Carbogen Amcis Plans Expansions

CPhI Worldwide, Paris (Oct. 3)-Carbogen Amcis AG (Bubendorf, Switzerland), a subsidiary of Dishman Pharmaceuticals and Chemicals Ltd (Ahmedabad, India, www.dishmangroup.com), is planning several investments in its pharmaceutical chemical development and manufacturing activities.

Carbogen Amcis will add a microreactor at its site in Neuland, Switzerland to increase the company’s capabilities for preclinical and early clinical-phase pharmaceutical chemical development. Microreactor technology uses a system of miniaturized reactors, mixers, and heat exchangers that allow for higher and more efficient heat- and mass-transfer, which in turn allows for more precise control of reactions’ conditions than do conventional reactors.

Carbogen Amcis will also add a new high potency (Category 4) analytical and quality control laboratory at is facility in Bubendorf, Switzerland. The new laboratory, expected to be fully operation by the end of 2006, will support its existing capabilities in manufacturing highly potent active pharmaceutical ingredients (APIs) at the Bubendorf site.

In addition, the company has made incremental capacity investments throughout 2006, including a new process dryer at its site in Aarau, Switzerland, a new process filter for the Neuland site, and the addition of capillary electrophoresis as a tool in its analytical development group. 

In its information technology (IT) infrastructure, Carbogen Amcis is integrating its enterprise resource planning (ERP) system at its locations in Bubendorf, Neuland, and Aarau and adding its established laboratory information management system (LIMS) to its Bubendorf site and upgrade its LIMS at its other locations.

These investments follow the acquisition of Carbogen Amcis AG by Dishman Pharmaceuticals and Chemicals in August 2006. “We are excited to be able to work with Dishman and we now have, with Dishman, the possibility to perform larger-scale non-GMP work to support early-phase synthesis and can offer large-scale CGMP manufacturing capabilities to enable customers to avoid an additional external technology transfer. This-combined with Carbogen Amcis’s preexisting, process research and development, scale-up, small-scale commercial manufacturing, and high-potency handling capabilities-means that the new organization can now service the complete spectrum of chemical development services,” says Mark Griffiths, CEO of Carbogen Amcis. “We will retain the Carbogen Amcis name and plan no major changes in staffing, management, operations or strategy for Carbogen Amcis,” adds Griffiths.

Dishman operates three manufacturing sites in India. Its Bavla site manufactures APIs and intermediates and its sites in Naroda manufacture phase-transfer catalysts, quaternary ammonium and phosphonium compounds, and select specialty chemicals.

Dishman plans to commission a pharmaceutical intermediates plant in Shanghai, China by the end of 2006 to give the company a competitive-cost position in pharmaceutical intermediates. The plant will also manufacture quaternary alkylphosphonium salts. The output of the plant will be around 3000 metric tons of quaternary alkylphosphonium salts and around 500 metric tons of pharmaceutical intermediates. The plant is scheduled for start-up in 2008