Pall Biotech

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Scale up and Risk Mitigation of Therapeutic Viral Vectors for Gene Therapy

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Duration:
60 Minutes
 

Summary

With multiple products on the market, gene therapy has now gone beyond proof of concept and entered mainstream healthcare. This success urgently requires work on manufacturing processes to ensure that gene therapies are widely available to all that need them. Furthermore, regulatory authorities, tasked with assuring quality, efficacy and safety of the final product, are placing increasing scrutiny on the manufacturing process. Regulatory guidance documents suggest that the risk of adventitious agent contamination should be assessed and mitigated through a risk-based approach.

In this webinar, we will outline key considerations in choosing the right technology for scale up in adherent and suspension cell cultures and some of the pitfalls that must be overcome to ensure success at large scale. Furthermore, we will detail a process control strategy to mitigate the risk of adventitious agent contamination.

Participants will learn:
  1. What factors to consider when choosing your cell culture
  2. The advantages and disadvantages with each type of culture
  3. A risk based approach for viral vector manufacturing

Speakers

  • Moderator:

    Dr. Clive Glover

    Pall Biotech
    Director, Cell & Gene Therapy

  • Moderator:

    Dr. Rachel Legmann 

    Pall Biotech
    Director, Technical Consultancy, Gene Therapy & Viral Vectors

  • Moderator:

    David Johnson

    Pall Biotech
    Senior Global Product Manager, Continuous Purification

  • Moderator:

    David Johnson

    Pall Biotech
    Senior Global Product Manager, Continuous Purification

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