Niels Clauson-Kaas (NCK), located in Farum, Denmark, is an independent chemical research and development laboratory equipped with a cGMP pilot plant. NCK specializes in providing pre-clinical, tox and cGMP clinical trial materials. NCK staff totals 26 people, out of which 18 are chemists with extensive experience in modern organic synthesis, process development and unit operations optimization and analytics. NCK’s facilities of 1,200 sqm consist of a large well-equipped synthetic laboratory, an analytical laboratory completely renovated and expanded in 2005, and a multi-purpose, modern pilot plant operated under cGMP.NCK has a strong analytical development group. They routinely develop analytical methods for in-process controls and intermediates, as well as development and validation of analytical test methods for final products. NCK also supports the service for stability testing. In addition, they can either provide supporting documentation for IND filings or prepare the CMC section of the IND, whichever best fits the needs of the customer.NCK’s pilot plant has equipment ranging from 20 L to 280 L (including a 180 L cryogenic reaction with -100oC capability), separated into three modular areas. NCK routinely purifies compounds, using flash chromatography, in kg scale in the pilot plant. The finishing rooms for drying and packaging are isolated areas with HEPA filtered make-up air. The pilot plant is cGMP compliant, and NCK’s cGMP program has been audited by more than 70 QA groups from the pharma industry as well as the Danish Medicines Agency. Over the years, NCK has worked on approximately 1,100 projects for more than 170 customers in the USA, Europe and Japan. NCK’s web site at www.clauson-kaas.com also provides additional information about capabilities.Focus on timely delivery, quality and communication.
