Niels Clauson-Kaas (NCK) - Pre-Clinical, Tox and cGMP Clinical Trial Materials

Niels Clauson-Kaas (NCK), located in Farum, Denmark, is an independent chemical research and development laboratory equipped with a cGMP pilot plant. NCK specialises in providing pre-clinical, tox and cGMP clinical trial materials.

Over the years, NCK has worked on approximately 1,100 projects for more than 180 customers in the US, Europe and Japan. Our focus is on timely delivery, quality and communication.

Experience in modern organic synthesis, process development and unit operations optimisation and analytics

NCK’s staff totals 26 people, of which 20 are chemists with extensive experience in modern organic synthesis, process development and unit operations optimisation and analytics. NCK’s facilities cover 1,200m² and consist of a large, well-equipped synthesis laboratory, an analytical laboratory completely renovated and expanded in 2005, and a multi-purpose, modern pilot plant operated under cGMP.

Analytical methods for in-process controls and intermediates, and validation of analytical test methods for final products

NCK has a strong analytical development group. We 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, we can either provide supporting documentation for IND filings or prepare the CMC section of the IND – whichever best fits the needs of the customer.

Multi-purpose pilot plant

NCK’s pilot plant has equipment ranging from 20l to 280l (including a 160l cryogenic reactor with -100°C capability), separated into three modular areas. NCK routinely purifies compounds using flash chromatography, in kilogram 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 programme has been audited by more than 80 QA groups from the pharmaceutical industry as well as the Danish Medicines Agency.

Synthesis of new molecular entities and validation of stability studies

We perform pilot plant syntheses of new molecular entities and develop new or modified production processes. We also offer analytical services including development and validation of analytical methods and stability studies according to ICH guidelines.

cGMP-compliant advanced stage intermediates and active pharmaceutical ingredients (APIs)

An important part of this activity consists of developing laboratory procedures which are technically feasible, safe and environmentally acceptable. Many of the products that NCK develops are advanced stage intermediates and active pharmaceutical ingredients (APIs) for pre-clinical or clinical trials produced in compliance with cGMPs.