Drug Substance Manufacturing services

Drug Substance Manufacturing services
Product Description

Mabion offers advanced Drug Substance Manufacturing services encompassing various types of biologics, antibodies (including multi-specifics and ADC), fusion proteins, enzymes and vaccine antigens. Our state-of-the-art facilities offer 25L – 8000L scale GMP DS batch size for mammalian and insect cell line production are designed to meet the highest quality, consistency and safety standards. Having almost two decades of experience in biologics production from CLD through to commercial supply, we understand what Drug Substance Manufacturing looks like from your perspective. 

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Mabion SA

  • PL
  • 2023
    On CPHI since
  • 3
    Certificates
  • 250 - 499
    Employees
Company types
CMO/CDMO
Primary activities
Analytical Services
Biopharmaceutical
Clinical Research
Contract Manufacturer
End-product distributor (Wholesale)
Intermediates Manufacturer
View company profile
Categories
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Specifications
  • Selling Points
    Convenience; Experienced Technicians; International Approvals/Standards; Packaging; Price; Quality Service
  • Model
    Service
  • Supplied from
    Poland
  • Measured In
    litre
More specifications Fewer specifications
Sales Markets
Show more Show less

Mabion SA

  • PL
  • 2023
    On CPHI since
  • 3
    Certificates
  • 250 - 499
    Employees
Company types
CMO/CDMO
Primary activities
Analytical Services
Biopharmaceutical
Clinical Research
Contract Manufacturer
End-product distributor (Wholesale)
Intermediates Manufacturer
View company profile

More Products from Mabion SA (4)

  • MabionCD20

    Product MabionCD20

    This is our most advanced in-house project. A MabThera/Rituxan (rituximab) biosimilar drug, whose efficacy and safety were clinically confirmed. It is the first such advanced drug developed in Poland. We are currently at the final stage of works aimed at marketing the drug in Europe and the United States.
  • Analytical Services

    Product Analytical Services

    Mabion offers a extensive suite of Analytical Services to ensure safety, efficacy and quality of your biologic product. Our portfolio includes development, optimization and validation of analytical methods, as well as stability studies, GMP release testing and in-depth drug characterization. In addition to...
  • Fill & Finish services

    Product Fill & Finish services

    Our aseptic Fill & Finish services, in combination with our other services or offered as a stand--alone project or in combination with other services, providee a seamless transition from Drug Substance Manufacturing drug substance production to the Ffinal pProduct deliveryrelease. Our solutio...
  • Process Development services

    Product Process Development services

    Our early phase Process Development services focus on bridging the gap between lab scale and GMP manufacturing, ensuring robust scalability and outstanding productivity. In addition, based on our almost 20 years of experience, our late stage Process Development services design and execute process transfer ...

Mabion SA resources (2)

  • Development and regulation of veterinary monoclonals

    News Development and regulation of veterinary monoclonals

    Simarly to the drugs for human use, veterinary drugs must pass a strict registration procedure, both in the EU and US realms – sponsoring companies must present comprehensive evidence that they are safe and effective for use. While in the EU veterinary mAbs are approved by the EMA, in the U.S. these products are evaluated either by FDA or USDA (U.S. Department of Agriculture), depending on the intended indication.
    25 Sep 2024
  • Mabion - Your Biologics CDMO Partner: Drug Substance Manufacturing, Process Development​, Analytics, Fill & Finish​

    Brochure Mabion - Your Biologics CDMO Partner: Drug Substance Manufacturing, Process Development​, Analytics, Fill & Finish​

    With a comprehensive panel of services and fully integrated solutions, Mabion is ready to become your CDMO partner for the entire development journey from pre-clinical to GMP manufacturing. Our end-to-end offer covers every stage of this process, from gene synthesis to the final product release. With Mabion’s expertise and comprehensive services, we can bring your biologic to market rapidly and robustly.