We cooperate in the area of the deployment of new advanced therapy medicinal products (ATMPs) both within the framework of joint scientific projects and in the form of commissioned studies.
We propose a comprehensive research & development service for tissue and cell engineering products consisting of:
- development and optimisation of manufacturing conditions,
- validation of the manufacturing process
- obtaining the appropriate consents/authorisations for manufacturing of the product,
- application of the developed product in humans in medicinal experiments
and participation in the:
- design,
- registration,
- and conducting of clinical studies within the framework of Good Manufacturing Practice and Good Clinical Practice with the use of advanced therapy medicinal products.
The service is aimed at people working in academic circles and biomedical companies, who, through their discoveries in the fundamental sciences, are developing potential drugs, and at clinicians and healthcare entities developing new treatment strategies using tissue-engineered products.