CARBOGEN AMCIS, the Swiss-based pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, has announced a successful inspection by Swissmedic of its recently acquired site in Vionnaz, Switzerland.
The site has been inspected by Swissmedic and by the U.S. Food and Drug Administration (FDA) in the past and the re-audit is due to the change of ownership. The two-and-a-half-day audit covered the Quality System related to development and manufacture of highly potent APIs at the Vionnaz facility, including Analytical and Quality Control. This is the first stage in the facility’s cGMP certification process, which should be completed in the next two months.
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.
"The positive conclusion of this inspection demonstrates our commitment to the highest standards of quality across all of CARBOGEN AMCIS’ facilities,” said Martin Schneider, Chief Quality Officer at CARBOGEN AMCIS. "We acquired this site last year and, with the support of our expert groups in Switzerland, the Vionnaz team has been able to demonstrate to Swissmedic that CARBOGEN AMCIS meets all aspects of quality to supply our customers with GMP API’s from the facility. This continues our long track record of successful regulatory audits.”
“My team on-site is highly qualified with more than 10 years of experience in manufacturing highly potent APIs. Combined with our 15 years of expertise at CARBOGEN AMCIS, we managed to create really attractive synergies,” said Rolf Tunnemann, Director of CARBOGEN AMCIS Vionnaz facility. “As we move forward, we will continue to pursue opportunities to improve quality. We now have to follow the process and validate cGMP certification in the next few months.”
“I am proud of what our team has achieved in such a short length of time and delighted that we will be able to continue to support our clients growing needs,” commented Mark Griffiths, CEO, CARBOGEN AMCIS and the Dishman Group.