EU grants

Pursuant to Grant Agreement No. RPLD.01.02.02-10-0032/21-00
dated 19 May 2022, Mabion Spółka Akcyjna is implementing a Project titled: “Development of an analytical methods panel for the characterization of immunogenicity in a clinical trial aimed at patients suffering from rheumatoid arthritis using rituximab as a drug substance” as part of the initiative Enterprise Investments in Research and Innovation under the Regional Operational Programme for Łódzkie Voivodeship 2014-2020.

The main goal of the project is to promote research and development by building and implementing a new company-wide analytics panel to assess immunogenicity of rituximab-based medicinal products as part of MabionCD20-003RA clinical trial aimed at establishing similarity between the biosimilar MabionCD20 and the original drug MabThera® (EU) and Rituxan® (USA) in patients with rheumatoid arthritis. The project will result in rolling out an innovative product solution in the form of an analytics panel service to assess immunogenicity of biological products.

Total project value PLN 3,633,337.74
Value of eligible costs: PLN 3,237,502.37
Grant amount : PLN 2,080,958.31

Project implementation years: 18 September 2021 – 30 June 2023

Contact to the project office:
Małgorzata Łuszczyńska
m.luszczynska@mabion.eu
+48 42 207 78 90
Mabion S.A.
ul. gen. Mariana Langiewicza 60
95-050 Konstantynów Łódzki

Pursuant to Grant Agreement No. RPLD.02.03.01-10-0007/21 dated 14 December 2021 Mabion Spółka Akcyjna is implementing a Project titled: “Promoting Mabion S.A.’s competitive strength by implementing a process innovation” as part of the initiative II.3 ENHANCING COMPETITIVENESS OF SMEs under the Regional Operational Programme for Łódzkie Voivodeship 2014-2020. 

The project focuses on implementing a process innovation at Mabion consisting in a validated method (the first of its kind in the Łódzkie Voivodeship and used nationwide for more than 3 years) to characterise the critical parameters of a medicinal substance (monoclonal antibody purity) in compliance with the GMP guidelines. The main objective of the project will be achieved with the use of high-efficiency and reproducible electrophoresis which will allow testing more samples compared to the traditional, less sensitive SDS-PAGE method. Moreover, the device’s compatibility with the implemented access-controlled IT system will ensure compliance with GMP. This will allow both to meet the requirements imposed by EMA and FDA and minimise process risks associated with the marketing authorisation for MabionCD20 in Europe and the United States. 

Project value: PLN 1,082,400.00
Value of eligible costs: PLN 880,000.00
Grant amount: PLN 396,000.00

Project implementation years: 1 July 2021 – 1 November 2022

Contact to the project office:
Małgorzata Łuszczyńska
m.luszczynska@mabion.eu
+48 42 207 78 90
Mabion S.A.
ul. gen. Mariana Langiewicza 60
95-050 Konstantynów Łódzki

Mabion S.A. on the basis of the Grant Agreement No. POIR.02.01.00-00-0214/17-00 of 11 June 2018 is implementing the Project entitled: “Expansion of the Research and Development Centre of Mabion S.A. – research on a new generation of drugs” under Action 2.1 Support for investments in R&D infrastructure of enterprises of the Operational Program Intelligent Development 2014 – 2020 co-financed by the European Regional Development Fund (hereinafter: ERDF).

The project aims to develop the Company’s R&D facilities by preparing the necessary infrastructure: the Research and Development Centre building and the purchase of research equipment to conduct studies on innovative medicines. The planned effects to be achieved are the development of the Company’s R&D facilities. This Research and Development Center will serve to develop and prepare for commercialization of the latest generation of biotechnology drugs, monoclonal antibodies.

Project value: PLN 172,876,340.70
Value of eligible costs: PLN 140,549,870.50
Value of EFRR co-financing: PLN 63,247,441.60

Project implementation years: 20 January 2018 – 31 December 2021

Contact to the project office:
Małgorzata Łuszczynska
m.luszczynska@mabion.eu
+48 42 207 78 90
Mabion S.A.
ul. gen. Mariana Langiewicza 60
95-050 Konstantynów Łódzki

The project is co-financed by the Intelligent Development Operational Program 2014-2020, under Measure 1.1. “R&D projects of enterprises”, Sub-measure 1.1.1 “Industrial research and development works performed by enterprises”

Information about the Project

The purpose of the Project is to conduct development work focused on the preparation for implementation for industrial scale production of globally innovative biotechnology drug MabionCD20 (biosimilar to rituximab), characterized by higher quality parameters in relation to the reference drug (MabThera) in terms of purity profile.

As part of the Project, Mabion S.A. assumes the implementation of its own innovations, which are unique on a global scale. We have at our disposal the first and the largest biopharmaceutical plant in the world, operating in disposable technology. The company has the potential to manufacture medicinal products using a process that provides competitive advantages in terms of critical quality attributes of the medicinal product (improved drug purity profile in relation to the reference in terms of significantly reduced amount of protein aggregates in the final product). The effect of conducted development works will be increasing the scale of production to commercial volumes, which will allow to produce the drug in quantities satisfying the market demand while keeping low ceiling of fixed and unit costs. Analytical comparability of the drug produced today in the medium scale (2x250l), which is the source of the preparation tested in the clinical trial, with the product obtained as a result of the project (2x2500l scale) will also be proven.

