PALSAR Bioanalysis of Oligonucleotides to Support Drug Development

Contract Services Bioanalysis Intermediate Molecule Bioanalysis PALSAR Analytical Method

The Medical Analytical Services department offers non-regulated bioanalysis of oligonucleotides and other intermediate molecules to determine accurate measurement of parent drug and/or metabolite concentration in various biological matrices to support ADME (absorption, distribution, metabolism, and excretion), DMPK (drug metabolism and pharmacokinetics), and DDI (drug-drug interaction) studies in drug development.

Our PALSAR Method for Bioanalysis of Oligonucleotides

PALSAR which stands for Probe Alternation Link Self-Assembly Reaction is a proprietary Hybridization method for the measurement of oligonucleotide drugs. The PALSAR technology was developed and is employed by the Drug Development Solutions Center of SEKISUI.

PALSAR is a novel high sensitive and specific quantitative method for detecting nucleic acids that amplifies signal, not sequence. PALSAR works by using a DNA self-assembly composed of thousands of probe pairs as a signal amplifier when linked to a typical hybridization assay.

Principle of PALSAR Method for Bioanalysis

Signal Amplification Method

PALSAR Bioanalytical Capabilities

• ADME in mice, rabbits, monkeys, rats and dogs
• Quantitative analysis in various matrices including:
  • Serum
  • Plasma
  • Tissue

PALSAR Bioanalysis Instrumentation

• High Throughput Analysis using standard micro-beads or 96-well plates
• Conventional instrumentation, such as:
  • Luminex (Luminex® 100/200TM System)
  • Meso Scale Discovery Electrochemiluminescence (MSD ECL/MSD® QuickPlex SQ120TM System)

Additional Resources

• Establishment of PALSAR method for quantification of human cells in mouse kidney (2022 JSSX Poster)
• Highly selective and sensitive hybridization-based assay for quantification of ASOs drug using signal amplification method (2022 APA Poster)
• A Novel ADA Screening Assay for Immunogenicity Testing of Oligonucleotide Drug Using PALSAR Technology (2022 APA Poster)
• Investigation of the PPB method for oligonucleotide drugs by using the PALSAR (2022 NATS Poster)
• Establishment of the PPB method for antisense oligonucleotides (ASOs) by using the PALSAR method (2021 JSSX Poster Presentation)
• Ultrasensitive quantitation assay of oligonucleotide therapeutics based on the PALSAR method (2018 JSSX Poster)