CARBOGEN AMCIS has developed a comprehensive range of services for the formulation of New Molecular Entities (NMEs) and the reformulation of existing drugs. With a specialization in developing sterile and pyrogen-free parenteral formulations for preclinical and clinical trials (phases I, II and III), CARBOGEN AMCIS is your partner of choice for complex and demanding products, that require the highest levels of quality in our industry.
With over 15 years of experience, we have gained the necessary skills to safely develop injectables and liquid pharmaceutical forms, for a wide range of indications and varied drug delivery systems. Much of our recent experience is in the area of highly potent and antibody drug conjugates (ADC), addressing the oncology sector. Our disciplined and experienced personnel operate with state-of-the-art containment equipment; within facilities that are certified to manipulate materials of the highest occupational exposure (single-digit nanogramme levels), including cytotoxics and cytostatics. Our customer support capabilities for drug products span from pre-formulation and formulation services, to asceptic production of clinical batches. Our formulation capabilities are an integral element of CARBOGEN AMCIS’ API process, research and manufacturing services for rapid supply of product into clinical trials.
It's rewarding to be able to help manage projects and to watch them develop into the production stage successfully. Each project is unique so you're faced with new challenges to overcome each day which breaks up the daily routine.
Emmanuelle - Pharmaceutical Development Project Manager, Riom
We routinely provide Comprehensive pre-formulation work, integrated analytical and solid state services developed to provide critical information to inform on the optimal formulation strategy of drug substances, in both solution and solid states.
of experience in fill & finish
of projects are HiPo formulation
A full suite of formulation and process development capabilities for parenteral forms; including small molecules, cytotoxics, proteins, peptides, enzyme inhibitors, antibiotics (nonbeta-lactam), vaccines (non-live), mAbs and antibody drug conjugates (ADC), providing:
Current Good Manufacturing Practices (cGMP) services for the fast supply of preclinical and clinical batches of liquid or lyophilized parenterals. Aseptic filling in a wide range of volumes in vials, syringes and cartridges; from one milliliter to several hundred milliliters.
Designed for liquid or freeze-dried injectables.