We offer custom development and automated aseptic production of liquid and lyophilized drug products, with a specialization in developing sterile and pyrogen-free parenteral formulations for preclinical and clinical trials (phases I, II and III) and small scale commercial. With this end-to-end service, CARBOGEN AMCIS is your partner of choice for complex and demanding products that require the highest level of quality in our industry.
With over 20 years of experience, we have the necessary skills and ability to safely develop liquid and lyophilized pharmaceutical forms, for a wide range of indications and varied drug delivery systems. Much of our experience is in the area of highly potent drug products and antibody drug conjugates (ADC), both addressing the rapidly growing oncology sector. At both out of drug product manufacturing sites, our disciplined and experienced staff manufacture materials of the highest occupational exposure (single-digit nanogram levels), including cytotoxics and cytostatics. CARBOGEN AMCIS is a new state-of-the-art facility which has two fully automated aseptic filling lines for drug product.
of experience in fill & finish
of projects are HiPo formulation
In February 2023, CARBOGEN AMCIS opened a new manufacturing facility dedicated to the custom development and production of sterile injectable drug products. Built on newly acquired land and located only 7km from CARBOGEN AMCIS’s drug product manufacturing site in Riom, this new facility increases product development and manufacturing capacity for liquid and freeze-dried products for pre-clinical and clinical trials and enables us to collaborate with our clients through to commercial manufacture. Importantly, this new facility enables CARBOGEN AMCIS to offer complete end-to-end service provision for sterile, injectable drug product: from formulation development through to supply of commercial drug product.
The all-inclusive facility contains:
Our service offering includes the formulation and development of injectable drug products in both liquid and lyophilized forms including highly potent biological drug products.
CARBOGEN AMCIS has a full suite of formulation and process development capabilities for parenteral formulations; including small molecules, cytotoxics, proteins, peptides, enzyme inhibitors, antibiotics (non beta-lactam), vaccines (non-live), mAbs and antibody drug conjugates (ADC), providing:
Consistently applying current Good Manufacturing Practices (cGMP), CARBOGEN AMCIS is proud to provide services that can enable fast supply of pre-clinical and clinical batches of liquid or lyophilized injectable drug product for use in clinical trials and low volume commercial supply. Aseptic filling is available in a wide range of volumes in vials, syringes and cartridges.
Clinical and Commercial Batches