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Applying Next Generation Sequencing for Adventitious Virus Detection



WEBINAR

Next Generation Sequencing (NGS) technology has taken center stage on the world platform as a suitable alternative methodology to traditional broad virus safety screening in biologically derived products as both the industry and regulators progress initiatives to replace, reduce, and refine (3Rs) animal testing. Global industry and interest groups have been working for over a decade to demonstrate the suitability of the technology to serve as a primary virus screening method.

As a result, NGS-based methods have been used for virus detection for many years to ensure the safety of both clinical and commercial products. Recent updates to the ICH Q5A virus safety guidance encourage the use of NGS as a replacement for in vivo and in vitro adventitious testing methods.

The revised guidelines provide the expectations of a well-validated method that can be used for the detection of known and unknown viruses. In this presentation, we will discuss the drivers behind the use of the technology, our approach to the validation of an NGS-based adventitious agent method, and the robust bioinformatic analysis that makes it all possible.

In this webinar, you will learn:

  • The regulatory drivers and worldwide initiatives behind the movement to NGS-based virus testing methods
  • How the methodology and bioinformatics is validated for its intended purpose and applied in the highly regulated GMP environment
  • Hear about real-life case studies showcasing the use of the technology to ensure virus safety in biological products

Speakers

Bradley Hasson

Bradley Hasson

Merck

Director of Lab Operations for NGS Services

Bradley Hasson is the director of lab operations for next-generation sequencing services. Brad leads a team of scientists, laboratory technicians, and bioinformaticians that perform NGS-based biosafety testing services in support of product characterization and release worldwide.

Brad has 15 years of experience developing and implementing molecular-based methods for the purposes of lot release and characterization testing in a variety of biologically derived products.

Leyla Diaz

Leyla Diaz

Merck

Principal Scientist

Leyla is a principal scientist in field development services. She provides scientific and regulatory input in biosafety testing and characterization of biological therapeutic products. She has 17 years of industry experience in product development of therapeutic antibodies and assay development for large molecules and vaccines.

Edmund Ang, Ph.D.

Edmund Ang, Ph.D.

Merck

Senior Technical Expert, APAC

Edmund Ang, a senior technical expert, joined Merck's BioReliance biosafety testing in 2017. He provides technical support on CMC testing of biotherapeutics to biopharma developers and manufacturers in Asia Pacific. He holds a Ph.D. in cell biology from the University of Edinburgh and conducted his postdoctoral research on cell signaling at Stanford University and National Cancer Centre, Singapore.

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