Vaccine development

Do you need a partner to work with to speed up your journey to a complete vaccine product? Do you need competence, advice or equipment to solve an upcoming challenge within vaccine development? As a part of RISE mission to facilitate for Swedish companies to reach clinical trials with a high-quality product, we offer expertise and collaboration possibilities within research and development. 

The new mRNA vaccines have demonstrated its efficacy, speed, and flexibility in preventing disease and further spread of the virus. Pandemic preparedness is now high on many country’s agendas and market will grow. With new vaccine modalities comes challenges in production, regulatory requirements, quality attributes, formulation, stability, and safety. Hence, your vaccine modality needs to be formulated in a stable setting that fulfil the requirements for transport, storage, and delivery as well as evoking the intended immune response and avoiding side effects caused by, for example, structural issues. RISE has a long experience with pharmaceutical development and formulation of biological drugs. We have a wide range of analytical and formulation development techniques available to ensure the identity, purity, integrity and stability of vaccines in selected formulation. If you need help with analysis during process development or to set up methods for quality control, RISE can help.

Furthermore, as a certified GLP laboratory, we can also offer immunological evaluations, safety and efficacy studies meeting regulatory criteria.

As a research partner, we work with you and our goal is to make sure your product has the best possible prerequisite to reach the market.

Exemple of the RISE offer:  

• Expertise in different vaccine modalitites such as mRNA, DNA, viral vectors, recombinant protein   
• Process development/optimization in bioreactors  
• Formulation development, lipid nanoparticles (LNPs) and adjuvants 
• Quality control of biological modalities, analytical method development, validation and method transfer
• Analytical characterization of vaccine, protein and biological products/contaminants 
• Safety and efficacy studies
• Study monitoring  
• RISE has known excellence in different administration routes, Micro-sampling techniques, anesthesia optimization and have been highly awarded internationally for animal handling (3R)  
• Immunological evaluation: flow cytometry of cell mediated immunity, cytokine profile