Digital PCR has become the emerging technique for the sequence-specific detection and quantification of nucleic acids for various applications. During the recent years, numerous articles of new digital PCR methods have been published. Considering the development work into reliable analytical methods suitable for diagnostics requires their validation for the intended use. The results of an in-house evaluation of a droplet digital PCR compared to other technologies will be presented in application to different genomic assays applied in gene therapy.

Learning Objectives:

1) Introduction to Droplet Digital PCR

2) Explain the need for Droplet Digital PCR compared to current methodologies in different gene therapy platforms

3) Present the key evaluations required to establish the assay for research and good manufacturing purpose.