Validation and Transfer of Biodistribution and Viral Shedding Assays In Development of An Oncolytic Virus Immunotherapy Candidate

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Discover how validated molecular and infectivity assays supported the clinical development of an oncolytic virus immunotherapy.

Evaluating the safety of oncolytic virus therapies requires a thorough understanding of viral biodistribution, shedding, and infectivity. This case study highlights the development and validation of qPCR and tissue culture infective dose (TCID<sub>50</sub>) assays used to characterize viral behavior and support the clinical evaluation of an investigational oncolytic virus therapy.

Key highlights include:

  • Validation of virus-specific qPCR assays for multiple specimen types
  • Implementation of TCID50 testing to assess viral infectivity in qPCR-positive samples
  • Correlation studies evaluating viral DNA copy number and infectious virus measurements
  • Investigation of biodistribution, viral shedding, and potential transmission during treatment
  • Generation of data supporting the safety profile and clinical development of an oncolytic virus immunotherapy candidate

This case study demonstrates how integrated bioanalytical expertise can help sponsors characterize complex viral therapies, generate confidence in clinical data, and advance innovative immunotherapy programs.

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Validation and Transfer of Biodistribution and Viral Shedding Assays In Development of An Oncolytic Virus Immunotherapy Candidate

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