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Viral Safety of Cell Banks: Replacing Animal-Based Assays by One Single GMP Transcriptomic Test
This event will be available for on-demand viewing soon.
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
Featured Speaker
Colette Côté, PhD
US General Manager, Chief Scientific and Portfolio Officer
PathoQuest
Dr. Colette 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).
Email:
colette.cote@pathoquest.com
For any technical questions, please contact
Jordan Ramesh:
jramesh@mjhlifesciences.com
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