Carbogen Amcis to open high potency facility in India
The Indian subsidiary of Switzerland-based Carbogen Amcis is planning to open a high potency facility in Bavla, India.
The Indian subsidiary of Switzerland-based Carbogen Amcis is planning to open a high potency facility in Bavla, India.
The building's framework has already been erected, and fit-out of the facility is already underway. The facility is expected to be operational by the first quarter of next year.
The facility will be located on the Bavla site of its parent company, Dishman Pharmaceuticals & Chemicals. The facility is being designed and will be operated by the Carbogen Amcis team to take advantage of the expertise and experience gained from high potency operations that already exist at the dedicated Swiss facilities.
"The Bavla facility will complement the state-of-the-art Bubendorf high potency facility. It will enable customers to work with CARBOGEN AMCIS from early stage route development to market supply without volume limitations," said Mark Griffiths, ceo, Carbogen Amcis. "Proven technology transfer procedures are already in place between Switzerland and India for non-high potency projects and will be adopted for the new facility."
The new facility will cater to both cytotoxic and non-cytotoxic highly active substances in dedicated areas and will give the company one of the most extensive and flexible custom-manufacture high potency facilities in the world.
The building will have an operational floor space of 4,300m2 and its own dedicated utilities. It has been designed using the same principles as the company's existing Bubendorf facility to ensure the safety both of the employees and the environment.
The facility in Bavla will operate as Carbogen Amcis's category 3 (OEL<10ug/m3) and category 4 (OEL<0.3ug/m3) facilities. It will hold four segregated high potency cells, each of which will be fitted with three reactors and a filter dryer. The reactor sizes will range from 630 to 1,600 litres and will therefore be complementary to the existing category 3 and 4 facilities in Bubendorf.
The facility will also have a number of contained development laboratories, and significant additional space is available within the current building for subsequent fit-out of further high potency manufacturing cells.
The Bubendorf high potency facility underwent a successful FDA Pre-Approval Inspection (PAI) audit for a highly potent active pharmaceutical ingredient in February 2008.
