Development of an innovative technology for the therapeutic use of therapeutic antibodies on the basis of bacterial expression systems integrating fixed-less steel and Single-use technology (Q78203): Difference between revisions
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(Removed claim: summary (P836): The objective of R & D is to develop a global innovative technology for the production of a fragment of the monoclonal antibody produced in the E.coli cells by using recombinant DNA technology.The project assumes the work of an innovative technology for the production of an MAB fragment based on bacterial express systems.The implementation of the results will allow for the launch of a high-efficient production of own tested protein fragments....) |
(Created claim: summary (P836): The aim of the R & D project is to develop a globally innovative technology to produce a fragment of the monoclonal antibody produced in E.coli cells using recombinant DNA technology. The project assumes the implementation of works based on innovative technology for the production of Mabs fragment based on bacterial expressive systems. Implementation of the results will allow the launch of highly efficient own production of the analysed protein...) |
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The aim of the R & D project is to develop a globally innovative technology to produce a fragment of the monoclonal antibody produced in E.coli cells using recombinant DNA technology. The project assumes the implementation of works based on innovative technology for the production of Mabs fragment based on bacterial expressive systems. Implementation of the results will allow the launch of highly efficient own production of the analysed protein fragment.The scope of development works involves carrying out research aimed at increasing the scale of the new process to a full production scale meeting GMP standards, while at the same time developing analytical and biological methods. The planned global process innovation is the integration of traditional downstream and upstream technology „stainless steel” with modern solutions „single-use, which has not yet been used in the production of a reference substance. Innovation fits into the scope of the National Intelligent Specialisations and will increase flexibility and cost-effectiveness, production compared to the reference medicine, while maintaining high safety of the medicine and will be a novelty in the world.The project is a response to a significant global problem of increasing number of diseases on macular damage (AMD, DME, RVO). Reference number of the aid programme: SA.41471(2015/X) Purpose of public aid: Article 25 of EC Regulation No 651/2014 of 17 June 2014 declaring certain types of aid compatible with the internal market in the application of Articles 107 and 108 of the Treaty (OJ L. I'm sorry. EU L 187/1 of 26.06.2014). (English) | |||||||||||||||
| Property / summary: The aim of the R & D project is to develop a globally innovative technology to produce a fragment of the monoclonal antibody produced in E.coli cells using recombinant DNA technology. The project assumes the implementation of works based on innovative technology for the production of Mabs fragment based on bacterial expressive systems. Implementation of the results will allow the launch of highly efficient own production of the analysed protein fragment.The scope of development works involves carrying out research aimed at increasing the scale of the new process to a full production scale meeting GMP standards, while at the same time developing analytical and biological methods. The planned global process innovation is the integration of traditional downstream and upstream technology „stainless steel” with modern solutions „single-use, which has not yet been used in the production of a reference substance. Innovation fits into the scope of the National Intelligent Specialisations and will increase flexibility and cost-effectiveness, production compared to the reference medicine, while maintaining high safety of the medicine and will be a novelty in the world.The project is a response to a significant global problem of increasing number of diseases on macular damage (AMD, DME, RVO). Reference number of the aid programme: SA.41471(2015/X) Purpose of public aid: Article 25 of EC Regulation No 651/2014 of 17 June 2014 declaring certain types of aid compatible with the internal market in the application of Articles 107 and 108 of the Treaty (OJ L. I'm sorry. EU L 187/1 of 26.06.2014). (English) / rank | |||||||||||||||
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| Property / summary: The aim of the R & D project is to develop a globally innovative technology to produce a fragment of the monoclonal antibody produced in E.coli cells using recombinant DNA technology. The project assumes the implementation of works based on innovative technology for the production of Mabs fragment based on bacterial expressive systems. Implementation of the results will allow the launch of highly efficient own production of the analysed protein fragment.The scope of development works involves carrying out research aimed at increasing the scale of the new process to a full production scale meeting GMP standards, while at the same time developing analytical and biological methods. The planned global process innovation is the integration