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EU PROJECTS

 

 

"Expansion of the Research and Development Center OF Mabion SA - research on a new generation of drugs"

 

 

Based on the co-funding agreement No. POIR.02.01.00-00-0214/17-00 of 11 June 2018 Mabion Spółka Akcyjna implements the Project: "Expansion of the Mabion S.A. Research and Development Centre - research on a new generation of drugs" under Measure 2.1 Support for investments in R&D infrastructure of enterprises of the Smart Growth Operational Programme 2014-2020 co-funded by the European Regional Development Fund (hereinafter: ERDF).

The subject of the project is the development of the Company's research and development base by preparing the necessary infrastructure: the building of the Research and Development Centre and the acquisition of research equipment for conducting research on innovative drugs.

The effects planned to be achieved are the development of the Company's research and development base. The designed Research and Development Centre will serve the development and preparation for commercialization of the latest generation of biotechnological drugs, monoclonal antibodies.

 

The value of project: 172 876 340,70 PLN

The value of eligible costs: 140 549 870,50 PLN

Value of ERDF co-funding: 63 247 441,60 PLN

Implementation: 2018.01.20 – 2021.12.31

 

Project office:

Małgorzata Łuszczyńska, Adam Szafrański

m.luszczynska@mabion.eu; a.szafranski@mabion.eu

+48 42 207 78 90

Mabion S.A.

ul. gen. Mariana Langiewicza 60

95-050 Konstantynów Łódzki

 

 

 

 

"Development and scaling up of an innovative production technology of a therapeutic, recombinant monoclonal antibody, in order to launch commercial manufacturing process of the first Polish biotechnological drug product for oncologic and autoimmune therapies"

Project co-funded from the resources of the Smart Growth Operational Programme 2014-2020, under Measure 1.1. "R&D projects of enterprises", Sub-measure 1.1.1 "Industrial research and development works carried out by enterprises"

The aim of the Project is to conduct development work aimed at preparing the implementation for the production on an industrial scale of the globally innovative MabionCD20 biotechnological drug (biosimilar to rituximab), which is characterized by higher quality parameters compared to the reference drug (MabThera) in terms of purity profile.

As part of the Project, Mabion SA assumes implementing its own innovations that are unique on a global scale. We have at our disposal the first and largest biopharmaceutical plant in the world, which operates using the "disposables" technology. The company has the potential to manufacture medicinal products using a process that gives it the opportunity to gain competitive advantages, including at the level of critical quality attributes of the medicinal product (improved drug purity profile relative to reference products in terms of significantly reduced amount of protein aggregates in the final product). The effect of the development works carried out will be the increase in the production scale to commercial volumes, which will allow to produce the medicinal product in quantities satisfying market demand while maintaining a low ceiling for fixed and unit costs. It will also be proved, in analytical terms, that the parameters of the medicinal product produced today on an average scale (2x250l), which is the source of the preparation tested in a clinical trial, are consistent with the parameters of the product obtained as a result of the project implementation (scale 2x2500l).

 

The value of project: 54 188 035,17 PLN

The value of eligible costs: 54 188 035,17 PLN

Value of ERDF co-funding: 27 094 017,84 PLN

Implementation: 2016.11.01-2020.09.30

 

Project office:

Małgorzata Łuszczyńska, Adam Szafrański

m.luszczynska@mabion.eu; a.szafranski@mabion.eu

+48 42 207 78 90

Mabion S.A.

ul. gen. Mariana Langiewicza 60

95-050 Konstantynów Łódzki

 

 

"Development of biotechnological drug through development of an innovative monoclonal IgG1 subclass antibody with reduced contents of unfavorable glycoforms in relation to the referential drug – oriented against EGFR"

Project co- funded from the resources of the Smart Growth Operational Programme 2014-2020, under Measure 1.2 "Sectoral R&B Programs", InnoNeuroPharm Sectoral Program

The aim of the project is to conduct R&D work aimed at developing MabionEGFR - an innovative monoclonal antibody of the IgG1 subclass targeting specifically the epithelial growth factor receptor (EGFR) - an antibody refined in relation to the reference drug - Erbitux (international name: cetuximab). The result of the project will be both the product in the form of an antibody with increased pharmacological parameters and the process of its production, significantly different from those currently used by competitors. MabionEGFR will eventually be able to become a Polish (with global potential) medicine equivalent in terms of therapeutic benefits to Erbitux, but with an improved profile in terms of the occurrence of glycoforms that are unfavourable for the patient. The antibody developed within the project will have significant improvements over the original drug regarding the safety profile associated with a reduced number of immunogenic agents while maintaining all the therapeutic benefits of the original drug. The enhancement of the antibody safety profile will occur through optimization of the cellular host that will be used to express the cetuximab antibody. An antibody with the potential of a very attractive and valuable medicinal product with indications for the treatment of colorectal cancer and squamous cell carcinoma of the head and neck will appear on the biopharmaceutical market.

 

The value of project: 39 965 267,64 PLN

The value of eligible costs: 39 965 267,64 PLN

Value of ERDF co-funding: 28 354 422,06 PLN

Implementation: 2017.08.01-2022.07.31

 

Project office:

Małgorzata Łuszczyńska, Adam Szafrański

m.luszczynska@mabion.eu; a.szafranski@mabion.eu

+48 42 207 78 90

Mabion S.A.

ul. gen. Mariana Langiewicza 60

95-050 Konstantynów Łódzki

 

 

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