Development of active ingredients
We have established the cutting-edge infrastructure required for the development of both traditional and so-called highly potent (HP) active ingredients. As for HP active ingredients, our employees work completely separated from the substances and use special gloves to manipulate the instruments and equipment — which is placed in transparent, closed isolators. The modern isolator setup ensures convenient and safe working environment, while we protect our environment with a closed system of waste collection and elimination.
Scale-up of API production
Its aim is to analyze the factors affecting the physical/chemical quality during the scale-up of the manufacturing process of the active ingredient — to study the powder technology procedures, to optimize the process and to specify the characteristics of the final product. Starting from the lab-scale batch size, the amount of substance is gradually increased up to the amount of an industrial batch — i.e. the industrial production size.
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Its aim is to analyze the factors affecting the physical/chemical quality during the scale-up of the manufacturing process of the active ingredient — to study the powder technology procedures, to optimize the process and to specify the characteristics of the final product. Starting from the lab-scale batch size, the amount of substance is gradually increased up to the amount of an industrial batch — i.e. the industrial production size.
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Drafting of the patent application
If the development results in an innovation, in a new form of active substance or in a process that is valuable from the perspective of industrial property rights, it is important to obtain patent protection — so as to increase our competitiveness.
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If the development results in an innovation, in a new form of active substance or in a process that is valuable from the perspective of industrial property rights, it is important to obtain patent protection — so as to increase our competitiveness.
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Analytical testing of active ingredients
Its aim is to analyse the chemical structure, physical characteristics, purity and stability of the selected active substance candidates, and to choose the most suitable form for further development based on these data. During the process of the active substance development, analytical methods also have to be subjected to continuous development until, in parallel with the scale-up and finalization of the manufacturing process. Finally a set of analytical methods is established that is suitable for the comprehensive description of the quality of the active substance. Those analytical methods will be used in quality control and product release.
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Its aim is to analyse the chemical structure, physical characteristics, purity and stability of the selected active substance candidates, and to choose the most suitable form for further development based on these data. During the process of the active substance development, analytical methods also have to be subjected to continuous development until, in parallel with the scale-up and finalization of the manufacturing process. Finally a set of analytical methods is established that is suitable for the comprehensive description of the quality of the active substance. Those analytical methods will be used in quality control and product release.
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Laboratory-scale development of active ingredients
Its goal is to select generic active substance candidates that are suitable for development from industrial property rights', toxicology and technological perspectives, and to develop synthetic processes for production of these active ingredients.
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Its goal is to select generic active substance candidates that are suitable for development from industrial property rights', toxicology and technological perspectives, and to develop synthetic processes for production of these active ingredients.
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Intellectual property (IP) analysis
The aim of this process is to explore the information available in professional publications, patent applications and granted patents — thus learning about the current restraints related to IP rights.
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The aim of this process is to explore the information available in professional publications, patent applications and granted patents — thus learning about the current restraints related to IP rights.
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