Cristal Delivery is actively pursuing strategic partnerships with pharmaceutical companies to co-create innovative products with a clear added value to the patient. Feasibility studies are tailored to your compounds, which are either in the pipeline, on the market or shelved. Conceptually, there is a large freedom to operate with regard to system build-up, type of drug, route of administration, and disease application. Our services extend from the design phase up to the start of late-stage preclinical evaluations, all depending on the client’s request.
More specifically, a feasibility study can include the following the steps:
- Design: based on an initial assessment of the drug, we design a CriPec®-based product.
- Synthesis & formulation: the building blocks necessary to create different types of transiently stabilised drug-containing nanoparticles are synthesised. Subsequently, studies are performed to evaluated the drug release kinetics and stability of this new product.
- Animal studies: after in vitro evaluation, detailed pharmacokinetic, pharmacodynamic and toxicology studies are executed in relevant animal models to reveal the extent of sustained levels, safety and efficacy.
Go/no-go decisions are built into the process and each step is finalised by a data package and evaluated together with the client. At the end of the overall study, a full data package and report is delivered to the client, including an overview of the possibilities for further (clinical) development of the novel product. Feel free to contact us for more information about our customised feasibility studies and a detailed proposal for your compound!