CARBOGEN AMCIS SAS is a leading company in the manufacture of injectables. We offer a full range of services for freeze-dried and liquid formulation development as well as batch manufacturing for preclinical and clinical studies.
Thanks to our unique insulator technology, we have gained a solid experience working since the last 15 years with a wide range of complex active ingredients including cytotoxic agents, peptides, enzymes, monoclonal antibodies, ADC, and nanoparticles. Our highly qualified and experienced staff operate in state-of-the-art containment facilities, allowing them to safely handle highly active materials such as cytostatics, cytotoxic hormones, antibiotics and more recently ADCs - Antibody Drug Conjugate.
We offer a full services including:
• Development activities:
- Formulation and development of the lyophilization cycle.
- Scale-up from laboratory scale to clinical production
- Definition of a BPF 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
|Line of insulators associated with a freeze-dryer||Closing 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 capabilities for production of active ingredients requiring containment up to 4 + (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.