The Department of Functional Materials and Catalysis invites to a guest lecture by Eva Roblegg, Pharmaceutical Technology and Biopharmacy, Institute of Pharmaceutical Sciences, University of Graz:

Title: "Cell-based in-vitro models for the rational design of drug delivery systems produced by advanced manufacturing"

Nano drug delivery systems (NDDS) have proved to be advantageous for solubilizing drugs, protecting them from enzymatic degradation and administering them intracellularly. However, their rational design remains a challenge, as the translatability of production processes from laboratory to industrial scale must be ensured, since even the smallest changes in the manufacturing process can significantly affect the physico-chemical properties of the nanocarriers, leading to altered therapeutic effects. Currently, industrial production of NDDS is based on time-consuming and error-prone multi-stage batch processes that are costly, difficult to scale up and difficult to control. In addition, a lack of process understanding of the individual production steps and the missing or inadequate control of influential process parameters and product quality pose the risk of producing products of poor quality and safety. Furthermore, too little is still known about the biological processes of the respective barriers that NDDS encounter during administration. The reason for this is that in vivo animal models often do not reflect the physiology of humans. Accordingly, the development of cell-based in-vitro models for testing drugs and NDDS is being pushed forward by the drug authorities.

In the first part of the talk, the development of NDDS will be elucidated using the example of nanostructured lipid carriers produced in a recently developed semi-continuous top-down production process. Furthermore, it will be discussed how these nanocarriers interact with human biological barriers, taking into account critical parameters such as composition, internal structure or size. In the second part of the talk, the biopharmaceutical cell-based barrier systems will be presented in more detail. In particular, oral mucosa and small intestine models will be discussed, which are used to investigate toxicity, interactions or permeability of (N)DDS and innovative drug candidates.