Viral Safety of Cell Banks: Replacing Animal-Based Assays by One Single GMP Transcriptomic Test

Just how close to singularity is the use of NGS in biosafety testing to replace animal assays?

Register Free: https://www.biopharminternational.com/bp_w/transcriptomic-test

Event Overview:

After much anticipation, the revision to ICH Q5A (R2) was finally released in November 2023, ending a multi-year wait to see how a new technology like next generation sequencing (NGS) would finally be positioned in biosafety testing. Much to the relief of those already using NGS as a platform technology in this arena, NGS was finally green-lit as an advanced testing tool and ethical replacement for two mandatory animal-based assays: in vivo adventitious virus and mouse/hamster/rat antibody production (MAP/HAP/RAP) tests.

Despite this positioning, many questions in the industry seem to remain. For example, what is the actual sensitivity of any given NGS test method? Are these assays robust enough to detect a full range of viruses? Does detection correlate with infection? And more importantly, can NGS be used to replace more than these animal-based tests in a single test?

Quite simply, just how close is NGS to becoming the singular platform to replace the current spectrum of animal through molecular-based biosafety tests? Understanding where we stand today with current advancements and comparability tests using NGS to address these questions is critical.

Key Learning Objectives:

• Regulatory framework in viral safety surrounding NGS adoption
• Holistic understanding of role of NGS in biosafety testing
• Current data supporting NGS sensitivity and robustness versus in vivo tests
• Benefits of NGS GMP transcriptomic assay over animal-based conventional methods

Who Should Attend:

• CMC Managers
• Consultants
• Chief Technical Officers
• QC Managers
• R&D Managers
• Bioprocess Development Managers
• Scientists
• Scientific Directors
• Upstream or Downstream Development Managers
• CEOs
• Directors of Cell Culture Development

Speaker:

Colette Côté, PhD
US General Manager, Chief Scientific and Portfolio Officer
PathoQuest

Dr Côté joined PathoQuest's US subsidiary as General Manager and Chief Scientific and Portfolio Officer in March 2021. Prior to this, she was Head of NGS R&D Testing Services at MilliporeSigma. Dr Côté received a PhD in Molecular Biology, Cell Biology, and Biochemistry from Brown University and was a post-doctoral fellow in the Genetics and Biochemistry branch of the National Institutes of Health (NIH).

Register Free: https://www.biopharminternational.com/bp_w/transcriptomic-test