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Parenteral Drug Association Connecting People, Science and Regulation ®

All About Virus Filtration - A Practical Approach

Sep 18 - Sep 19, 2018 |
Sep 19, 2018 |
Asahi Kasei Medical | Cologne, Germany
  • Education
  • Europe
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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 understanding 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 experiencewith lab- and production-scale virus filter modules.

Who Should Attend

  • R&D scientists
  • Supervisors in manufacturing
  • QA Manager (Regulatory Affairs, Pathogen Safety)

Learning Objectives

Upon completion of the course the participant

  • have understood virus filtration principles
  • 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

Instructors

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.

Tuesday, 18 September 2018

8:30
Welcome and Theory 1

  • Introduction into eukaryotic DS manufacturing process
  • 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

  • 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

  • Up- & Downscaling of a virus filtration step

15:00
Coffee Break

11:00
Interactive Session:
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

Wednesday, 19 September 2018

8:30
Wrap-up Day 1


9:00
Theory 4:

  • 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 manufacturing

10:30
Coffee Break


11:00
Theory 5:

  • 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:
Pitfalls in the development of a virus filtration process

  • Bring your own case/topic/question/problem/challenge for discussion!

15:00
Wrap-up, Q&A


15:30
End of Course

3 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • 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 submitting 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).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

All Participants

1495 Euro

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

Training Location

Asahi Kasei Medical
Gottfried-Hagen-Strasse 20
51105 Cologne
Germany


Hotels Nearby

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

Leonardo Hotel Köln
Waldecker Str. 11-15
51065 Cologne
Tel.: +49 (0)221 - 670 90
Email
Hotel Website
Price per Room and Night upon Request
Distance to the venue: 2. 1 km (7 min by the car)


Pullman Hotel Cologne
Helenenstraße 14
50667 Cologne
Tel.: +49 (0)221- 2750
Hotel Website
Price per Room and Night upon Request
Distance to the venue: 6. 3 km (19 min by the car)

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4184

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