Mabion S.A.
Mabion is a European end-to-end biologics CDMO partner based in Poland, committed to providing high-quality development, manufacturing, and analytical services for biologics, biosimilars, and innovative therapies. The company emphasizes innovation, regulatory excellence, and a can-do approach to client needs, aiming to accelerate the development and commercialization of biopharmaceuticals. Mabion also actively supports oncology research through competitions and collaborations, fostering scientific advancement and patient access to new treatments.
Industries
Nr. of Employees
medium (51-250)
Mabion S.A.
gen. Mariana Langiewicza 60, 95-050 Konstantynów Łódzki, Poland
Services
cGMP manufacturing of biologic drug substances for clinical and commercial supply, including upstream and downstream production and scale‑up support.
Aseptic fill and finish operations for investigational and commercial biologic drug products in controlled cleanroom environments.
Integrated program management and technical execution from early process development through analytical characterization and clinical supply to accelerate clinical readiness.
Upstream and downstream process development, CPP/CQA definition, and scale‑up readiness with equipment equivalence and knowledge transfer to manufacturing.
Full suite of analytical services including method development, validation, routine QC, stability testing and batch release under cGMP.
Monoclonal cell line generation, clone selection, RCB and cGMP MCB/WCB creation, characterization and long‑term cryogenic storage.
cGMP manufacturing of biologic drug substances for clinical and commercial supply, including upstream and downstream production and scale‑up support.
Aseptic fill and finish operations for investigational and commercial biologic drug products in controlled cleanroom environments.
Integrated program management and technical execution from early process development through analytical characterization and clinical supply to accelerate clinical readiness.
Upstream and downstream process development, CPP/CQA definition, and scale‑up readiness with equipment equivalence and knowledge transfer to manufacturing.
Full suite of analytical services including method development, validation, routine QC, stability testing and batch release under cGMP.
Monoclonal cell line generation, clone selection, RCB and cGMP MCB/WCB creation, characterization and long‑term cryogenic storage.
Expertise Areas
- Biologics CDMO services (end‑to‑end drug substance and drug product)
- Cell line development and GMP cell banking
- Analytical method development, validation and transfer
- Bioanalysis for PK/PD and immunogenicity
Key Technologies
- Liquid chromatography (HPLC, UHPLC, SEC, WCX)
- Mass spectrometry (LC‑MS / UHPLC‑MS)
- Immunoassays (ELISA and automated high‑throughput platforms)
- Flow cytometry