PDA Europe Training Course

The Parenteral Drug Association presents:

All About
Virus Filtration
- A Practical Approach

18-19 September 2018

Asahi Kasei Bioprocess Europe
Cologne | Germany
WELCOME TO COLOGNE
 TWO-DAY TRAINING COURSE

All About Virus Filtration

A Practical Approach

Overview
This training course about virus filtration will provide the attendees with a profound understanding about the current state of the art
around this topic. A thorough introduction to virus filtration will be given as well as in-depth background and a mechanistic understand-
ing about the principles of (parvo-) virus retention will be available to the attendees at the end of the course. An interactive session will
address the question of “how to design an efficient virus filtration process?” and a practical session will provide some hands-on experi-
ence with lab- and production-scale virus filter modules.

Who Should Attend: Learning Objectives:

• R&D scientists Upon completion of the course the participant
• Supervisors in manufacturing
• have understood virus filtration principles
• QA Manager (Regulatory Affairs, Pathogen Safety)
• ability to set-up and handle virus filtration processes
• have an overview of filter types and material
• have understood challenges of different matrices
• have gained hands-on experience with virus filters / process
set-ups
• have understood principles/requirements of filter integrity
testing
• have an overview of current guidelines and regulations

Sebastian B. Teitz, PhD, Lab- & Product Manager, Asahi Kasei Bioprocess Europe
Sebastian Teitz graduated from University of Cologne with a diploma in Genomic Imprinting, followed with a PhD in the Analysis of
O-glycosylated Proteins. Sebastian has previously worked at Fred Hutchinson Cancer Research Center (Seattle, WA), looking into
Cytomegalovirus and its role in Graft vs. Host Disease and Transplant Rejection and at NewLab BioQuality / Charles River as the Project
Manager of Virus Clearance Studies, focusing on scientific liaison with customers. At Asahi his focus lies with the technical, scientific and
regulatory support of customers and internal entities, as well as representation in various industry organizations, such as the PDA, BPOG
and CAACB.

Andy Bailey, CEO, ViruSure GmbH

Andy Bailey is a virologist who served for 9 years at the MRC Virology Unit in Glasgow. In 1995, he moved to the industry sector, initially
as Director of Virus Validation services with Q-One Biotech Ltd, and later at the Pathogen Safety group of Baxter Healthcare in Vienna,
Austria. Over the last 20 years Andy has been actively involved in the virus and prion safety field, presenting at numerous regulatory agencies
either in support of products at the UK MHRA, German PEI, French AFFSAPS, US FDA, KFDA (Korea), EMEA and JMHLW (Japan) supporting
regulatory submissions for various products. He has extensive experience in regulatory affairs and virus safety issues. Since 2005 he has
been the founder and CEO of ViruSure in Vienna, Austria, a company specialising in the virus and prion safety of biopharmaceutical products

Franz Nothelfer, Consultant

Franz Nothelfer is consultant for downstream processing and viral safety. Before his retirement in 2017, he was heading a position as
associate director Protein Science at Boehringer Ingelheim Pharma (BI), responsible for the development of novel purification processes for
therapeutic proteins and monoclonal antibodies. A major task of his team was the transfer, establishment and optimization of purification
processes of customers to achieve robust and economic manufacturing processes. Franz started his career in 1971 at Dr. Karl Thomae GmbH
(later BI). In 1979 he joined the newly founded biotechnology department and was involved in the first process transfer of a recombinant
protein to BI in 1985. During his career at Boehringer Ingelheim he took over several challenging positions.

Michael Lasse, PhD, Study Director Supervisor, Charles River Biologics Testing Solutions
Michael Lasse graduated from the University of Rostock with a diploma in Biology working on programmed cell death in neural progenitor
cells. At the University of Cologne his PhD studies in Biochemistry focused on recombinant protein expression of apoptosis relevant
membrane proteins, chromatographic purification techniques and post-translational lipid modifications. Michael Lasse joined Charles
River as a study director for viral clearance studies and is currently supervising an operational team within the viral clearance department
focusing on chromatography and related topics like continuous processing.

pda.org/eu/VirusFiltration2018 3
 TWO-DAY TRAINING COURSE

Competition Clause: We ask you for your understanding that participants of competing companies cannot take part in the training course.