The value of the project is: PLN 54,188,035.17
The value of co-financing (contribution from European Funds) is: PLN 27,094,017.84 zł
Application documentation was developed in cooperation with the company GRUPA 4 Fundusze Europejskie Sp. z o.o.

Project office contact
Małgorzata Łuszczynska
m.luszczynska@mabion.eu
+48 42 207 78 90
Mabion S.A.
ul. gen. Mariana Langiewicza 60
95-050 Konstantynów Łódzki

The project is co-financed by the Intelligent Development Operational Program 2014-2020, under Measure 1.2 ”Sectoral R&D programs”, InnoNeuroPharm Sector Program

Information about the project

The aim of the project is to conduct R&D work aimed at developing MabionEGFR – an innovative monoclonal antibody of IgG1 subclass, directed specifically against the epithelial growth factor receptor (EGFR) – an antibody improved in relation to the reference drug – Erbitux (international name: cetuximab). The project will result in a product in the form of an antibody with improved pharmacological parameters and its manufacturing process, significantly different from that currently used by competitors. In the future, MabionEGFR will be able to become a Polish drug (with global potential), equivalent in terms of therapeutic benefits to Erbitux, but with an improved profile in terms of the presence of glycoforms adverse to patients. The antibody developed under the project will have a significant improvement, relative to the original drug, in the safety profile associated with a reduced number of immunogenic factors while maintaining all the therapeutic benefits of the original drug. The improved safety profile of the antibody will be achieved through optimization of the cell host that will be used to express the cetuximab antibody. The biopharmaceutical market will see an antibody with the potential to be a very attractive and valuable therapeutic product with indications in the treatment of colorectal cancer and squamous cell carcinoma in the head and neck region.

The project value is: PLN 39,965,267.64
The value of co-financing (contribution from European Funds) is: PLN 28,354,422.06

Application documentation was developed in cooperation with the company GRUPA 4 Fundusze Europejskie Sp. z o.o.

Project office contact
Małgorzata Łuszczynska
m.luszczynska@mabion.eu
+48 42 207 78 90
Mabion S.A.
ul. gen. Mariana Langiewicza 60
95-050 Konstantynów Łódzki

In November 2013 Mabion obtained PLN 10 million in funding to support the clinical development of the drug MabionHER2, under the Innomed program. The total cost of the Project is nearly PLN 24 million. Funds obtained from the Project are to be settled by May 2019.

PROJECT CO-FINANCED BY THE EUROPEAN UNION FROM THE EUROPEAN REGIONAL DEVELOPMENT FUND.

Measure 1.4 Support for goal-oriented projects of priority axis 1 Research and development of modern technologies of the Operational Program Innovative Economy, 2007 – 2013

Project title: “Innovative double cutting technology for obtaining modern human insulin hormone analogues”
Number of funding agreement: No UDA-POIG.01.04.00-10-010/11-00
Implementation period: 2011 – 2016
Value of the support granted: PLN 24,086,950.00

About the project:

The aim of the present project was an innovative “double cutting” technology allowing to obtain insulin hormone analogues using two proteases: enterokinase and endoproteinase Asp-N, whose proteolytic activities are fundamentally different from those of trypsin and carboxypeptidase C.

The technology to obtain insulin or its analogue using an innovative solution developed by Mabion and being the subject of a patent application, begins with the production of a precursor containing the amino acid sequence recognized by enterokinase and the amino acid sequence recognized by endoproteinase Asp-N. A bacterial host Escherichia coli strain BL21 is used to express the recombinant protein, and the fermentation process is carried out under optimized conditions to ensure efficient production of the precursor. The bacterial pellet containing the recombinant protein undergoes several steps to obtain the protein lysate fraction for the purification step, by mechanical cell damage and cell lysis. The following purification sequence of the precursor is a two-step affinity chromatography process (if it contains a sequence such as a His-tag) or ion exchange chromatography. Finally, the resulting pure precursor protein is treated sequentially with a first protease, enterokinase, and a second protease, Asp-N endopeptidase. Finally, insulin or its analogue is isolated from the reaction mixture by chromatographic separation.

The process innovation proposed by Mabion S.A., according to the adopted assumptions, can significantly influence the production cycle by increasing the efficiency of insulin analogues manufacturing in comparison to the “classical” technology of biotechnological products manufacturing, improving the quality parameters of the manufactured product and by accelerating the process of finished product manufacturing.

The application of the innovative technological process, as compared to the “classical” technology of insulin analogue production, makes it possible to reduce the drug production costs by:

• the possibility of obtaining human insulin and other analogues in a process based on a single cell culture, followed by purification of the recombinant protein in a single chromatographic process;
• avoiding the formation of insulin derivatives as contaminants when obtaining insulins formed during traditional enzymatic processing using trypsin;
• avoidance of insulin derivatives as contaminants during the derivation of insulin analogs formed during traditional, not fully-specific, enzymatic treatment using trypsin;
• the possibility of obtaining analogs having additional amino acids, including basic ones, at the ends of A and B chains without additional chemical synthesis;
• the ability to remove methionine and possible fusion peptides at the same time as removing the proinsulin C-peptide, or other peptides separating the A and B chains.

Tools:
The project work also resulted in the development of the “Enzyme Calculator for Most Optimal KEX 2 Proteolysis” available at https://enzyme-calc.mabion.eu