Under the terms of the agreement, contract research organization (CRO) SYnAbs will develop an immuno-assay in order to measure features of a biosimilar monoclonal antibody developed by Univercells.

The aim of the collaboration is to test the batch-to-batch variability of the biosimilar from Univercells and to confirm its biosimilarity compared to the originator biological. In order to do this SYnAbs will develop a custom enzyme-linked immunosorbent assay (ELISA), which it says will be a sandwich-type enzyme immunoassay ELISA in which the biosimilar binds to the antigen on the microtiter plate and a biotinylated anti-idiotype antibody recognizes the complex.

The recognized antigen will be produced in an Escherichia coli (E. Coli) expression system by RD Biotech – SYnAbs sister company, based in France. SYnAbs will then determine the best conditions for the antibody pair and will optimize the different features of the assay, including but not limited to, the best suited ELISA plate, coating conditions, denaturing agents, antigen and antibody concentrations, and incubation time.

At the end of the process, Diaclone – another sister company of SYnAbs, also based in France – will then perform a bioassay efficacy testing in order to check the antibody activity on cells through EC50 measurement.

Back in January 2018 Univercells received a grant worth Euros 2.4 million (US$2.9 million) from the Wallonia Region (Service public de Wallonie - Direction générale opérationnelle de l'Economie, de l'Emploi, de la Formation & de la Recherche [DGO6]). This funding was given in order to enable the company to launch a programme aimed at the development of its innovative protein platform, paving the way for the cost-effective production of biosimilars. The company also raised Euros 3 million (US$3.56 million) capital in a Series-A equity financing round, led by private investors and has received a US$12 million grant from the Bill & Melinda Gates Foundation and Euros 3 million from Takeda.

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