From PCR to biomarkers: a case study evaluation of bioanalytical challenges in cell and gene therapy products
While new and existing technologies and tools have come to support the bioanalysis needs of cell and gene therapy products, several challenges remain unaddressed.
Molecular testing platforms, such as qPCR, ddPCR and NGS are critical for cell and gene therapy products enabling the quantification of key endpoints such as gDNA, mRNA, %editing etc. Although these approaches have been around for decades, if not longer, their application in bioanalytical assays for this category of therapies is a more recent development.
Additionally, the development of cell and gene therapy products has also increased the importance and scrutiny of biomarker assays to support the pharmacodynamics of the drug candidate.
However, specific guidance for validation from regulatory authorizes and sharing of troubleshooting approaches are limited. During this webinar, we will discuss bioanalytical platforms typically used during the development of cell and gene therapy products and provide a variety of case studies highlighting troubleshooting and risk assessment/acceptance criteria examples.
What will you learn?
- What platforms are being used for cell and gene therapy programs and why
- How are acceptance criteria applied when specifications from health authorities are not available
- For biomarkers – when are CLIA assays appropriate and when would FDA regulated fit-for-purpose assays provide a better approach
Who may this interest?
- Bioanalysts
- Pharmacologists
- Toxicologists
- Immunologists
- Individuals in cell and gene therapy space
Speaker
Stephanie Pasas-Farmer,
President and Founder, Ariadne Software, LLC (KS, USA);
Principal Consultant and Founder, BioData Solutions, LLC (AZ, USA)
Stephanie Pasas-Farmer is the Founder and President of Ariadne Software. She is a recognized bioanalytical expert with experience in the areas of discovery and regulated bioanalysis for pharmaceutical, biologics and hybrid technologies, including antibody−drug conjugate technology. Most recently, she launched BioData Solutions, to help sponsor advance early-stage molecules into potential new drug candidates with bioanalysis support and regulatory compliance planning.
Stephanie earned her PhD and MSc degrees with honors in pharmaceutical chemistry from the University of Kansas (KS, USA). She received a BS degree in chemistry from St. Mary’s College of Notre Dame (IN, USA).
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