Next-generation sequencing in adventitious agent testing: navigating regulatory acceptance

Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.

Agnostic next-generation sequencing (NGS) approaches demonstrated efficacy in detecting viral contaminants in cells, with regulatory bodies now encouraging its use as a replacement for in vivo assays. The recent revision of the ICH Q5A guideline demonstrates regulators' readiness to embrace modern techniques like NGS.
A strategic approach for developers would be to replace all in vivo assays and specific virus tests/panels while retaining functional assays such as in vitro adventitious agent testing, cell-based retroviral testing (e.g., S+L−), and electron microscopy. Agnostic NGS is an optimal virus screening and virus characterization strategy, particularly when speed, sample volume, and the challenge of antibody neutralization are pressing concerns.

In this webinar, Charles River biologics experts, Olaf Stamm, PhD, and Horst Ruppach, PhD, answer frequently asked questions about the use of NGS as an adventitious virus assay, from its utility in the lab to regulatory requirements.

• Advantages of NGS testing as a potential alternative to in vivo adventitious agent testing methods
• Strategies to implement NGS-based testing methods in line with the latest regulatory guidance
• Specific pros and cons of using NGS testing for adventitious virus testing

Olaf Stamm

Technical Business Development Director at Charles River Laboratories, Inc

Dr. Stamm holds a doctoral degree in molecular parasitology and a master’s degree in drug regulatory affairs from the University of Bonn, Germany.

He joined Charles River in 2003 and became responsible for the business development activities in Europe and Asia. Prior to joining Charles River, he worked for Eurofins Scientific running their microbiological GMP testing laboratories in Switzerland. While being for many years the global subject matter specialist for impurity testing, most recently Dr. Stamm has focused his work on analytical/regulatory consulting for Charles River Biologics Services in Asia and Europe.

Horst Ruppach

Executive Director, Scientific and Portfolio, Global Biologics at Charles River Laboratories, Inc

Dr. Horst Ruppach studied chemistry at the University of Cologne and the University of Marburg, Germany and earned his PhD in Virology (HIV) at the Georg Speyer House, Frankfurt. He has 30 years of experience in the field of virology. His scientific, technical, and regulatory expertise is in virus safety testing and virus/prion clearances studies for Biologics including Cell- and Gene Therapy products. By expanding his expertise to all analytical characterization and testing required for Biologics from entering the clinical phase to commercialization he adopted the scientific leadership role at Charles River Biologics 2019. He supports and coordinates global analytical service developments and actively manages Charles River Biologic’s Testing portfolio.

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SPEAKERS

Olaf Stamm

Technical Business Development Director at Charles River Laboratories, Inc

Horst Ruppach

Executive Director, Scientific and Portfolio, Global Biologics at Charles River Laboratories, Inc

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