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.

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December 2020
Servicios de Validación de Filtración y Single Use Technology

Biotech | Pall Corporation webinar series

¡Todo sobre los ensayos de validaciones para cumplir con los máximos estándares regulatorios!

Hablaremos sobre puntos cruciales de los servicios de validación, incluyendo:

1. Necesidad de validación

2. Cómo se realizan los ensayos de validación

3. Análisis de riesgo: re uso de filtros y toma de decisión en ensayos a realizar

4. Servicio de Validación Pall: documentación requerida para iniciar una cotización

¡No pierdas esta segunda oportunidad!

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