Cutting edge API development
NCK provides cutting edge process development and API manufacturing for biotech and pharmaceutical companies who want to take NCEs from discovery to commercialization.
Our clients benefit from more than 60 years of experience based on strong theoretical knowledge combined with outstanding skills for applied chemistry.
Our in-house designed project management system supports a rapid and smooth project progression throughout all stages in an open and transparent environment, where all information is exchanged via the project manager.
NCK’s well-integrated project management system ensures that all projects meet client expectations on time and on budget.
Seamless project progression conducted by project manager
NCK is a project oriented organization, and we aim at setting the highest standards within the industry. Over the years we have developed and continuously perfected the way we conduct and manage projects in order to minimize risks and increase predictability.
We prefer to offer all clients a single point of contact. The project manager facilitates communication between the client and our team to ensure a uniform and transparent exchange of information.
The project manager, who is always an experienced chemist, has the overall responsibility from the very start of a project right until delivery of the finished product. This ensures a seamless and agile flow throughout all process steps.
The project manager takes care of all contact with the client and facilitates exchange of relevant information. This ensures that all phases in any given project are carried out timely, with professionalism and a keen eye for details in order to meet the highest quality standards.
Throughout all projects, the project manager keeps the client well informed with written progress reports and teleconferences on a regular basis.
Tap into +60 years of experience based on +8,700 in-house conducted reactions
NCK has a well-equipped, state of the art synthesis laboratory used for conducting process development and small-scale, non-GMP manufacture.
Our lab consists of fume cupboards, walk-in hoods, and contains equipment of up to 20 L reactor size.
Our team consists of highly professional chemists, all holding Masters or Ph.D. degrees in chemistry, and the average experience within the group is +15 years in the industry.
For the past 60 years, NCK has developed a vast knowledge pool within the area of organic chemistry, and our internal system setup safeguards all information.
All lab notes throughout the years are stored in our central archive, and through our own reaction database, consisting of more than 8,700 reactions conducted in-house, we have easy access to valuable references of previously developed chemistry.
Development, validation and tests in alignment with ICH-guidelines
We experience an increasing demand for analyses, and our highly skilled QC team consists of analytical chemists and laboratory technicians.
NCK runs a state of the art analytical laboratory, which includes HPLC (DAD, ELSD and CAD), IC, GC and LC-MS (QTOF). In connection with process development and API manufacture, NCK offers development and validation of analytical test methods as well as stability studies according to ICH guidelines.
Our analytical laboratory is constantly being updated to meet industry standards and client expectations.
The analytical services include: method transfer, method development (HPLC, LC/MS, IC and GC), drug substance release testing, impurity profiling, method validation according to ICH guidelines as well as genotoxic impurity investigations e.g. test methods for low quantity determination.
Pilot plant operated under GMP and NCK’s SOP system
NCK has its own multi-purpose pilot plant operated under Good Manufacturing Practice (GMP).
The pilot plant consists of five production lines equipped with glass or glass-lined reactors, ranging from 40-280 L (-20°C to +150°C ) plus a 160 L steel reactor used for cryogenic reactions (-80°C). In addition to traditional chemistry manufacturing, NCK has a vast experience with downstream purification using both normal phase chromatography (flash) and low pressure, reverse phase chromatography (LPLC).
The pilot plant consists of three production rooms, two drying rooms, several storage areas and utility rooms. The pilot plant is staffed with a highly experienced team.
When a project is transferred from the laboratory to the pilot plant, the responsible project manager actively participates in the transfer and production and has the overall responsibility.
The pilot plant work is performed under our SOP system, e.g. controlled production documentation and Quality Assurance involvement, including equipment cleaning verification, training, auditing, release/approval decisions and investigations.
Quality Assurance and Quality Control functions are important parts of our GMP system
Most of our projects involve either manufacturing of advanced stage intermediates or Active Pharmaceutical Ingredients (APIs) for pre-clinical and/or clinical trials, produced in accordance with cGMP.
NCK is committed to operating in compliance with GMP as defined by the ICH Q7 GMP Guide for APIs, and rules Governing Medicinal Products in the European Union, Vol. 4, Part II, concerning APIs for use in clinical trials.
Appropriately staffed Quality Assurance and Quality Control functions are important parts of our GMP system. Our Quality Assurance activities comprise our internal SOP system, e.g. training of personnel, controlled production documentation and release/approval decisions and investigations. Our system is constantly being updated, through client audits, for example. More than 80 external QA groups from the pharma and biotech industries have audited our QA system over the past 25 years.
NCK holds a GMP Certificate issued by the Danish Medicines Agency
NCK offers a list of non-GMP items from stock
NCK has a long tradition of working with substituted furans and pyridines as well as pteridine analogues, and offers a number of advanced building blocks in this area.
Within this area, we offer chemicals in quantities from gram to kilogram.