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Investigation of the PPB method for oligonucleotide drugs by using the PALSAR

Scientific Resources Investigation of the PPB method for oligonucleotide drugs by using the PALSAR
  • Published on August 3, 2022
  • Biologics & Oligonucleotides
  • Drug Drug Interactions (DDI)
  • Drug Metabolism
  • Test Systems & Methods
  • Scientific Posters

Full Title

Investigation of the PPB method for oligonucleotide drugs by using the PALSAR®

Authors

Rieko Sakai1, Takashi Yamamoto1, Masako Osawa2, Funa Ogawa2, Shun Kumagaya3, Kosuke Chiba3, Masaki Yamagami3, Takao Suzuki3, Kenta Hashizume1
1Drug Development Solutions Center, Sekisui Medical Co., Ltd.
2Analytical Technology Center for Drug Development Research & Development, Sekisui Medical Co., Ltd.
3Research and Development Division, Luxna Biotech Co., Ltd

Presented at the 2022 Annual Meeting of the Nucleic Acids Therapeutics Society of Japan

Abstract

The guideline (ICH M3) mentions plasma protein binding (PPB) must be studied before initiation of a clinical trial. PPB evaluation is difficult for oligonucleotide drug due to its physical properties, such as adsorption and molecular weight. As for oligonucleotide drugs with high protein binding potency, high sensitive and accurate detection system is needed to evaluate PPB at a low concentration. We have shown our developed PALSAR® method can be the best solution to seek high sensitive analysis of oligonucleotide drugs in the past. In this study, we further investigated which assay methods is the best for PPB of oligonucleotide drugs.

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