of traditional downstream and upstream technology „stainless steel” with modern solutions „single-use, which has not yet been used in the production of a reference substance. Innovation fits into the scope of the National Intelligent Specialisations and will increase flexibility and cost-effectiveness, production compared to the reference medicine, while maintaining high safety of the medicine and will be a novelty in the world.The project is a response to a significant global problem of increasing number of diseases on macular damage (AMD, DME, RVO). Reference number of the aid programme: SA.41471(2015/X) Purpose of public aid: Article 25 of EC Regulation No 651/2014 of 17 June 2014 declaring certain types of aid compatible with the internal market in the application of Articles 107 and 108 of the Treaty (OJ L. I'm sorry. EU L 187/1 of 26.06.2014). (English) / qualifier | |||||||||||||||
point in time: 14 October 2020
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Revision as of 11:38, 14 October 2020
Project in Poland financed by DG Regio
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | Development of an innovative technology for the therapeutic use of therapeutic antibodies on the basis of bacterial expression systems integrating fixed-less steel and Single-use technology |
Project in Poland financed by DG Regio |
Statements
6,785,029.97 zloty
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16,962,574.96 zloty
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40.0 percent
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1 January 2017
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30 June 2020
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POLPHARMA BIOLOGICS SPÓŁKA AKCYJNA
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54°14'44.2"N, 18°6'35.6"E
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Celem przedsięwzięcia B+R jest opracowanie innowacyjnej na skalę światową technologii do produkcji fragmentu przeciwciała monoklonalnego wytwarzanego w komórkach E.coli za pomocą technologii rekombinacji DNA. W Projekcie założono realizację prac opartych na innowacyjnej technologii do produkcji fragmentu mAbs w oparciu o bakteryjne systemy ekspresyjne. Wdrożenie wyników pozwoli na uruchomienie wysokoefektywnej produkcji własnej badanego fragmentu białka.Zakres prac rozwojowych zakłada przeprowadzenie prac badawczych mających na celu zwiększanie skali nowego procesu do pełnej skali produkcyjnej spełniającej standardy GMP, przy jednoczesnym rozwoju metod analitycznych i biologicznych. Planowana do wdrożenia innowacja procesowa w skali światowej to integracja tradycyjnie wykorzystywanej w procesie downstream i upstream technologii „stainless steel” z nowoczesnymi rozwiązaniami „single-use”, która dotąd nie była stosowana w procesie produkcji substancji referencyjnej. Innowacja wpisuje się w zakres Krajowych Inteligentnych Specjalizacji i wpłynie na wzrost elastyczności i efektywności kosztowej, produkcji w stosunku do leku referencyjnego, przy jednoczesnym zachowaniu wysokiej bezpieczeństwa leku i będzie stanowić nowość w skali świata.Projekt stanowi odpowiedź na istotny w skali globalnej problem rosnącej lb. zachorowań na uszkodzenia plamki żółtej oka (AMD, DME, RVO) spowodowany m.in. zmianami społeczno-demograficznymi związanymi ze starzeniem się społeczeństwa.Realizacja Projektu ukierunkowana jest na opracowanie założeń pierwszej na świecie tego typu technologii w skali przemysłowej dla badanego w Projekcie fragmentu przeciwciała. 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). (Polish)
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The aim of the R & D project is to develop a globally innovative technology to produce a fragment of the monoclonal antibody produced in E.coli cells using recombinant DNA technology. The project assumes the implementation of works based on innovative technology for the production of Mabs fragment based on bacterial expressive systems. Implementation of the results will allow the launch of highly efficient own production of the analysed protein fragment.The scope of development works involves carrying out research aimed at increasing the scale of the new process to a full production scale meeting GMP standards, while at the same time developing analytical and biological methods. The planned global process innovation is the integration of traditional downstream and upstream technology „stainless steel” with modern solutions „single-use, which has not yet been used in the production of a reference substance. Innovation fits into the scope of the National Intelligent Specialisations and will increase flexibility and cost-effectiveness, production compared to the reference medicine, while maintaining high safety of the medicine and will be a novelty in the world.The project is a response to a significant global problem of increasing number of diseases on macular damage (AMD, DME, RVO). Reference number of the aid programme: SA.41471(2015/X) Purpose of public aid: Article 25 of EC Regulation No 651/2014 of 17 June 2014 declaring certain types of aid compatible with the internal market in the application of Articles 107 and 108 of the Treaty (OJ L. I'm sorry. EU L 187/1 of 26.06.2014). (English)
14 October 2020
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Identifiers
POIR.01.01.01-00-0650/16
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