New Solution: In vitro testing for subcutaneous formulations under biorelevant conditions

20 April 2017

The scientific community is continuously looking for innovative ways to analyse compounds and formulations in a physiological and biorelevant environment. Commonly this is investigated as part of standard animal tests, and through the utilisation of ex vivo tissue preparations. Sirius Analytical now offers a different, non-animal approach to this problem – the Sirius Scissor platform.

Sirius Scissor is the first analytical instrument that successfully mimics the subcutaneous environment of the human body, in vitro, regarding its physical, chemical, and physiological parameters. It allows for the establishment of in vitro to in vivo correlations (IVIVC), formulation performance analysis (e.g. diffusion of components from the injection site and onset time) and determination of the stability upon injection of a formulation. From a formulation point of view a researcher can also assess the direct impact of a change of excipients in a quick and effective manner without using animals. The technology will enable early identification of formulations with poor performance or stability upon injection so that they can be adapted before they progress to animal studies.

Scissor has been validated with antibody formulations (kindly supplied by Genentech) and allows for an IVIVC of 90% regarding the formulations’ bioavailability. Additionally, Sirius has worked with two different insulin formulations (from Sanofi) which also show a very high correlation between human data and that obtained using our novel technology.

Sirius is now seeking partners with access to compound and formulation information (including existing preclinical/clinical data) that can be used in the instrument’s development, and to generate more data to further validate the Scissor platform with different types of formulations (e.g. peptides, coagulation factors).

Visit the CRACK IT Solutions website to find out more and to contact the Solution provider.