State-of-the-art Drug Product Manufacturing Facility
Advanced state-of-the-art facilities are built to meet and often exceed regulatory standards for commercial drug product supply, such as those set by the GMP Guidelines, such as ANSM), EMA, FDA, PMDA…
CARBOGEN AMCIS sets a higher standard in the pharmaceutical industry with its state-of-the-art facility dedicated solely to producing clinical and commercial drug products. Our facility, based in Saint-Beauzire (France), is equipped with two advanced fully automated production lines under isolators tailored to meet different needs.
- Line 1 is designed for both liquid and lyophilized forms, handling vials with precision and care.
- Line 2 expands our capabilities by focusing on liquid forms in vials, ensuring versatility and quality in commercial drug supply and manufacturing.
At the heart of our operations are formulating and filling isolators that can be adapted to standard or nitrogen atmospheres, providing an uncompromised sterile environment. Our diligence extends to every detail, with Unidirectional Laminar Air Flow (UDLAF) hoods and a state-of-the-art freeze dryer equipped with Clean-In-Place (CIP) and Sterilization-In-Place (SIP) systems. To ensure sterility at every stage, we utilize a steam sterilizer, depyrogenation tunnel, and industrial rotary vial washer.
Capabilities in Drug Manufacturing
Our facility is designed for versatility and precision, with bulk formulation capacities ranging from 4 liters to 400 liters to accommodate projects of all sizes. With an automated filling line capable of processing up to 3,600 units per hour to ensure timely and consistent delivery, efficiency is at the heart of our operations.
Our state-of-the-art 10m² lyophilizer accommodates both small and large batches with a maximum capacity of 50,000 units, making it ideal for various product development and manufacturing needs. Quality assurance is an integral part of our process, so we incorporate in-line 100% weight checks to ensure the accuracy of each unit. In addition, our semi-automated visual inspection ensures that only the highest-quality products are released.
CARBOGEN AMCIS executes every aspect of aseptic pharmaceutical manufacturing with precision, efficiency and an absolute commitment to quality, making us a trusted partner in the pharmaceutical industry.
Types of Compounds
CARBOGEN AMCIS specializes in the production of a wide range of complex compounds. These include highly potent chemicals such as monoclonal antibodies, small molecules and biologics.
Our facility is equipped to handle nano- and microparticles with precision and safety in every batch. Our capabilities include synthesized peptide, proteins, and mRNA to the highest standards of quality and efficacy. We understand the critical nature of toxins and hormones and handle their manufacturing with care and precision.
Our facility also produces non-beta lactam antibiotics and antibody-drug conjugates, showcasing our wide-ranging capabilities. In addition to active pharmaceutical ingredients, we specialize in producing diluents and placebos to meet the varied requirements of clinical trials and commercial supply.
At CARBOGEN AMCIS, our ability to handle complex formulations sets us apart and makes us the pharmaceutical industry’s first choice, ready to meet the challenges of tomorrow’s medicine.
Annex 1 Compliance
Compliance with Annex 1 is essential for every pharmaceutical manufacturer aiming to produce sterile products. It is a requirement of the Good Manufacturing Practice (GMP) guidelines of the European Union (EU).
At CARBOGEN AMCIS, our robust contamination control practices, continual risk management and state-of-the-art manufacturing capabilities represent our strong dedication to complying with all European Unions GMP regulations outlined in Annex 1.
At our Saint-Beauzire site, we apply a Contamination Control Strategy (CCS) that is systematically developed to maintain the highest level of sterility through the entire drug substance manufacturing process. All of our product contact components have a single-use policy to further ensure that contamination is avoided. Each component is used once and then disposed of to prevent any risk of cross contamination.
At our Saint-Beauzire site, we apply a Contamination Control Strategy (CCS) that is systematically developed to maintain the highest level of sterility through the entire drug substance manufacturing process. All of our product contact components have a single-use policy to further ensure that contamination is avoided. Each component is used once and then disposed of to prevent any risk of cross contamination.
To reduce the risk of cross contamination we utilize Grade A isolation devices within a Grade C background for our filling procedures. The loading and unloading processes for lyophilizers operating under Grade A conditions are fully automated. We implement an approach that includes ready to use stoppers and caps along with single use pre-sterilized assemblies to maintain the highest standards of product integrity and safety, at every stage of the process.
For more information download our Drug Products brochure.
