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)
Products
Process Development
Design and scale-up of manufacturing processes supporting cell line development, upstream processing, downstream purification strategy design, and preparation for process validation.
Process Development Services
Process development services to create scalable and robust manufacturing processes for upstream and downstream biologics production.
cGMP Master Cell Banks
Generation, characterization, testing, cryopreservation, and long-term storage of eucaryotic cell banks and virus seed stocks under cGMP conditions as the starting point for GMP manufacturing.
cGMP Master Cell Banks (MCB) and cGMP Working Cell Banks (WCB)
Fully compliant services for the preparation of cell and virus banks under cGMP conditions to support biologics and cell therapy programs.
Non-GMP Research Cell Banks
Research cell banks supporting early-stage biologics development, clone selection, process optimization, and analytical studies prior to GMP manufacturing.
Non-GMP Research Cell Banks (RCB)
Multiple monoclonal cell lines created from single clones, selected and expanded to banked cell lines meeting specific quality parameters.
Process Development
Design and scale-up of manufacturing processes supporting cell line development, upstream processing, downstream purification strategy design, and preparation for process validation.
Process Development Services
Process development services to create scalable and robust manufacturing processes for upstream and downstream biologics production.
cGMP Master Cell Banks
Generation, characterization, testing, cryopreservation, and long-term storage of eucaryotic cell banks and virus seed stocks under cGMP conditions as the starting point for GMP manufacturing.
cGMP Master Cell Banks (MCB) and cGMP Working Cell Banks (WCB)
Fully compliant services for the preparation of cell and virus banks under cGMP conditions to support biologics and cell therapy programs.
Non-GMP Research Cell Banks
Research cell banks supporting early-stage biologics development, clone selection, process optimization, and analytical studies prior to GMP manufacturing.
Non-GMP Research Cell Banks (RCB)
Multiple monoclonal cell lines created from single clones, selected and expanded to banked cell lines meeting specific quality parameters.
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