CARBOGEN AMCIS SAS is a leading company in the manufacturing of sterile Investigational Medicinal Products (IMPs) based on complex compounds. Established in Riom, we are part of CARBOGEN AMCIS Company.

We offer a comprehensive range of services for the development and for contract manufacturing of sterile lyophilized and liquid dosage forms for New Molecular Entities (NMEs) for preclinical and clinical studies.

With our unique isolator technology, we have gained a high level of experience, working for the last 15 years with a wide range of drugs including small molecules, peptides, enzymes, therapeutic proteins and nanoparticles.

Our highly trained and experienced staff operates in state-of-the-art containment facilities and can handle materials of the highest occupational exposure band, including cytostatics, cytotoxics, hormones, non-Beta lactams antibiotics and Antibody Drug Conjugate (ADC).

We offer full services with high level of project management including:

• Development activities:
  • Formulation, process and lyophilization cycle development
  • Scale-up from laboratory scale
  • Definition of cGMP process
• Capacities to implement a formulation process under aseptic conditions
• Manufacture of Liquids or lyophilized drug product in vials or syringes
• QC analytics (physicochemical and microbiological)
• Stability studies (ICH conditions)
• Qualified Person release
• Regulatory Affairs

Isolators’ line associated to a lyophilizer	Work in aseptic filling isolators – Classe A
Learn more about our formulation and aseptic production of drug products:

In addition, the rest of CARBOGEN AMCIS organization provides worldwide a full range of services for the synthesis of the Drug Substance including:

• Process development from first time scale-up to commercial manufacture, production from gram to several hundred kg scale,
• 70 multi-purpose reactors ranging from 6L to 6.300L,
• Extensive capacities for Highly Potent APIs manufacture – Capability to handle up to category 4 + compounds (down to 0,05g/m3),,
• Chromatography platform, solid state investigation and crystallization development,
• Dedicated laboratory for Bioconjugation and the cGMP Manufacture of ADCs,
• Manufacturing capacities in eightdifferent site (Switzerland, UK, France, The Netherlands and China).

Please do not hesitate to contact us to discuss the details of your project.

Find out more about Carbogen Riom:

Website: https://www.carbogen-amcis.com/
Email: drugproduct@carbogen-amcis.com

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