Lek receives three awards bestowed by the Slovenian Chamber of Commerce and Industry for innovations in the Central Slovenia region

The golden regional award was bestowed for the development of a new generic medicine with tacrolimus in the form of prolonged-release capsules, intended for the treatment of organ transplant patients. The medicine is intended for immunosuppressive treatment of patients with transplanted organs who need life-long treatment with appropriate medicines so that the body does not reject the new organ. The awarded innovation was ranked among the candidates for the national selection of best innovations.

Lek has introduced a number of innovations in the development and production of the tacrolimus medicine: they have introduced a robust work process without exposing operators to the drug substance, developed a new predictive analytical model that accurately predicts the behavior of the medicine in the body, as well as product quality control analytics which is time efficient and requires low solvent consumption. They have also developed a complex composite packaging to ensure the proper quality of the medicine. In addition, they included an innovative strength of the drug in the strength range, which is the first two-milligram tacrolimus prolonged-release capsule on the market. This will enable patients to dose more easily and accurately, which is very important in life-long treatment after organ transplantation. 

“The development and production of generic medicines requires a great deal of innovation, especially in the design and development of new processes and methods. Bringing such a complex medicine to patients is an extremely demanding process, in which, in cooperation with many colleagues from various fields, we have introduced a number of innovations. The entire process, from development to production and packaging of the medicine, takes place in Slovenia. I am proud that in Slovenia we have developed a generic medicine for modern, safe and effective treatment that can improve patients’ quality of life after organ transplantation, and that our innovative approach has also been recognized by the evaluators of innovations at the Chamber of Commerce and Industry,” said Tanja Vilfan, Development Projects Manager at the Development Center Slovenia.

Biologics Technical Development Mengeš received the silver award for a biosensor analytics of biosimilars. Lek as part of Novartis, has been developing and manufacturing biosimilars for many years. Through innovative approaches, they strive to continuously improve the effectiveness of their development. In recent years, they have developed an advanced system of biosensor analytical methods, which, compared to conventional ones, are distinguished by significantly improved time- and cost-efficiency. 

“The introduced system of biosensor analytics method contributed significantly to a more efficient early development of a biosimilars. In this way, we contribute to greater availability of biological medicines and thus to the improvement of peoples’ health and quality of life,” said Jaka Marušič, a senior scientist at Development Analytics at Biologics Technical Development Mengeš.

The Chamber of Commerce and Industry for the Central Slovenian region bestowed the bronze award to the project Modeling and Simulation of the Lyophilization Process for Biological Drug Substances. The project enables introduction of next level of quality by design approach in lyophilization process development, which is based on an in-depth process understanding and the reduction of costs and errors with technology process scale-up. The new approach replaces most of the experimental work, which requires high drug substance and time consumption, with computer simulations which calculates optimal process design space. The project was developed by Biologics Technical Development Mengeš, in cooperation with the Faculty of Mechanical Engineering of the University of Maribor and the Faculty of Mechanical Engineering of the University of Ljubljana 

The awarded team emphasized: “At the department of laboratory development of formulations, where we have been developing this innovation, we are very pleased and happy that the project received the bronze regional award for innovation 2020 by Slovenian the Chamber of Commerce. This recognition proves the success of the innovation culture in the company for which all employees strive and which inspires us for further innovative work and confirms the importance of cooperation between the pharmaceutical industry and academia. We will continue to strive for further innovative projects in cooperation with academia, the result of which could be another successful and rewarding project.”