Bioceltix is implementing the project entitled “The production of adipose tissue-derived allogeneic mesenchymal stem cells as compliant with the requirements of Good Manufacturing Practice – an active substance for the investigational medicinal product for advanced-therapy veterinary use, intended for clinical trials in the treatment of degenerative changes of joints and dysplasia in dogs”, co-financed by European Union funds within the framework of the Smart Growth Operational Programme 2014-2020, Measure 1.1.1. R&D projects aimed at commercialisation and marketing a particular solution are eligible for “fast track” co-financing.
THE SUBJECT OF THE PROJECT are mesenchymal stem cells produced under optimised field conditions of modern production facilities compliant with the requirements of Good Manufacturing Practice. This will initially optimise the production process as well as Quality Control.
THE OBJECTIVE OF THE PROJECT is to market an advanced-therapy medicinal product for veterinary use classified as a somatic cell therapy product offered in the form of allogeneic (one donor – many recipients) adipose tissue-derived mesenchymal stem cells, intended for use in treating degenerative joint diseases in dogs.
THE RESULT OF THE PROJECT will be the creation of a certified facility for producing active pharmaceutical ingredients of advanced-therapy medicinal products for veterinary use based on allogeneic stem cells produced in accordance with the requirements of Good Manufacturing Practice. The cGMP-compliant facility will be used to produce the active pharmaceutical ingredient, which in tandem with state-of-the-art production equipment will enable the creation of an innovative, advanced-therapy medicinal product using a completely novel technology. The technology will provide the high level of quality and safety required for the production of the active pharmaceutical ingredients, the investigational medicinal products, and the finished medicinal products authorised for marketing.
THE PRODUCT will be based on a homogeneous population of allogeneic mesenchymal stem cells isolated from the adipose tissue of an eligible (screened) canine donor. The innovative characteristics of the product will be the quality and safety of the mesenchymal stem cells used as its active pharmaceutical ingredient.