Production process development for novel nasal vaccine against pneumococcal

Purpose and goal:

Abera´s vaccine platform is well suited for development of both bacterial and viral vaccines. The vaccines can be given as a nasal spray, which enable prevent of both disease and transmission.

Abera´s objective is to create a new universal vaccine against pneumococci, a bacterium that today causes approx 1.5 million deaths per year and millions of hospitalizations. The purpose of this project is to make the final preparations for large-scale GMP production and clinical studies. Expected results and effects:

In this project, through the Innovation Hub at NorthX Biologics, we want to i) produce verification batches for antigen, ii) optimize the process to connect antigen to our platform and purify the material, iii) verify the analysis methods for the material. The goal of the project is to have i) a verified production process and verified analysis methods that can be used as a basis for a regulatory proposal for clinical phase 1, ii) to be ready for GMP production of the vaccine candidate.

Approach and implementation:

In this project, together with NorthX Biologics, we will produce the various components of the vaccine and combine them in accordance with the developed production process and analyze the materials. The data will be compared with previous batches and compiled into reports that form the basis of the regulatory proposal to start clinical phase 1.