Utilizing ddPCR for siRNA Bioanalysis
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Background: siRNA is a promising therapeutic modality highlighted by several US FDA approvals since 2018, with many more oligonucleotide assets in clinical development. To support siRNA discovery and development, robust and sensitive quantitative platforms for bioanalysis must be established to assess pharmacokinetic/pharmacodynamic relationships and toxicology. Droplet digital PCR offers improved sensitivity and throughput, as well as reduced susceptibility to matrix effects, compared with other analytical platforms. Methodology: The authors developed a stem-loop reverse transcription droplet digital PCR method to measure siRNA in mouse plasma and liver extract using bioanalytical method qualification guidelines. Conclusion: This newly developed assay has been demonstrated to be a superior alternative to other platforms, with the added benefit of greater sensitivity, with dynamic range from 390 to 400,000 copies/reaction and readiness for FDA investigational new drug-enabling applications.
Megan Turski
Megan Turski received her B.A. in Biology from University of Wisconsin-Madison. She has over 10 years of experience in bioanalysis working in the pharmaceutical industry. She began her career working in an FDA-regulated bioanalytical laboratory using LC-MS/MS and continued on to quantitative method validation and development for ligand binding assays and qPCR. She is currently a Scientist in the Drug Metabolism and Pharmacokinetics group at Takeda Pharmaceuticals in San Diego, CA. She primarily supports the bioanalysis for oligonucleotide drug candidates as well as the delivery platform development. Her current research focuses on developing PCR methods for oligonucleotides to determine pharmacokinetics and biodistribution of these drug candidates.
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