture<br />

Full Disposable Solutions in<br />

GMP <strong>Downstream</strong> Processing<br />

Gunther Jaenicke,<br />

Clinical Supply DSP,<br />

Boehringer Ingelheim, Germany<br />

Short Break<br />

10:30 – 11:00<br />

Lecture<br />

A CMOs Example of a Single-use<br />

GMP <strong>Downstream</strong> Process<br />

Adriana Kiędzierska-Mencfeld,<br />

GMP-Production Specialist,<br />

Mabion, Poland<br />

11:00 – 11:45<br />

<strong>Technology</strong> Updates<br />

Amélie Raveneau, Project<br />

Manager, Virus & Contaminant<br />

Clearance, Europe<br />

Claire Roulin, Process Development,<br />

Central & South Europe<br />

Sartorius Stedim Biotech<br />

Coffee Break | Exhibition<br />

r Session 3:<br />

Polishing<br />

12:15 – 12:45<br />

Lecture<br />

Inactivation of Viruses by UVC<br />

Treatment<br />

Katherine F. Bergmann,<br />

Manager, Viral Safety and<br />

Clearance Services, Eurofins<br />

Lancaster Laboratories, USA<br />

12:45 – 13:15<br />

Lecture<br />

t.b.d.<br />

t.b.d.<br />

13:15 – 13:30<br />

Closing Remarks<br />

<strong>Downstream</strong> <strong>Forum</strong><br />

Lunch Break | Plant Tour<br />

14:00<br />

End of <strong>Forum</strong><br />

We look forward to welcoming you<br />

in Goettingen, Germany.<br />

Conference address<br />

Sartorius College<br />

Otto Brenner Str. 20<br />

37079 Goettingen, Germany<br />

Phone +49.551.308.2101<br />

Networking dinner – Monday<br />

t.b.d.<br />

Networking dinner – Tuesday<br />

Restaurant “Graf Isang”<br />

Seestrasse 37<br />

37136 Seeburg, Germany<br />

Phone +49.5507.919880<br />

We encourage you to forward this<br />

invitation to interested colleagues.<br />

Sartorius College, Goettingen


Venue<br />

Sartorius College<br />

Otto-Brenner-Strasse 20<br />

37079 Goettingen, Germany<br />

www.sartorius.com<br />

Phone +49.551.308.2101<br />

Transportation<br />

The nearest airport is Hannover,<br />

about 11 hours by train or car<br />

to Goettingen. The train station is<br />

10 min from the College by taxi.<br />

Directions<br />

On motorway A7 (Hannover-<br />

Kassel) take the exit for<br />

Goettingen Nord (72). Take<br />

first exit for Industriegebiet,<br />

take first exit in roundabout.<br />

Then at the next light, take a left.<br />

The College will appear on<br />

the left-hand side.<br />

Your contacts<br />

For Germany, Austria, Switzerland<br />

and the Netherlands:<br />

Beate Sommerfeld<br />

Sartorius Stedim Biotech,<br />

Goettingen<br />

Phone +49.551.308.3318<br />

Fax +49.551.308.3492<br />

beate.sommerfeld@sartorius-stedim.com<br />

For all other countries:<br />

<strong>Downstream</strong> <strong>Forum</strong>:<br />

Elke Giebeler<br />

Sartorius Stedim Biotech,<br />

Goettingen<br />

Phone +49.551.308.2032<br />

Fax +49.551.308.3705<br />

elke.giebeler@sartorius-stedim.com<br />

<strong>Upstream</strong> <strong>Forum</strong>:<br />

Nadine Engel<br />

Sartorius Stedim Biotech,<br />

Goettingen<br />

Phone +49.551.308.4129<br />

Fax +49.551.308.2377<br />

nadine.engel@sartorius-stedim.com<br />

Registration<br />

The conference fee for joining<br />

<strong>Downstream</strong> or <strong>Upstream</strong> <strong>Forum</strong><br />

(including joint session) is:<br />

¤ 395 + 19 % VAT<br />

¤ 100 + 19 % VAT for academia<br />

This includes the networking dinner,<br />

all breaks and lunches.<br />

The fee for participation in the<br />

combined <strong>Forum</strong> (<strong>Upstream</strong> and<br />

<strong>Downstream</strong>) is:<br />

¤ 495 + 19 % VAT<br />

¤ 150 + 19 % VAT for academia<br />

This includes the networking<br />

dinner, all breaks and lunches.<br />

To register, please either<br />

– register on the Web:<br />

www.sartorius.com/upstream-downstream-forum<br />

– call or e-mail listed contacts


Accommodation<br />

We have arranged discounted<br />

rates for accommodation in the<br />

following hotels in Goettingen:<br />

***Hotel Rennschuh<br />

Rate standard category 45.00 ¤ p.P.<br />

Rate comfort category 51.00 ¤ p.P.<br />

www.rennschuh.de<br />

Phone: +49.551.9009.0<br />

****Best Western Parkhotel Ropeter<br />

Rate standard category 73.00 ¤ p.P.<br />

Rate business category 79.00 ¤ p.P.<br />

www.parkhotel-ropeter.<br />

bestwestern.de<br />

Phone +49.551.902.0<br />

****Best Western Vital Park,<br />

Heiligenstadt<br />

Rate 90.00 ¤ p.P.<br />

www.hotel-am-vitalpark.bestwestern.de<br />

Phone: +49.3606.66370<br />

****Hotel zum Löwen,<br />

Duderstadt<br />

Rate 95.00 ¤ p.P.<br />

www.die2hotels.de<br />

Phone +49.5527.849000<br />

Parkhotel Ropeter<br />

Further hotel infomation:<br />

www.sartorius.com/<br />

upstream-downstream-forum<br />

Shuttle Service<br />

We arrange a shuttle service<br />

from the Sartorius College to the<br />

hotels above and vice versa.<br />

You will find detailed information<br />

in your conference information<br />

and at the hotel receptions.<br />

We advise you that photographs<br />

will be taken at the event which<br />

may be published later. In case you<br />

do not consent to such publication,<br />

we ask you to inform us.

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