The SCISSOR technology: Investigating Biopharmaceutics of Subcutaneously Delivered Oligonucleotides

Although subcutaneous (SC) injection is the major route of administration for oligonucleotides (OGs), biopharmaceutics knowledge for this modality is limited. There are no standardised in vitro tools for accurate prediction of OG absorption kinetics from the SC injection site. The aim of this study was to investigate release in vitro using the SC injection site simulator (SCISSOR) and make the first reported attempt to link in vitro OG release profiles to in vivo pharmacokinetic (PK) data. In vitro-in vivo relationship (IVIVR) was explored using deconvolution and a Levy plot approach [1-4].