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Highly Potent API

Highly Potent API
Product Description

CARBOGEN AMCIS has state of the art facilities and controls to handle both drug substance and drug product of the highest potency and toxicity, under cGMP. Our dedicated containment facilities use a containment methodology, utilizing barrier isolation technology and Rapid Transfer Ports (RTPs), combined with pressure cascades, airlocks and access controls. Our service portfolio starts from laboratory-scale (for process research and development purposes) up to large-scale manufacturing, in 1,600 liter vessels. These capabilities are underpinned with dedicated analytical and preparative purification technologies.

CARBOGEN AMCIS

  • CH
  • 2015
    On CPHI since
  • 1
    Certificates
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Contract Service
Primary activities
API Producer
Clinical Research
Contract Manufacturer
Contract Research Organisation

CARBOGEN AMCIS

  • CH
  • 2015
    On CPHI since
  • 1
    Certificates
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Contract Service
Primary activities
API Producer
Clinical Research
Contract Manufacturer
Contract Research Organisation

More Products from CARBOGEN AMCIS (7)

  • Analytical Services

    Product Analytical Services

    The complete integration of analytical sciences into the process of API development is fundamentally understood at CARBOGEN AMCIS. Our scientists, technique ranges, systems (including a fully validated LIMS) and procedures facilitate a full understanding of the unique characteristics of the complex molecul...
  • Clinical API Development

    Product Clinical API Development

    CARBOGEN AMCIS has a DNA in API development, stretching back over 30 years. Our API development teams are selected for their passion for science and experience in the application of phase-appropriate efforts to solve challenging chemistry issues. From taking a promising molecule from our clients' medicinal...
  • Commercialization Services

    Product Commercialization Services

    CARBOGEN AMCIS has a track record, extending over 25 years, helping our customers transition their molecules from process development through validation and ultimately into commercial status. A range of services backed up with fully integrated support functions has been developed to facilitate and smooth t...
  • Drug Products

    Product Drug Products

    CARBOGEN AMCIS has developed a comprehensive range of services for the formulation of New Molecular Entities (NMEs) and the reformulation of existing drugs. With a specialization in developing sterile and pyrogen-free parenteral formulations for preclinical and clinical trials (phases I, II and III), CARBO...
  • Sterile Drug Product services

    Product Sterile Drug Product services

    CARBOGEN AMCIS offers Sterile Drug Product services, specializing in the formulation, development, and manufacturing of injectable products. With capabilities in lyophilization, sterile filling, and handling highly potent APIs, the company ensures aseptic processing for clinical and commercial supply. ...
  • Drug Substance Services

    Product Drug Substance Services

    CARBOGEN AMCIS provides comprehensive Drug Substance services, offering expertise in process development, scale-up, and manufacturing of active pharmaceutical ingredients (APIs). With state-of-the-art facilities, the company specializes in high-potency compounds, including cytotoxics, and delivers solu...
  • Specialties Services and Products

    Product Specialties Services and Products

    Specialty manufacturing and services provided by CDMOs address the diverse needs of customers in various therapeutic, nutraceutical and dietary supplement areas, as well as in the pharma, personal care, and cosmetics industries.

    With over 70 years of experience, CARBOGEN AMCIS Veenendaal...

CARBOGEN AMCIS resources (4)

  • News CARBOGEN AMCIS Secures GMP Certification After Successful ANSM Inspection for its Aseptic Drug Product Manufacturing Site

    CARBOGEN AMCIS is pleased to announce the successful completion of the first inspection by the French regulatory authority, ANSM (Agence nationale de sécurité du médicament et des produits de santé), at its state-of-the-art sterile drug product manufacturing site in Saint-Beauzire, France.

    The inspection, conducted from January, 20th to January, 24th, follows the site’s opening in February 2023. This is the first inspection of a routine process by ANSM to ensure compliance with Good Manufacturing Practices (GMP). As a result, CARBOGEN AMCIS has been granted a GMP certificate for the Saint-Beauzire, France.
  • Video CARBOGEN AMCIS Secures GMP Certification

    CARBOGEN AMCIS is pleased to announce the successful completion of the first inspection by the French regulatory authority, ANSM (Agence nationale de sécurité du médicament et des produits de santé), at its state-of-the-art sterile drug product manufacturing site in Saint-Beauzire, France.

    CARBOGEN AMCIS has been granted a GMP certificate for the Saint-Beauzire facility, marking a significant milestone in the site's successful start-up. The certificate allows for the manufacture and release of clinical and commercial sterile drug products. The site received authorization from the ANSM to manufacture, test and release drug products from February 2023 and since then has been working under this authorization with the first clinical batch released in January 2024.
  • News CARBOGEN AMCIS announces major investments of more than CHF 100 million in Switzerland and France

    Switzerland-based CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) and drug products manufacturing company, announced today new expansion plans in Switzerland and France.
  • Brochure Company Profile

    Dowload our brochure and learn more about our offers. 
    Drug development to Commercialization services for pharmaceutical and biopharmaceutical industries at all stages of drug development

    Your CDMO from Drug Substance to Drug Product

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