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Informative session on the application of NIR technology

By 21 de September de 2009November 18th, 2020No Comments
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Informative session on the application of NIR technology

An informative session on the latest developments in NIR technology (Near Infrared Spectrometry), a new analysis method to control the quality and manufacturing process of drugs for human and veterinary use, was held on wednesday, 29 September, at the Barcelona Science Park (PCB) . The great advantage afforded by the new method relies on its ability to obtain results in just a few minutes with no previous treatment of the sample or the use of reagents or solvents, with significant savings in terms of time and cost. The event was organized by Kymos Pharma Services, a company located at the PCB.

The aim of this session, titled “NIR Workshop: Innovative Solutions for Quality and Process Control” was to present the new applications of this technology, which can be of strategic importance when optimizing resources in a company, especially when new European directives are taken into account, which now require the incorporation of a content uniformity control in routine product quality control so as to demonstrate that each dosing unit (tablet, pills, sachet, etc.) contains the right amount of active ingredient. This feature will significantly increase the number of analyses routinely performed by Quality Control departments using long traditional methods (HPLC or UV) that require the use of reagents and solvents.

In addition, both the FDA as well as its European counterpart, the EMEA, have set in place a new regulatory framework that prompt pharmaceutical companies to set up Total Quality systems, which in terms of the drug manufacturing processes means the incorporation of analytical technologies that control all process stages (Process Analytical Technologies). Ii is in this PAT strategy where NIR technology becomes a key tool, since it allows controlling all process stages and detecting anomalies without having to wait for the control of the final product.

The session featured the participation of experts from the academic world and representatives from the business sector. The event also included a discussion on some practical cases from the pharmaceutical and veterinary industry that have already implemented this method. Other top participants, beside the three organising companies Kymos, dTC and Thermo Fisher Scientific, were the UAB, Bioibérica, Laboratoris Menarini and Schering-Plough.

At its laboratory, Kymos has last-generation NIR equipment together with the most conventional instrumental analytical techniques of a pharmaceutical analysis lab, needed to carry out a wide range of analytical studies related to research, the development and control of active ingredients and drugs. Other services offered by Kymos focus on the analysis of biological compounds and metabolism, as well as on technical and regulatory services of new analytical methodology.