COMSER launches LyoFlow® on the market: a disruptive system that represents a new paradigm in the development of the lyophilisation processes for new injectable drugs.
On the one hand, the exponential growth of new drugs of biological origin, based on increasingly complex and unstable molecules, has highlighted the importance of stabilisation processes whose objective is to extend the life of the drug, facilitating its distribution worldwide.
On the other hand, the most important regulatory agencies in the world, such as the FDA (USA) and EMA (EU), encourag the pharmaceutical sector to deepen the knowledge of the processes, through analytical technology tools, to enhance the detection of quality issues in the product during the manufacturing process and, thus, ensure that drugs meet the desired attributes.
In this context, COMSER, a company from Barcelona, highly specialsed in services for the development and manufacture of lyophilised injectable drugs, is launching an innovative technology to monitor product quality during the process.
LyoFlow® has been developed by COMSER, within the framework of a research project initiated five years ago. The project has been funded by the Centro para el Desarrollo Tecnológico y la Innovación (CDTI) of the Spanish Ministry of Science and Innovation. The technology developed and its application are registered under patent.
This innovation responds to one of the most demanded technological needs of recent times in the field of process development. The solution will be presented exclusively to LyoHub the 12th of October, a North American lyophilisation research group in which the world’s leading universities and pharmaceutical laboratories in the biopharmaceutical sector participate. In addition, on 24, 25 and 26 October, the system will be presented at the CPHI Worldwide trade show in Barcelona.
The most important companies in the pharmaceutical and biotechnology sector will be present. The event brings together more than 30,000 industry professionals and 1,500 exhibitors from all over the world.
LyoFlow® is a disruptive solution that makes the obtention of the mass flow of a freeze-drying process in real time in a non-invasive way possible. It can be easily implemented on almost all existing freeze-drying equipment (laboratory, pilot or industrial equipment). The system is equipped with an intelligent software, which manages mass flow information and other process parameters to create a three-dimensional design space, which monitors product quality in real time.
The presentation of this system represents, for COMSER, a giant step forward in the consolidation of the company’s purpose as a service company to speed up the industrialisation of pharmaceuticals. It also represents a firm step forward in its positioning as a world leader in the formulation, development and scale-up of lyophilisation processes for injectable medicines.