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Keeping the (Adventitious) Virus Out of the (Adeno-Associated) Virus



WEBINAR

How do you define a strategy for viral clearance for a process that inherently aims at purifying a virus?

Gene delivery using AAV has received a boost from two major approvals and the nearly 300 programs in the clinic. Novel gene therapies using viral vectors enable companies to transform the lives of people living with certain rare and ultra-rare diseases where treatments are often not available currently. Among a multitude of challenges in viral vector bioprocessing, uncertainty in regulatory expectations is a major challenge to gene therapy developers. Regulatory requirements are evolving as the science and manufacturing mature with more stringent measures for viral safety assurance expected for future approvals.

Learn how to implement techniques for adventitious virus removal in your viral vector process; we will focus on strategies for viral clearance along your journey towards commercial readiness of AAV-based processes.

In this webinar, you will learn:

  • AAV process flows and focus areas for viral safety
  • Strategies for implementing viral clearance measures in bioprocessing
  • Case studies and data-driven approaches on log reduction values (LRV) in a viral vector process

Speaker

Ratish Krishnan

Ratish Krishnan

Merck

Senior Strategy Consultant

Ratish Krishnan is a senior strategy consultant in novel modalities bioprocessing. He has nearly 15 years of bioprocessing experience in vaccine, monoclonal antibodies, and viral vector modalities from pre-clinical to late-stage process characterization, validation, and commercialization activities. Ratish has led process development teams at Novartis and Pfizer prior to his current role where he serves as a global subject matter expert for viral vector manufacturing and provides strategic guidance to stakeholders and key customers. He is active in thought leadership activities at scientific conferences, technical webinars, and key authorship contributions in peer-reviewed articles.