AMDBP – Development of a production platform for biosimilars based on CHO cells and an innovative expression system and preclinical and clinical development of a biosimilar drug based on a Fab fragment.

Funding Agreement No.: POIR.01.02.00-00-0010/17-00 under Measure 1.2: “Sectoral R&D programmes”
Date of the contract conclusion: 12.12.2017

The aim of the project is designing an innovative production technology based on CHO cells and an innovative expression system of a biosimilar drug to ranibizumab used in treatment of retinal disorders. In contrast to the reference drug available on the market (produced in a bacterial expression system), this process will be carried out in a mammalian expression system in a CHO line. The reference drug consists of a fragment of an antibody binding an antigen (Fab) obtained from the same initial mouse antibody as bevacizumab, a cancer drug available to the market. This is why the applicant envisioned its production using a mammalian expression system, which will significantly lower the costs and enhance its safety and immunogenicity while maintaining the same biological activity. The project will result in development and marketing of a biosimilar drug used in treatment of retinal disorders. Such disorders constitute an enormous social problem, especially since they often affect low income patients. The implementation of the project results will considerably decrease the price of the newest generation of drugs, thus making them more available to patients, which will translate into lower socioeconomic costs of the problem. The project will be carried out in 6 stages during 55 months.
The last stage of the project will focus on development works, i.a. clinical trials, preparing CTA documentation and marketing authorisation documents. The applicant’s in-depth knowledge and experience as well as cooperation with domestic research institutions will facilitate the completion of its aims and objectives. The innovativeness of the project results will be certified with relevant patents.
Total value of the AMDBP project:
38 366 659,20 PLN
Total value of funding: 24 783 037,60 PLN