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

 

 

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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Integrity Assurance for Single-Use Systems An End-User’s Perspective

 

What should you consider when building an integrity control strategy for your single-use systems (SUS)? How do you overcome application challenges?

 

Join leading industry experts Charlotte Masy of GSK and Patrick Evrard from Pall Corporation to gain insights and answers in this webinar from BioPharma Asia on integrity Assurance for Single-Use Systems, an End-User’s Perspective. They will present several case studies to show how integrity concerns can be practically addressed for cGMP manufacturing applications and the results observed a few years on. 

 

Attendees will learn about:

 

  • The latest regulatory requirements for integrity assurance of SUS
  • The different technologies available to control integrity of SUS
  • Key parameters that affect integrity measurements

 

Register now for this webinar from industry experts on October 6.

 

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