The Regulatory Framework of Virus Filtration

The Regulatory Framework of Virus Filtration

Many biopharmaceutical therapies, such as mAbs and blood plasma factors, are produced using biological materials. This carries the risk that microorganisms such as viral contaminants may be unintentionally introduced into the manufacturing process and contaminate the product.  Thus of paramount importance is the removal of such adventitious agents using effective viral filtration methods.

 

In this webinar, the fundamental principles of virus filtration as well as its practical execution will be discussed.  In addition, participants will gain an in-depth understanding of filterability, validation and the local regulatory framework surrounding virus filtration processes.  By the conclusion of the session, all attendees should be able to conduct a virus filterability trial and will be well equipped to have appropriate discussions with validation labs.

 

Participants will learn:

  • Regulatory framework
  • Principles of virus filtration
  • How to maximize virus safety at minimized cost
  • How to validate continuous viral clearance process

Speaker

 

 

Charlotte Masy

Morven McAlister Ph.D.

Global Sr. Director, Regulatory and Validation Consultancy

Pall Biotech

Dr Morven McAlister is the Global Senior Director of the Regulatory and Validation Consultancy team at Pall Biotech. She is currently involved in using Quality by Design (QbD) principles for new process applications, product, and method development, as well as supporting microbial risk mitigation practices for end-users. She is also actively involved in various industry task forces (e.g. BPOG, PDA, ASTM) to standardize methods and technical positioning around microbial contamination control.

Biography

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May 2021
Overcome Exosome Production Challenges

Biotech | Pall Corporation 웨비나 시리즈

This webinar was recorded by BioPharma Asia and first published on their website. https://biopharma-asia.com. It is made available here by kind permission of BioPharma Asia and the presenters. Scroll down to see a transcript of the webinar question and answer session.

 

Hailed as the “next frontier” in cell therapy and regenerative medicine, exosomes are a type of extracellular vesicle and play a key role in the regulation of the intercellular communication processes.

David Haylock of VivaZome will present on upstream production of angiogenic exosomes using the iCELLis® nano fixed bed bioreactor. This will be followed by a presentation by Roberto Ciboldi of Pall Corporation on a platform solution including cell culture, purification and sterile filtration of exosomes.

Participants will be able to:

 

  • Compare the performance of the iCELLis Nano bioreactor to traditional flasks for exosome production from adherent cell culture
  • Understand how an integrated end to end platform delivers highly   purified and consistently-sized exosomes
  • Discover an innovative cGMP scalable manufacturing platform for   exosomes
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