Carbogen Amcis to Take Over High-Containment Facility
Carbogen Amcis, Swiss-based pharmaceutical process development and active pharmaceutical ingredient (API) manufacturer, has announced plans to take over operations of a high-containment facility at Vionnaz, Switzerland, 70 km east of Geneva.
The high potency facility opened in December 2005 and was formerly managed by Bachem as an integrated part of that company's Vionnaz site. The unit is said to be cGMP-compliant and inspected by Swissmedic and by the US Food and Drug Administration (FDA).
"We are facing a significant increase in the demand for high potency services, spurred by the fast-paced growth of the antibody drug conjugates (ADCs) market, said Carbogen Amcis CEO Mark Griffiths. "The expansion in Vionnaz will ensure we can continue to fulfil customer needs and expectations while our company continues to grow and expand."
Griffiths stressed that potential customers will benefit from additional high potency capabilities available at the Vionnaz facility such as high potency laboratories, cGMP kilo-scale manufacturing, as well as larger scale lyophilisation.
Vionnaz is dedicated to the development and manufacture of highly potent APIs and can accommodate projects from gram to multi-kilo scale. The facility is completely independent and features a process development laboratory, a dedicated QC laboratory and two production units fitted with reactors up to 30 L, as well as a freeze dryer for lyophilisation and chromatography. Operations involving cytotoxic compounds are performed under containment conditions. The building is self-contained and segregated from the outside.
The substantial increase in development capabilities and manufacturing space for highly potent drugs in Vionnaz, along with the recent construction of a clean room dedicated to conjugation projects in Bubendorf, Switzerland, position the company as an outsourcing partner for complex highly potent APIs and ADCs, Griffiths said.
In the near future, the company plans to introduce additional capability for highly potent drugs at the Neuland / Hunzenschwil site to meet customer needs in chemical development and niche commercial manufacturing.
Carbogen Amcis is owned by Dishman Pharmaceuticals and Chemicals of Ahmedabad, India.
