Biological drugs – infrastructure and expertise

As a developer of biological drugs, you need to be able to prove that your drug has an expected effect on the disease or condition you want to treat, with acceptable side effects. You also need to show that the drug is stable during storage, transport and in the body, and that it always looks the same without unknown impurities. Biological drugs often have an ability to trigger an immune response, which you need to investigate; sometimes this is part of the desired mechanism of action, but you want to avoid immune reactions that could lead to lack of efficacy or serious side effects.

Many of the parameters described above need to be set early to avoid costly changes in the production process at a later stage. This is due to the fact that the production process of a biological drug is an essential part of the finished product. Finally, developers need to understand the regulatory framework, especially when it comes to therapies such as oligonucleotide drugs and mRNA vaccines that are synthetically produced but share some properties with biological drugs.

Expertise and infrastructure for the development of vaccines, antibodies, mRNA and other biologics

RISE offers expertise and infrastructure along the entire biologics development process. We can help you with:

• Analyse active pharmaceutical ingredient (API) according to guidelines (identity, purity, physical and biological properties).
• Develop appropriate formulation of the API to ensure stability, release and exposure.
• Develop methods for formulation and analyses that can be transferred to larger scale clinical trial production processes (GMP).
• Investigate how biological function is affected by the choice of production methods.
• Investigate the risk of toxicity or unwanted immune reactions.
   

RISE provides research and development laboratories for in vivo, ex vivo and in vitro experiments, as well as preclinical safety studies (toxicology) and bioanalysis GLP. We can also offer analyses within ISO 17025 accredited activities. In addition, we have GMP laboratories for clinical trial materials. 

Customised solutions ensure regulatory compliance

Often, solutions need to be customised for each specific biopharmaceutical, ensuring that all aspects that need to be answered according to the regulations in terms of specificity, mechanism of action, pharmacology, safety, as well as quality requirements around the substance and the production of the final product have been investigated. RISE has experience in all these areas and can help develop a strategy and contribute to your dialogue and documentation to authorities.