New PALSAR Method Now Available for Bioanalysis of Oligonucleotides and Other Intermediate Molecules
KANSAS CITY, Kansas, September 1, 2022 – XenoTech in partnership with the SEKISUI Drug Development Solutions Center (SEKISUI) is proud to announce the availability of their newest analytical method, PALSAR. PALSAR, which stands for Probe Alternation Link Self-Assembly Reaction, is a proprietary hybridization method for the measurement of oligonucleotides, antibody drug conjugates (ADC) and other intermediate molecules. The PALSAR technology was developed and is employed by SEKISUI in Tokai, Japan.
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. The method provides higher sensitivity and solves the selectivity problem that can cause other methods to be insufficient when analyzing intermediate molecules.
The FDA has indicated that oligonucleotide drug developers should reference the January 2020 guidance, “In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions,” as a general framework for conducting in vitro experiments and interpreting data for therapeutic oligonucleotides. In support of this research, SEKISUI provides multiple methods for quantitative analysis, including LC-MS/MS, HPLC, qPCR and Hybridization by ELOSA or PALSAR, depending on the needs of the molecule, for quantification 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.
About XenoTech and the SEKISUI Drug Development Solutions Center
Founded in 1965, the Drug Development Solutions Center is a fully accredited AAALAC International facility offering unparalleled expertise for in vivo ADME contracted research studies. For over 50 years, the Center has grown to offer a broad range of pharmaceutical development research capabilities, from optimization of lead compounds to post-marketing surveillance of drugs. Through our shared past history with the SEKISUI Medical Group, XenoTech and the Drug Development Solutions Center work together to provide drug developers with in vitro and in vivo studies to support nonclinical ADME and DMPK evaluation of novel therapeutics.
XenoTech, LLC is a global Contract Research Organization that provides complimentary unparalleled in vitro ADME / DMPK / Drug-Drug Interactions experience utilized by 98% of top pharma companies and numerous other organizations. For more than 25 years, the company has offered proven drug development expertise in evaluating drug candidates in compliance with regulatory requirements and guidance prior to entrance to market. The company offers a variety of in vitro safety assessment studies for drug candidate evaluation, as well as an extensive selection of products for drug metabolism and pharmacokinetic research.