Formulation of biologics

Formulation development for biological substances like proteins and bacteria requires a constant awareness of how to maintain the biological function. At RISE, we are experienced in working with biologically active substances and we know what factors that may affect their function.

Unique needs for unique substances

Biological substances are often complex and sensitive structures with unique properties that has unique needs for formulation and handling. Incorrect handling can induce aggregation and degradation. That types of challenges are common during development of drugs based on biological substances. Regardless if the substances is a small protein like insulin, or if it is a whole bacterial cell like in probiotics, the challenge is to create a product that is easy to use, has a long shelf-life, and with a maintained protein- or cell function.

The formulation work and the analysis methods need to be adapted to the type of biological substance. At RISE, we solve this by combining deep knowledge on biomolecules, access to a wide range of analysis equipment, and a problem-solving mindset.

The molecular interactions are playing a key role

The primary goal in formulation development is to find the conditions in which the biological substance has a good stability. Such conditions can for example be how the sample is stored or which ingredients that stabilizes the substance. The interactions between the active molecules or cells, with other components in the formulation or with material surfaces (adsorption), can induce aggregation which in turn can lead to a loss of active substances in the formulation. Such interactions and the effect of them can be studied both in solutions and at surfaces, and it is relevant for example when choosing a suitable material as storage container for the substance.

We are experienced in work with liquids, semi-solids and solids. Some examples of the type of properties we can study are: adhesion, foam formation, aggregation, chemical degradation, encapsulation and release, and how different freeze-drying protocols affect the biological substances.

An experienced partner

RISE is an experienced partner for formulation development of biological substances. In the EU-finansed project FORMAMP, we coordinated the work where new formulation for antimicrobial peptides were developed, and their activity were studied after being encapsulated and released from different delivery systems. Currently, we are coordinating a research consortia called NextBioForm, with academic and industrial partners. The project targets formulations that improves the stability of protein drucs and probiotics. Another example is the project AquaHeal in which we aim to construct a medical device that contains biologically active salmon roe. We study the release of a roe extract from 3D-printed wound patches and evaluate the positive effects of the released substances on wound healing.