Dishman Carbogen Amcis (previously Dishman Pharmaceuticals and Chemicals), a pharmaceutical company based in India, has developed a high-containment active pharmaceutical ingredient (API) facility in Bavla, Ahmedabad, India.
Built at an estimated cost of $20m, the facility produces a range of oncology APIs and other associated highly potent (HiPo) products.
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Dishman Carbogen Amcis API facility details
The Ahmedabad facility is fully cGMP-compliant and has 4,300m² of operational floor space featuring development labs, kilo labs, and dedicated quality control and quality analysis facilities. Designed to manufacture HiPo APIs of less than 1μg/m³, the facility can accommodate up to four independent HiPo handling cells, with the capacity for three reactors.
There are two independent manufacturing cells at the facility. Housed on the facility’s second floor, each cell accommodates three 200l reactor vessels and 630l to 1,600l reactor vessels and has an annual capacity of 5-200kg.
The facility has a total of three floors. Arranged on the basis of flow of gravity, the ground floor is equipped with self-contained filter dryers. The 1m² filters are enclosed within a milling glove box that has the capacity for batches of up to 200 at a particle size of between 1μm and 1,000μm.
The production area also includes an analytical laboratory that characterises raw materials, vital intermediates, and final products. An energy centre equipped with a back-up power, heating, ventilation, and air conditioning (HVAC) system and a warehouse are also set up on the facility’s campus.
In addition, there is an incinerator that ensures waste is disposed of with respect to local and national requirements and in accordance with safety and environmental regulations.
Handling and containment facilities at Dishman’s facility
The facility is fully equipped to handle products with the required containment at all stages. Its cleanrooms have pressurised airlocks, pressure cascades and access controls to ensure safe handling of HiPo compounds, including cytotoxics. To facilitate loading and unloading operations with complete containment, the facility has also been installed with split butterfly valves and transfer ports of the La Calhene make.
The Bavla facility features two research and development (R&D) laboratories equipped with isolators that contain an over-tray and operate under pressure cascade. All material handling operations such as unpacking, weighing, transport, reactor charging, filter dryer discharging, and packaging are performed in isolators or glove boxes.
The facility also features three HiPo material storage areas. These are a dedicated storage room for HiPo intermediates and raw materials, a dedicated storage room for final products, and a dedicated cold storage room for potent products that need specific storage conditions.
Process transfer and manufacturing support labs are also part of the facility.
Process technology at the Dishman site
The facility uses milling technology that granulates and classifies materials to micron and sub-micron sizes in a single operation and in a single grinding chamber. The grinding system adopted by the facility delivers particle-on-particle impact. Hard wall barrier isolation technology provides several levels of engineering containment for the process.
The glove box functions at below negative pressures and under inert nitrogen atmospheres to avoid any kind of contamination. HiPo products and substances are increased in weight before being charged in the dispensing glove box, sealed, and shifted by means of rapid transfer ports in the reactor glove box.
All the analytical samples are recorded by a laboratory information management system that allows data to be accessed by project chemists at Dishman’s site in Switzerland.
The categorisation of intermediates and the final product is evaluated by the toxicology and operational health group of Carbogen Amcis, a subsidiary of Dishman Carbogen. The group performs a toxicology assessment based on occupational exposure levels or the performance-based exposure limits according to information provided by the customer.
