Facility expansions and enhancements benefit HiPo customers26 September 2008
BUBENDORF, Switzerland - Switzerland-based CARBOGEN AMCIS AG has made a number of capital investments this year, with the support of its parent company, Dish-man Pharmaceuticals & Chemicals Ltd. Capital expenditures will total $25 million by the end of the fiscal year in April 2009.
As announced earlier this year, the company’s Indian subsidiary, CARBOGEN AMCIS INDIA Limited, is building a high-potency facility at Dishman’s headquarters near Ahmedabad, India. The facility, a state-of-the-art, 4,300-square-meter plant catering to cytotoxic and non-cytotoxic highly active substances, will be one of the largest and most flexible custom-manufacturing high-potency facilities in the world.
“The addition of the plant in India offers customers a seamless approach to high-potency re-search and development, process optimization and commercial manufacturing,” said Rhona McIntyre, commercial director, CARBOGEN AMCIS AG. “The different locations and infrastruc-ture provide options to maximize speed, flexibility and cost advantages with the same safety and quality standards throughout. The new facility in India will enable customers to solely col-laborate with CARBOGEN AMCIS as a technical partner from early stage route development to market supply without volume limitations.”
With an operational floor space of 4,300 square meters, the Bavla facility will have its own dedicated utilities. Designed using the established principals at the company’s existing Buben-dorf facility in Switzerland, the Bavla complex will exercise the same advanced safety and envi-ronmental protection. The facility in India will operate as category 3 (OEL<10?g/m3) and cate-gory 4 (OEL<0.1µg/m3) facilities. Four segregated high-potency cells will each be fitted with three reactors and a filter dryer. Reactor sizes will range from 630 to 1,600 L and will comple-ment the existing category 3 and 4 facilities in Bubendorf. The facility will also house a number of contained laboratories, and significant additional space is available within the current building for subsequent fit-out of further high-potency manufacturing cells.
The facility is expected to be operational by mid-year 2009.
In Bubendorf, the company’s main manufacturing plant has increased flexibility with an ex-pansion of low temperature reaction capacity, along with an upgrade of the category 3 con-tainment area. More vessels are now available to perform low temperature reactions, thereby freeing capacity from the low temperature/high pressure vessels in the category 3 contain-ment area.
In addition, a 30 cm chromatography column has been installed and will be operational in Octo-ber 2008, providing a long-term solution for processes, which include chromatography. To sup-port the newly installed chromatography infrastructure, the capacity of the tank farm has been expanded, assuring safe and efficient solvent handling in a dedicated area outside the main building. This also minimizes the likelihood of environmental hazards.
At the company’s Manchester, England, facility, CARBOGEN AMCIS has invested in a new kilo-lab, affording 2 x 30 L glass vessels and a new 46 cm diameter chromatography column holding 100 kg of silica gel. Both enhancements have been installed and are operational, en-hancing CARBOGEN AMCIS’ ability to rapidly deliver small-scale non-GMP material to support pre-clinical studies.
CARBOGEN AMCIS AG is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development allowing customers to make the best use of available resources.
CARBOGEN AMCIS AG is owned by Dishman Pharmaceuticals and Chemicals Ltd., Ahmedabad, India.
Source: CARBOGEN AMCIS AG, Bubendorf, Switzerland