Together we can create great things
We encourage you to take a look at our offer and if you have any questions, feel free to contact us.
We manufacture for the entire world:
Biological drugs
of recombinant
proteins class
We are engaged in the development and marketing of biosimilar drugs. These are equivalents of biological drugs already on the market. In this way, biological drugs of the latest generation, often life-saving e.g., in cancer, become more available to a larger group of patients. Our most advanced product is MabionCD20, a biosimilar drug candidate to MabThera/Rituxan. In addition, modern technological facilities and acquired competencies have allowed us to engage in a new type of projects, including production of protein vaccines.
Manufacturing and contract analytics, R&D services, regulatory support
We offer comprehensive support for the entire research and development chain: molecular cloning, recombinant protein expression development along with stable cell line development, protein purification process development, structural, physico-chemical and biological activity analytics, manufacturing scale-up, manufacturing process and analytical method validation, process control analytics, stability studies, clinical trial design, regulatory support at any stage of development.
We offer support at every stage of life science product development
We work in compliance with the following standards:
14001:2015
50001:2018
45001:2018
We are proud to tell you about our current projects
Active projects: MabionCD20
Biosimilar to the reference drug MabThera/Rituxan (rituximab), whose efficacy and safety have been clinically confirmed. We are currently preparing to market the drug in the European Union and the US in accordance with the requirements of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). This is our most advanced proprietary project.
Despite the scale of our operations, we are a close-knit team
Each area is headed by top-level professionals:
Julita
Balcerek
Head of Operations and Scientific Affairs
I provide substantive and operational oversight of projects across departments.
Marta
Bednarek
Head of Manufacturing Department
My specialty is biotechnological production:
I am comprehensively responsible for the manufacture of drug substance, followed by sterile filling, until packaging and logistics.
Dorota
Owczarek-Hamrol
Head of Quality Control Department, Qualified Person
On a daily basis I ensure the highest quality of Mabion products and raw materials used.
Łukasz
Waszak
Head of Quality Assurance Department
In our company I am responsible for the quality system and compliance of the company’s activities with the requirements of domestic and foreign regulators.
Bartłomiej
Czubek
Head of Clinical Analytical Laboratory and Medical Section
I oversee key activities in both clinical research and clinical analytics.
Edyta
Bartusik-Czubek
Head of Product and Process Development Laboratory
I am responsible for the projects from the development of a genetic construct until selection of a drug formulation for commercialization.
dr Dorota
Jaros
Regulatory Affairs
Expert
We take care of the proper development of recombinant proteins by being in constant dialogue with Regulators.
Anna
Małecka
Regulatory Affairs
Expert
We take care of proper development of recombinant proteins by being in constant dialogue with Regulators.
We have laid the foundation of the life science sector in our region.
Together with us you can co-create it.
Our Presence on the Stock Exchange
We know the value of our business
We are the first Polish biotechnology company listed on the Warsaw Stock Exchange. We operate in one of the most dynamically developing areas of the pharmaceutical sector.
List of projects implemented with European funds