Research at NextBioForm

Responsible: Dr. Ulla Elofsson, RISE

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.

We develop and verify novel characterisation methods for early detection and screening of degradation. In addition, we 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.

Responsible: Prof. Vitaly Kocherbitov, Malmö university

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 the research 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.

Responsible: Prof. Björn Bergenståhl, Lund university

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.

Different formulation platforms are explored for primarily local delivery. Here we focus on developing novel formulation concepts for biologics that can provide local delivery to the skin and the GI tract, and targeted delivery using a novel excipient modified recombinant silk. Local and targeted delivery is important to reduce side effects of drugs. Moving from injections to oral or topical therapy would be a huge improvement with respect to quality of life for the patient.

Responsible: Felix Runge-Roosen, Malmö University

In life science, the research using synchrotrons and neutron facilities has been more focused on active molecules than finished formulated products. Thus, there are both a need for new sample environments to meet the needs when studying complex formulations, and cases that demonstrate how these facilities can be used in industrial formulation research. Neutron and photon user facilities can provide the biopharmaceutical research industry with methods and modeling techniques to help understand the properties of complex drug formulations. Here, we use large research infrastructure such as MAXIV to understand the complex science that governs stability in biologics.