Analysis Biomolecular Interactions of Protein Antigens and SPA09 by BLI (CAT#: STEM-MB-0102-CJ)

Introduction

Vaccine antigens produced in the form of highly purified subunits, recombinant proteins, or synthetic peptides, generally require an adjuvant help to induce the adequate immune response. For the development of such adjuvanted vaccines, it is important to devise an appropriate characterization package to understand the critical quality attributes essential for their stability, safety, and efficacy. The characterization of vaccine antigen – adjuvant interactions is not only an important piece of this characterization package but also a regulatory requirement. Sanofi recently introduced a novel polyacrylate adjuvant, 'SPA09' , based on a linear high molecular weight acrylic acid polymer. This linear (i.e. non-crosslinked) polyacrylate demonstrated good safety, tolerability and strong adjuvant effects in mice and non-human primates. Owing to its potential advantages in terms of manufacturability, stability, and potency, SPA09 has recently entered human clinical testing. In the initial experiments describing the adjuvant activity of SPA09 with the purified recombinant CMV-gB glycoprotein antigen, strong adjuvant effects were observed while High Pressure Size Exclusion Chromatography (HPSEC) analyses failed to evidence antigen-adjuvant association.