The aim of product development is to develop the best suited pharmaceutical formulations for patient needs.
We have product development infrastructure at our three sites (Hungary). We handle the development of liquid and semi-solid products (gels, creams, ointments, solutions, suppositories etc) at our Körmend production site — which are then manufactured in our galenic plant, at the same location. Since 2010, we have been developing various solid dosage forms at our site in Bökényföldi Street, Budapest. The medicines developed here are manufactured at industrial scale, either in the tablet manufacturing plant in Bökényföldi Street or in Körmend. We have also started developing various gels and creams at this site in 2018. At our site in Keresztúri Street, Budapest, we have established a laboratory for the development of highly potent substances, in which — similarly to our active ingredient development unit — we have created a cutting-edge working environment, where there are isolators to protect our employees and the environment.
Analysis for intellectual properties (IP)
The aim of this process is to explore the information available in scientific publications, patent applications and granted patents — thus to learn about the current state of science and the limitations related to intellectual property rights.
Laboratory-scale drug development
Its aim is to establish through small-scale experiments the dosage forms and product formulations that are best suited to the specific active ingredient(s) and therapeutic needs. The dosage form, the composition and the production technology together determine how quickly and in what quantity the active ingredient is processed by the human body. Other important aspects are the stability and shelf life of the product, as well as the primary packaging material that comes in direct contact with the medication. It is also essential to keep aspects of future industrial scale production in mind during the laboratory-scale development process.
Analytical testing of products
Its aim is to analyse the compatibility of the ingredients, as well as to test the physical characteristics, the purity, the active substance release and the stability of the formulated medication — in order to achieve the most suitable formulation(s). During the product development process, analytical methods also must be continuously developed — until a suitable set of analytical methods has been elaborated that provides a comprehensive description of the quality of the medicines and later will also be used in quality control and product release). This is all done in parallel to the upscaling and finalization of the formulation, and the manufacturing technology.
Drafting of the patent application
If the development results in an innovation, such as a new pharmaceutical form, particularly advantageous composition or a maunfactuirng process that is valuable from the perspective of industrial property rights, then it is important to obtain the patent protection — in order to increase our competitiveness.
Product manufacturing scale-up
Its aim is to increase the production technology of a medicine created during laboratory experiments to the future commercial production scale. During this multistage process, the parameters affecting quality are determined, the formulation and the manufacturing process are optimized, and the final specifications of the medicine are determined.