The inspection, conducted 12–13 December at the Carbogen Amcis' Vionnaz site, covered the quality system related to the development and manufacture of highly potent active pharmaceutical ingredients (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 0.05 μg/m3.
Carbogen Amcis acquired the facility in August 2014 to significantly increase the development and manufacturing capacity of highly potent APIs.
The site has already demonstrated the capability to produce highly potent warheads and linkers, which can be transferred to its 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 Amcis’ 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 fulfil 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.”
