10 street Balls, 63200 RIOM, France
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).
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 personnel 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 more recently Antibody Drug Conjugate (ADC).
We routinely supply medication for clinical trials to our (bio) pharmaceutical customers.
We offer a full services including:
• Development activities:
- Formulation, process and lyophilization cycle development
- Scale-up from laboratory scale
- Definition of cGMP process
• Implementation of a formulation process aseptically
• Manufacture of Liquid or lyophilized drug product in vials or syringes
• QC analytics (physicochemical and microbiological)
• Stability studies (ICH conditions)
• Qualified Person release
• Project management
|Isolator's line connected to a lyophilizer||Capping and crimping - under class A environment|
In addition, the rest of CARBOGEN AMCIS organization provides 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
• multipurpose reactors 70 from 6 8L to 000L
• Expanded capacity for the production of active principles requiring containment until 4 + category (up to 0,05 μg / m3)
• Chromatography platform, Solid state investigation and crystallization development
• Dedicated laboratory for Bioconjugation and cGMP Manufacture of ADCs
• Manufacturing Capabilities in 7 different production sites (Switzerland, England, France, China and India)
Please do not hesitate to contact us to discuss the details of your project.