Take your project to the next stage with drug product development and sterile manufacturing with CARBOGEN AMCIS
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. 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:
- Two Research and Development Laboratories
- Two Quality Control Laboratories: microbiology, physical & bio-chemical
- Two manufacturing suites offering both liquid and lyophilized finished drug product
- Comprehensive utility services, all purpose built, including logistics, utilities, maintenance and engineering, project management and administration
- State-of-the-art equipment with the ability to add project or client specific upgrades for bespoke manufacturing
- Automated visual inspection
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:
- Formulation of new products
- Optimization of existing formulations
- Development and optimization of lyophilization cycles
- Process development and scale-up for liquid or freeze-dried formulations
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.
Our service offering includes:
- For use in analytical testing or development, or for stability and toxicology studies as required.
Clinical and Commercial Batches
- Bespoke project projects with qualification of aseptic process via media fill testing
- Phase I, II, III and commercial
- Process validation batches (PPQ)
- Commercial manufacture to fit forecasting requirements
- QP certification by in-house QP