Mabion is an experienced, EU-based CDMO specializing in the development and manufacturing of recombinant protein therapeutics, including biosimilars, monoclonal antibodies (mAbs), bispecific antibodies (BsAb), antibody-drug conjugates (ADCs), and protein-based vaccines. We offer a comprehensive service portfolio, including Gene-to-Vial solutions for clinical development and Commercial services such as Drug Substance (DS), Drug Product (DP), Quality Control (QC), and product release. Our capabilities are further enhanced by a broad analytical panel for detailed characterization of both DS and DP, ensuring the highest standards of quality and compliance.

Located in Poland, Mabion combines 17 years of technical excellence with EU-standard quality and regulatory compliance. What sets us apart is our ability to deliver reliable, high-quality solutions at a cost-effective price point. Mabion is a trusted partner for advancing biologic therapeutics, offering flexibility, innovation, and an unwavering focus on client success.

Type of Drugs Manufactured:

Biologics

CDMO Services:

Drug Substance Manufacturing (API);Drug Product Formulation (FDF);Aseptic Fill Finish;Research & Development;Analytical Development

No. of Manufacturing Facilities:

1

 High Potent Products capabilities:

OEB 3;OEB 4-5

Facilities Locations:

Europe

Regulatory Approvals for facilities:

EMA (Europe);ISO;GMP

Manufacturing Technologies:

Liquids;Sterile Vials

Capacity:

Mabion is a fully integrated EU-based CDMO with the capability to provide comprehensive GMP Drug Substance (DS) and Drug Product (DP) manufacturing for recombinant protein therapeutics. Our facilities and expertise enable us to support the entire development process, from cell line development through upstream processing (USP), downstream processing (DSP), and advanced analytical characterization, all while ensuring ongoing regulatory support.

Manufacturing Capabilities Include:

Cell Cultures: Expertise in both mammalian and insect cell cultures.
Bioreactor Infrastructure:
2 x 2000 L, 2 x 200 L, and 2 x 50 L stirred-tank, single-use bioreactors from Cytiva.
2 x 2500 L and 4 x 250 L orbital shaking bioreactors.
Medium and Supplement Preparation: Capacity for large-scale preparation and storage.
Cell Banks: GMP-compliant Master Cell Bank (MCB) and Working Cell Bank (WCB) generation and storage.

End-to-End Process Development:
Mabion offers expertise in the development and optimization of the entire production process for recombinant protein therapeutics, including:

Cell Line Development: Tailored to project requirements to ensure optimal yield and quality.
Upstream Processing (USP): High-performing, scalable fermentation processes.
Downstream Processing (DSP): Advanced purification technologies to achieve high-purity products.
Analytical Characterization: A comprehensive panel of analytical methods to ensure product quality, safety, and compliance.

With 17 years of technical excellence, cutting-edge facilities, and a dedicated regulatory team, Mabion is positioned as a trusted partner for biologics development and manufacturing, providing cost-effective, EU-quality solutions for clinical and commercial needs.