SMF SweDeliver: Predicting drug absorption and immunogenicity after subcutaneous administration

Purpose and goal:

The project´s aim to establish a model for the prediction of immune responses to therapeutic proteins after subcutaneous administration has been achieved. The model includes mechanisms for the local distribution and residence time of the administered drug in the subcutaneous tissue after injection and how local immune cells respond to the presence of exogenous proteins via cell migration into the tissue and subsequent immune cascade. The model can also be applied to evaluate formulation-driven aspects.

Expected results and effects:

Pharmetheus has started to use the model for its intended purpose, i.e., to support pharmaceutical companies in decisions in the development of new drugs. Concrete questions addressed so far have concerned estimates of local tissue concentrations, absorption rate and bioavailability as well as design and evaluation of new subcutaneous drug formulations and risks when transitioning from intravenous to subcutaneous dosing.

Approach and implementation:

The project was divided into four work packages: 1. Information and Data, 2. QSP model development, 3.

PBB-QSP model development, and 4. Model evaluation. The work packages have been partly carried out in parallel and largely according to plans.

Not all stages in work package 3 and 4 have been able to be carried out as planned due to lack of available resources. The project has been performed within Pharmetheus IT environment by Pharmetheus employees and has been based on data and information from public sources.