BUBENDORF, Switzerland (February 16, 2018) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced today that its Vionnaz site has successfully completed a Swissmedic inspection.
Swissmedic conducted the inspection (general surveillance audits) over two days, on December 12-13, 2017 at CARBOGEN AMCIS’ Vionnaz site. The inspection covered the Quality System related to the development and manufacture of highly potent APIs, including Analytical and Quality Control. No significant concerns were discovered during the inspection, which will result in the renewal of the GMP-certificates for the site.
The high potency facility in Vionnaz is designed to operate at an occupational exposure limit (OEL) level down to 0.05μg/m3. CARBOGEN AMCIS acquired the facility in August 2014 to significantly increase the development and manufacturing capacity of highly potent APIs. This site has already demonstrated the capability to produce highly potent warheads and linkers, which can be transferred to our bio conjugation facility in Switzerland to create Antibody Drug conjugates (ADC) for cancer treatment therapy.
“This inspection follows the first audit by Swissmedic in 2016 for the cGMP certification after we acquired this site,” said Martin Schneider, Chief Quality Officer at CARBOGEN AMCIS. “This successful inspection underscores CARBOGEN AMICS’ track record of high quality development and manufacturing. Our other facilities in Switzerland also successfully passed a series of audits last year; FDA audit in October 2017 for the Bubendorf (Headquarters) and Swissmedic inspections for the sites in Bubendorf, Neuland and Aarau in July 2017. This proves our commitment to consistently fulfill the highest quality requirements for all of our sites”.
“I am proud of what the Vionnaz team has been able to achieve with support by our expert groups in Switzerland. Demonstrating to Swissmedic its capacity to meet all aspects of quality is a significant accomplishment,” said Mark Griffiths, CEO, Dishman Carbogen Amcis group. “This facility was acquired more than 3 years ago to extend our Antibody Drug Conjugate Services and increase the development and manufacturing capacity of highly potent APIs. I am delighted of this successful integration that meets the constantly growing demand of our customers.”
CARBOGEN AMCIS AG (www.carbogen-amcis.com) 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 Carbogen Amcis Limited., Ahmedabad, India.
Dishman Carbogen Amcis Limited (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India.