The research within NextBioForm is devided in three work packages with overlapping interests.
Work package 2 – Innovative formulation designs for solids
Work package leader: Vitaly Kocherbitov (MAU)
Work package 3 – Novel formulation platforms
Work package leader: Björn Bergenståhl (LU)
Long term stability of liquid formulations is a central aspect of the development and production of biologics. Destabilisation may lead to chemical degradation and physical changes. Increased stability, especially at room temperature, will make it possible to develop drugs with higher patient compliance, preventing risk of activity loss of the drug and the formation of hazardous contaminations such as protein aggregates.
The focus of WP1 will be to develop and verify novel characterisation methods for early detection and screening of degradation. In addition, we will study methods that can give a more detailed understanding of how aggregation occurs and what triggers can be used for accelerated studies, still preserving the correct degradation pathways.
Dry formulations of biologics are used to improve stability and allow for long-term storage also at room temperature. Selection of excipients, drying technology and residual moisture are factors that influence the integrity of the active ingredient, and the structure of the formulation.
The focus of WP2 is the intimate interplay between water and the excipients in a solid state formulation. These different factors contribute to the stability of the active ingredient and are thus important to investigate and understand.
Different formulation platforms are explored for primarily local delivery. Novel formulation concepts for biologics that can provide stability, targeted delivery and improved functionality for the patient.
The focus of WP3 is to developing novel formulation concepts for both proteins and novel biologics such as bacteria. The formulation structure before and after administration, release properties and protein/probiotic stability will be addressed throughout, and the biological effects will be evaluated using in-vitro and in-vivo models.