In addition to pre-formulation services, solid state and crystallization services, and analytical support for physico-chemical characterization and method validation, CARBOGEN AMCIS offers a complete range of formulation services for parenteral APIs and highly-potent APIs. Our formulation and aseptic drug products services are performed at our Riom, France, site, which is exclusively dedicated to the development of parenteral products and to the fast supply of batches for clinical trials.
CARBOGEN AMCIS develops sterile and pyrogen-free parenteral formulations for preclinical and clinical trials. We have over 10 years of experience with injectables, liquids and semi-solid pharmaceutical forms for a wide range of drugs, including oncology and metabolic disorder therapeutics. We can safely handle material of the highest occupational exposure band, including cytostatics and cytotoxics.
Our offerings include:
- Formulation of new products
- Optimisation of existing formulations
- Development and optimisation of lyophilization cycles
- Development and validation of analytical methods
- Pre-stability studies and ICH stability studies
- Up-scaling of formula and process
Highlights of key facilities and instrumentation:
- 2.4 square meter Glovebox for highly-potent compounds
- 0.6 square meter Lyophilizer Telstar Lyobeta 20
- Array of analytical equipment