EU co-financed projects
FENG.01.01-IP.02-0011/24
Bioceltix Joint Stock Company is implementing project no. FENG.01.01-IP.02-0011/24, titled “Construction and commissioning of a pharmaceutical plant for the production of innovative veterinary advanced therapy medicinal products”,
co-financed by the European Funds.
The aim of the project is to implement within Bioceltix S.A. the veterinary advanced therapy medicinal product BCX-CM-J for the treatment of osteoarthritis in dogs, which is the result of completed R&D work. The implementation will be made possible through the establishment and launch of a new pharmaceutical manufacturing facility for innovative veterinary medicinal products.
The project scope includes the implementation module, which covers:
construction works related to adapting the planned leased hall for biological production using cleanroom technology meeting GMP requirements,
purchase and qualification of all equipment necessary for the production of the innovative medicinal product,
commissioning of production.
As a result of the project, the company will begin serial production of the BCX-CM-J product, becoming a pioneer on the Polish and European markets in the field of innovative MSC-based veterinary treatment methods. An important outcome of the project is that the manufacturing facility built in Wrocław will be the largest of its kind in Europe.
The main target groups include dog owners, veterinary clinics, and veterinarians.
Project value: PLN 60,984,030.99
Funding value: PLN 17,353,179.55
#EuropeanFunds
FENG.01.01-IP.02-1615/23
PRACELO 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.
Co-financing agreement No.: POIR.01.01.01-00-0281/16-00
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.
Amount of project co-financing by the EU: PLN 2 712 457,74
Total cost of the project: PLN 4 520 762,90
SZYBKA ŚCIEŻKA 1.1.1.
Bioceltix S.A. is implementing the project entitled:
“Production of allogeneic mesenchymal stem cells isolated from adipose tissue in compliance with Good Manufacturing Practice (GMP) requirements – active substance for an investigational advanced therapy veterinary medicinal product intended for clinical trials in the treatment of osteoarthritis and dysplasia in dogs,”
co-financed by the European Union under the Smart Growth Operational Programme 2014–2020,
Measure 1.1.1: Industrial research and development work carried out by enterprises.
Funding Agreement No.: POIR.01.01.01-00-0281/16-00
Project objective:
The goal of the project is to bring to market an advanced therapy veterinary medicinal product classified as a somatic cell therapy product. The product will be offered in the form of allogeneic (one donor – multiple recipients) mesenchymal stem cells derived from adipose tissue, intended for the treatment of osteoarthritis in dogs.
Project outcome:
The result of the project will be the creation of a certified manufacturing facility for the active substance of advanced therapy veterinary medicinal products based on allogeneic stem cells, produced in accordance with Good Manufacturing Practice (GMP).
This cGMP-standard facility will support the production of the active substance and, together with modern production infrastructure, will enable the development of an innovative investigational veterinary advanced therapy medicinal product based on a novel technology. This ensures the high quality and safety required for the manufacture of active substances, investigational medicinal products, and authorized final medicinal products.
EU co-financing amount: PLN 2,712,457.74
Total project cost: PLN 4,520,762.90
SZYBKA ŚCIEŻKA 1.1.1.
Bioceltix is implementing a project titled:
“Development, Manufacturing, and Clinical Evaluation of a Biological Drug Based on Allogeneic Adipose-Derived Mesenchymal Stromal Cells for the Treatment of Equine Arthritis,”
co-financed by the European Union under Measure 1.1.1 of the Smart Growth Operational Programme 2014–2020.
Grant Agreement Number: POIR.01.01.01-00-0134/19-00
PROJECT OBJECTIVE:
To develop, manufacture in GMP-compliant conditions, and clinically evaluate a new medicinal product based on allogeneic adipose-derived mesenchymal stromal cells for the treatment of degenerative joint disease in horses. The drug’s mechanism of action relies on the immunomodulatory properties of the cells, which serve as the active pharmaceutical ingredient.
PROJECT RESULT:
An innovative veterinary medicinal product containing allogeneic adipose-derived mesenchymal stromal cells as the active ingredient, intended for the treatment of arthritis in working horses. The product will be immediately available and ready for administration directly after thawing.
The compound’s complex, dual-mode mechanism of action represents a significant advantage over conventional anti-inflammatory treatments (NSAIDs and corticosteroids), which offer limited, single-pathway biological effects and carry a considerable risk of adverse side effects.
EU co-financing amount: PLN 5,099,885.23
Total project value: PLN 7,192,495.59
ALFA LEONARTO
PRACELO is implementing the project entitled “New-generation medicinal product for veterinary use, intended for the treatment of atopic dermatitis, wounds and damaged skin”, co-financed by European Union funds within the framework of the Smart Growth Operational Programme 2014-2020, Measure 1.3: R&D activity financed with capital funds participation, Sub-measure 1.3.1: Support for R&D projects at the ‘pre-seed’ stage by proof of concept funds – BRIdge Alfa.
Financial Assistance Agreement No.: 3/Leonarto Alfa/2017 of 13.12.2017
Amount of project co-financing by the EU: PLN 800 000,00
Total cost of the project: PLN 1 000 000,00
ALFA INFINI
PRACELO is implementing a project entailing the marketing of a stem cell-based product for veterinary use, classified as a somatic cell therapy product offered in the form of allogeneic (one donor – many recipients) Adipose Derived Mesenchymal Stem Cells (AD-MSC) from healthy donors, intended for the treatment of degenerative joint diseases and dysplasia in dogs, co-financed by European Union funds within the framework of the Smart Growth Operational Programme 2014-2020, Measure 1.3: R&D activity financed with capital funds participation, Sub-measure 1.3.1: Support for R&D projects at the ‘pre-seed’ stage by proof of concept funds – BRIdge Alfa.
Under the Financial Assistance Agreement concluded in Warsaw on 17 November 2017
Amount of project co-financing by the EU: PLN 800 000,00
Total cost of the project: PLN 1 000 000,00