Establishment of the PPB method for antisense oligonucleotides (ASOs) by using the PALSAR method

Published on September 18, 2021
Biologics & Oligonucleotides
Drug Drug Interactions (DDI)
Drug Metabolism
Test Systems & Methods
Scientific Posters

Full Title

Establishment of the PPB method for antisense oligonucleotides (ASOs) by using the PALSAR^® method

Authors

Rieko Sakai¹, Takashi Yamamoto¹, Masako Osawa², Funa Ogawa², Shun Kumagaya ³, Kosuke Chiba³, Masaki Yamagami³, Takao Suzuki³, Kenta Hashizume¹
¹ ASO Development Solutions Center, Sekisui Medical Co., Ltd., 2117 Muramatsu , Tokai, Ibaraki, 319 1182, Japan
² Analytical Technology Center for ASO Development Research & Development, Sekisui Medical Co., Ltd., 3262 12 Yoshiwara , Ami machi , Inashiki gun, Ibaraki 300 1155, Japan
³ Research and Development Division, Luxna Biotech Co., Ltd., 2 8 Yamadaoka , Suita, Osaka, 565 0871, Japan

Presented at the 2021 JSSX Meeting

Abstract

Plasma protein binding (PPB) is an important parameter for drug development. According to the ICH M3 (R2), PPB of drug must be investigated before initiation of the clinical trial.

The PPB of oligonucleotide therapeutics is difficult to be evaluated because of their physical property. If the drug has high protein binding potency, it is required high sensitive and accurate detection system.

The PALSAR^® method has been developed for high sensitive analysis of oligonucleotide therapeutics [Omori A et al., 33th JSSX Annual Meeting (2018)].

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