Tuesday, 18 September 2018 8:30 – 17:00

8:30 Welcome and Theory 1 Sebastian Teitz
• Introduction into eukaryotic DS manufacturing process Andrew Bailey
• Virus Filters in biopharmaceutical manufacturing
• Sources of virus load
• Reason/necessity for virus removal from DS
• Brief overview of guidelines
• Methods for virus removal

10:00 Coffee Break

10:30 Hands-on 1: Set-up and Handling of Filters Sebastian Teitz

• Set-up in lab-scale: hands-on
• Display of production scale filters
• Integrity tests: hands-on
• Demonstration of integrity test automation

12:30 Lunch Break

13:30 Theory 2: Case Study Franz Nothelfer

• Up- & Downscaling of a virus filtration step

15:00 Coffee Break

15:30 Interactive Session: Sebastian Teitz

Designing a virus filtration process – assumption and points to
consider
• How to design a process
• Calculating production costs

17:00 End of Day 1

18:00 Networking Dinner

4 pda.org/eu/VirusFiltration2018
 TRAINING COURSE AGENDA

Wednesday, 19 September 2018 8:30 – 15:30

8:30 Wrap-up Day 1 Sebastian Teitz

9:00 Theory 4: Sebastian Teitz

• Mechanistic principles of (Parvo-) Virus retention
• Virus filters as bioprocess subject – current hot topics (ATMPS,
facility segregation, etc.)
• Challenges of implementing virus filtration into continuous manu­
facturing

10:30 Coffee Break

11:00 Theory 5: Michael Lasse

• How to organize a virus clearance study
• Challenges in VC studies
• Historical data
• Case studies for VC studies

12:30 Lunch Break

13:30 Interactive session: Sebastian Teitz

Pitfalls in the development of a virus filtration process
• Bring your own case/topic/question/problem/challenge for
discussion!

Participants have the opportunity to address real-life challenges

during the implementation of a virus filtration process –
from bencht-top development through to commercial scale-up.

15:00 Wrap-up, Q&A Sebastian Teitz

15:30 End of Course

pda.org/eu/VirusFiltration2018 5
 INFORMATION

T R A I N I N G LO C AT I O N GENER AL ADDRESS
Asahi Kasei Bioprocess Europe PDA Europe gGmbH
Gottfried-Hagen-Strasse 20 Am Borsigturm 60
51105 Cologne 13507 Berlin, Germany
Germany Tel: +49 30 436 55 08-0
Fax: +49 30 436 55 08-66
CO N TAC T I N FO R M AT I O N
Registration Customer Care
Tel: +49 30 436 55 08-10
[email protected]
Education Program Inquiries
Elke von Laufenberg
[email protected]

HOTELS NEARBY
PDA Europe recommends the reservation at one of the following
hotels. The general terms of business are valid at the hotels.

Leonardo Hotel Köln

Waldecker Str. 11-15
51065 Cologne
Tel.: +49 (0)221 - 670 90
[email protected]
https://goo.gl/PwRnR3
Price per Room and Night upon Request.
Distance to the venue: 2. 1 km (7 min by the car)

PDA Europe supports the Pullman Hotel Cologne

children's hospice „Sonnenhof” Helenenstraße 14
The Sonnenhof Hospice, located near PDA’s office in 50667 Cologne
Berlin, offers support and assistance to families with Tel.: +49 (0)221- 2750
children suffering from incurable and/or debilitating https://goo.gl/xrsX
diseases. At Sonnenhof, children, together with their Price per Room and Night upon Request.
families, can spend the time they have left as they wish Distance to the venue: 6. 3 km (19 min by the car)
and find some relief from their suffering. Instead of
purchasing expensive gift s for the conference speak-
ers, PDA has decided to donate this amount to the
Sonnenhof Hospice. You can also contribute and help
us increase the amount, it is easy:
buy a package of chewing gums at the
registration desk. THANK YOU!

To know more about the Sonnenhof Hospice,

please visit www.bjoern-schulz-stiftung.de

6 pda.org/eu/VirusFiltration2018
 All About Virus Filtration For contact at PDA Europe
18-19 September 2018 | Cologne | Germany [email protected]

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Two-Day Training Course (18-19 September) By Credit Card
All About Virus Filtration
All Participants 1495 American Express MasterCard VISA
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The fee includes course documentation as well as mid-session refreshments
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PDA event. PDA Europe reserves the right to deny access to anyone unable to provide written confirmation that all dues have been fully settled. SUBSTITUTIONS: If you are unable to attend, substitutions are welcome and can be
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pda.org/eu/VirusFiltration2018 7
 2 0 1 8 P D A E U R O P E E V E N T S
15-16 October Pharmaceutical Microbiology Berlin, Germany

23-24 October Visual Inspection Forum Berlin, Germany

6-7 November Outsourcing & Supply Chain - A 360° View Seville, Spain

22 November Project Management in the Pharmaceutical Industry –

Berlin, Germany
Challenges & Possibilities

27-28 November Pharmaceutical Freeze Drying Technology Seville, Spain

27-28 November 11th Workshop on Monoclonal Antibodies Seville, Spain

2 0 1 9 P D A E U R O P E E V E N T S
19-20 March Parenteral Packaging Venice, Italy

Subject to change For latest info: europe.pda.org Shortlist 10 Jul 2018

Events with additional Education Program. More information – europe.pda.org

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13507 Berlin, Germany
Tel: +49 30 4365508-0
Fax: +49 30 4365508-66 europe.
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