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Safe Gene Therapies

On-Demand Validation for Gene Therapy Development

To adequately assess the safety and efficacy of candidate gene therapies, robust bioanalytical technologies must support regulated studies. Hence, many labs now incorporate the latest qPCR and digital PCR (dPCR) methods into their preclinical and clinical development workflows to assure data accuracy and product effectiveness.

Despite this, a lack of regulatory guidance on assay development and validation can make it difficult to choose appropriate techniques.

This webinar highlights several essential considerations that can help you choose the right molecular assay for your bioanalytical needs. 

Download this webinar to learn more about:

  • Best practices for the experimental design and performance of qPCR and dPCR
  • The analysis of biodistribution, transgene expression and vector shedding
  • Validation parameters and acceptance criteria to ensure assay suitability
Dr. Amanda L. Hays
Dr. Amanda L. Hays
Ph.D. Scientific Officer, Senior Director at BioAgilytix
Dr. Kelly Colletti, PhD, MBA
Dr. Kelly Colletti, PhD, MBA
Director, Preclinical Bioanalytics at Beam Therapeutics
Dr. Niketa Jani, Ph.D.
Dr. Niketa Jani, Ph.D.
Manager I, BioAgilytix Laboratories

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