Universiteit Leiden

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Biologics Formulation

Research

An overview of the research at the Biologics Formulation group

We are using a wide variety of analytical techniques to support these studies, including separation (e.g. HPLC, asymmetrical flow field-flow fractionation), spectroscopic (e.g. fluorescence, circular dichroism), light scattering (e.g. dynamic and static light scattering) and particle characterization (e.g. flow imaging microscopy, nanoparticle tracking analysis, resonant mass measurement) techniques.

Another major challenge with biopharmaceuticals is their delivery. In most cases, the size, hydrophilic nature and instability of this class of drugs precludes the oral route as an efficient way to reach target sites. Therefore, biopharmaceuticals are usually administered parenterally via needle injection or infusion. For vaccines, it is clear that the administration route and subsequent targeting to the immune system strongly influence their safety and efficacy. We are exploring methods and formulations to deliver vaccines via the skin and mucosal routes in preclinical models. We use antigen-loaded nanoparticles to target antigens to different compartments of the immune system and to induce the desired type of immune response (e.g. humoral, cellular, tolerogenic), depending on the disease to prevent (e.g. infectious diseases) or to treat (e.g. allergy, atherosclerosis, cancer).

Current research projects

Interreg 2 Seas “Site-specific drug delivery"

 

Aim

The aim of this project is to develop innovative drug products, which are able to control the resulting drug distribution in the patient’s body: The drug amount at the site of action is to be optimized, and the amount that is “lost” into the rest of the human body is to be minimized. This is to be achieved by “site-specific delivery systems”, which release the drug at a controlled rate at the site of action. Thus, the therapeutic efficacy will be improved & undesired side effects reduced. This will help reducing the current cost burden on our healthcare systems due to adverse drug effects. Specifically, the project aims at developing innovative site-specific drug delivery systems for the colon, inner ear, peritoneal cavity and breast.

Expected results

(1) Novel drug products for a safer and more efficient treatment of patients suffering from:

    a) Crohn’s disease and ulcerative colitis

    b) Ovarian cancer with metastases in the peritoneal cavity

    c) Breast resection due to cancer

    d) Hearing loss/deafness.

(2) A novel in vitro characterization method facilitating the development of “colon targeting systems” and assuring adequate quality control during production.

(3) A feasibility study, demonstrating the performance of the newly developed drug delivery systems.

Funding

This project is funded by the Interreg 2 Seas programme 2014-2020 and the European Regional Development Fund under subsidy contract “Site Drug 2S07-033”.

Project budget: 4 885 145 €; ERDF amount: 2 931 087 €; ERDF rate: 60%

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