The production of allogeneic stem cells isolated from fatty tissue in accordance with the requirements of Good Manufacturing Practice — active substance for the investigational veterinary medicinal product for clinical trials for the treatment of osteoarthritis and disinfestation in dogs. (Q77859): Difference between revisions
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(Created claim: summary (P836): Reference_reference_programme_aids:SA.41471 (2015/X) _public:Article 25 of Commission Regulation (EC) No 651/2014 of 17 June 2014 declaring certain categories of aid compatible with the internal market in the application of Article 107 and 108 of the Treaty (OJ(OJ LEU L 187/1, 26.06.2014).The aim of this project is to meet the meniscous stem cells produced in optimised real-life operating conditions provided by modern production facilities meeti...) |
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Reference_reference_programme_aids:SA.41471 (2015/X) _public:Article 25 of Commission Regulation (EC) No 651/2014 of 17 June 2014 declaring certain categories of aid compatible with the internal market in the application of Article 107 and 108 of the Treaty (OJ(OJ LEU L 187/1, 26.06.2014).The aim of this project is to meet the meniscous stem cells produced in optimised real-life operating conditions provided by modern production facilities meeting the requirements of Good Manufacturing Practice.The cells at first will allow optimisation of the production process and quality control, on the basis of which product batches will be manufactured for both the validation of the production process, the certification of compliance with the requirements of Good Manufacturing Practice and the subsequent production of an innovation in Europe of a veterinary medicinal product for advanced therapy for clinical trials in the treatment of osteoarthritis and disinfestation in dogs developed by the Applicant.The product will be based on the homogenate of the allogeneic population of the mezenymous stem cells isolated from the fatty tissue of suitably classified donor dog.The innovative character of the product to be presented will be reflected in the quality and safety of the mezenymous stem cells of the active substance.This quality will be achieved by the characterisation of cells obtained after breeding for both morphological, phenotypic, genetic and functional cultures. (English) | |||
| Property / summary: Reference_reference_programme_aids:SA.41471 (2015/X) _public:Article 25 of Commission Regulation (EC) No 651/2014 of 17 June 2014 declaring certain categories of aid compatible with the internal market in the application of Article 107 and 108 of the Treaty (OJ(OJ LEU L 187/1, 26.06.2014).The aim of this project is to meet the meniscous stem cells produced in optimised real-life operating conditions provided by modern production facilities meeting the requirements of Good Manufacturing Practice.The cells at first will allow optimisation of the production process and quality control, on the basis of which product batches will be manufactured for both the validation of the production process, the certification of compliance with the requirements of Good Manufacturing Practice and the subsequent production of an innovation in Europe of a veterinary medicinal product for advanced therapy for clinical trials in the treatment of osteoarthritis and disinfestation in dogs developed by the Applicant.The product will be based on the homogenate of the allogeneic population of the mezenymous stem cells isolated from the fatty tissue of suitably classified donor dog.The innovative character of the product to be presented will be reflected in the quality and safety of the mezenymous stem cells of the active substance.This quality will be achieved by the characterisation of cells obtained after breeding for both morphological, phenotypic, genetic and functional cultures. (English) / rank | |||
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Revision as of 08:58, 4 March 2020
Project in Poland financed by DG Regio
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | The production of allogeneic stem cells isolated from fatty tissue in accordance with the requirements of Good Manufacturing Practice — active substance for the investigational veterinary medicinal product for clinical trials for the treatment of osteoarthritis and disinfestation in dogs. |
Project in Poland financed by DG Regio |
Statements
2,710,971.5 zloty
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4,518,285.83 zloty
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60.0 percent
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1 February 2017
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29 February 2020
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BIOCELTIX SPÓŁKA AKCYJNA
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51°7'34.7"N, 16°58'41.5"E
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Numer_referencyjny_programu_pomocowego: SA.41471(2015/X) Przeznaczenie_pomocy_publicznej: art. 25 rozporządzenia KE nr 651/2014 z dnia 17 czerwca 2014 r. uznające niektóre rodzaje pomocy za zgodne z rynkiem wewnętrznym w stosowaniu art. 107 i 108 Traktatu (Dz. Urz. UE L 187/1 z 26.06.2014). Przedmiotem niniejszego projektu są mezenchymalne komórki macierzyste wytworzone w zoptymalizowanych warunkach rzeczywistego funkcjonowania zapewnionych poprzez zastosowanie nowoczesnego zaplecza produkcyjnego spełniającego wymagania Dobrej Praktyki Wytwarzania. Początkowo przedmiotowe komórki pozwolą na optymalizację procesu produkcji jak i Kontroli Jakości, na bazie których zostaną wytworzone serie pilotażowe produktu przeznaczone zarówno do walidacji procesu produkcji, certyfikacji zgodności z wymaganiami Dobrej Praktyki Wytwarzania oraz do późniejszej produkcji innowacyjnego w skali Europy weterynaryjnego produktu leczniczego terapii zaawansowanej przeznaczonego do badań klinicznych w leczeniu zmian zwyrodnieniowych stawów i dysplazji u psów opracowanego przez Wnioskodawcę. Produkt będzie bazował na homogennej populacji allogenicznych mezenchymalnych komórek macierzystych izolowanych z tkanki tłuszczowej odpowiednio sklasyfikowanego psiego dawcy. Innowacyjny charakter przedstawianego produktu będzie przejawiał się w jakości i bezpieczeństwie mezenchymalnych komórek macierzystych stanowiących substancje czynną produktu. Wspomniana jakość będzie możliwa do osiągnięcia poprzez scharakteryzowanie komórek uzyskanych po hodowli zarówno pod kątem morfologicznym, fenotypowym, genetycznym jak i funkcjonalnym. (Polish)
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Reference_reference_programme_aids:SA.41471 (2015/X) _public:Article 25 of Commission Regulation (EC) No 651/2014 of 17 June 2014 declaring certain categories of aid compatible with the internal market in the application of Article 107 and 108 of the Treaty (OJ(OJ LEU L 187/1, 26.06.2014).The aim of this project is to meet the meniscous stem cells produced in optimised real-life operating conditions provided by modern production facilities meeting the requirements of Good Manufacturing Practice.The cells at first will allow optimisation of the production process and quality control, on the basis of which product batches will be manufactured for both the validation of the production process, the certification of compliance with the requirements of Good Manufacturing Practice and the subsequent production of an innovation in Europe of a veterinary medicinal product for advanced therapy for clinical trials in the treatment of osteoarthritis and disinfestation in dogs developed by the Applicant.The product will be based on the homogenate of the allogeneic population of the mezenymous stem cells isolated from the fatty tissue of suitably classified donor dog.The innovative character of the product to be presented will be reflected in the quality and safety of the mezenymous stem cells of the active substance.This quality will be achieved by the characterisation of cells obtained after breeding for both morphological, phenotypic, genetic and functional cultures. (English)
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Identifiers
POIR.01.01.01-00-0281/16
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