Your End-to-End
Biologics CDMO Partner
Clinical & Commercial Manufacturing
Mabion employs the most current technologies utilizing our longtime expertise in production of large molecules. We specialize in manufacturing sterile biotechnological products in our GMP compliant facility. Our goal is to integrate science and technology to produce mammalian cell culture based biological drug substance and drug products such as mAbs, ADCs, bsAbs and vaccines. We achieve this by implementing recombinant protein processes based on various expression systems and purification techniques.
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Your End-to-End
Biologics CDMO Partner
Fill & Finish
Mabion offers GMP-compliant aseptic fill and finish services in vial format as well as secondary packaging and serialization services for a wide range of biologic products for both small scale clinical supply and large commercial manufacturing scale. We have our own warehouse and commercial vehicle fleet, which makes us independent from external vendors.
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Your End-to-End
Biologics CDMO Partner
Process Development
Our Process and Analytics Development Teams comprise highly experienced experts in upstream and downstream as well as supporting analytics. Understanding every process variable that affects the final product is the core of our strategy. Because of this, we use the QbD-based approach connected with sophisticated analytics at the very beginning of process development. Due to our extensive experience in commercial scale manufacturing, we use technologies that can be scaled up and transferred into GMP environments.
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Your End-to-End
Biologics CDMO Partner
Drug Characterization & Release Testing
Mabion offers thorough analytical testing spanning early development, comprehensive state-of-the art molecule characterization, QTPP and biosimilarity studies, as well as release/stability testing of the clinical and commercial material (DS and DP). We cover the full method lifecycle, including method development and qualification/validation. Purity/impurities testing, advanced structural characterization using mass spectrometry, glycan analyses and multiple bioassays are available at Mabion.
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Your End-to-End
Biologics CDMO Partner
Preclinical & Clinical Analytics
We are experts in developing, transferring and validating bioanalytical methods for the evaluation of pharmacokinetics, pharmacodynamics and immunogenicity of biological drugs in accordance with the relevant ICH and primary regulatory agencies guidelines (EMA and FDA). In the dedicated facility and in accordance with GCP and GLP standards, Mabion created a panel of biological methods for the analysis of samples from preclinical and clinical trials.
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Your End-to-End
Biologics CDMO Partner
Regulatory & Consulting Services
Mabion will assist you in setting your strategy for the development of biological products, including support in scientific advice meetings with EMA and FDA. To ensure regulatory compliance, we oversee operations for the development of products, analytical methods and processes as well as through comprehensive molecule characterization and documentation. We can support your regulatory operations to efficiently and quickly move your product toward and through clinical trials, and ultimately approval and launch.
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Your End-to-End
Biologics CDMO Partner
Located in the heart of Europe & EU
Our headquarters is based in central Poland, 1.5 hours’ drive from the Warsaw airport. As one would anticipate from an EU based CDMO, we guarantee the highest levels of production and analytics standards for your business. Additionally, our “can-do” approach to our clients’ needs offers solutions to unforeseen challenges which we overcome as a team.
