Mabion Biologics CDMO
Company description
Mabion is a fully integrated CDMO for biologics, delivering end-to-end services from cell line development and scale-up to analytics, sterile fill-finish and QC release testing. We support mAbs and all recombinant proteins made in mammalian cell lines, from pre-clinical to commercial, for small to large-scale programs. Our GMP/GLP/ISO-compliant facilities in central Poland serve clients in Europe, North America, and Asia, offering flexible, cost-efficient solutions and tailored partnerships.
Company offers
End-to-end clinical and commercial manufacturing in GMP and ISO-certified (10k L);
Cell Line Development (CLD);
QbD-based process development and/or optimization;
Drug characterization (incl. analytical method development, validation and qualification in accordance with Ph. Eur. and USP requirements, QTPP, biosimiarity, stability studies) and release testing;
Pre-clinical and clinical bioanalytics (PK/PD, immunogenicity);
GMP-compliant aseptic fill and finish services in the vial format.
Company commodity
Drug Substance Manufacturing Services
Mabion offers clinical and commercial drug substance manufacturing of therapeutic proteins using mammalian and insect cell cultures, including biosimilars, innovative monoclonals, vaccine antigens and other recombinant proteins. Our main GMP and ISO-certified manufacturing facility has multiple 200L and 2000L scale stirred tank single-use bioreactor lines and 250L and 2500L orbital shaking bioreactors with independent seed trains.
Sterile Fill & Finish for Drug Product
Mabion’s Sterile Fill & Finish for Biologics services are powered by a automatic vial filling line capable of handling fill volumes ranging from 2 to 100 mL, offering unmatched versatility for a variety of biologic products. This advanced technology ensures the production of sterile products in a contamination-free environment. The filling line consists of several key components, including a vial washing machine, a depyrogenation tunnel, a vial filling line, and a VHP generator.
Process Development for Biologics
Mabion offers comprehensive process development services tailored to support the efficient and scalable production of biologics. QbD-based approach with sophisticated analytics starting from the early stages of process development, process scale-up and transfer.
Our team specializes in process scale-up, from the laboratory level through intermediate scale of 500L (if needed) until the full commercial production scales.
Photos
Fill-Finish services: visual inspection of sterile drug product vials to ensure quality and regulatory compliance.
Mabion Downstream & Purification services: chromatography-based protein purification ensuring high-quality biologics.
GMP facility with large-scale Kuhner stainless steel bioprocess equipment for biologics manufacturing services.
Mabion Manufacturing services: cGMP production team operating large-scale bioreactors under strict process control.
GMP downstream processing with automated chromatography systems for biologics purification at Mabion Manufacturing Zone.
Mabion HQ
Additional Files
Mabion Services at a glance
pdf (1,18MB )
Mabion 2025-2030 Business Strategy
pdf (1,74MB )
Mabion early stage workflow approach
pdf (989,74KB )
Pitchbook - Mabion Your End-to-End Biologics CMDO Partner
pdf (1,94MB )
Contact Information
Mabion Biologics CDMO