A module based on the CHO cell and an innovative system for an express biosimilar production platform and the development of the preclinical and clinical development of a biosimilar based on the Fab fragment (Q78867): Difference between revisions
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(Removed 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 project aims to develop an innovative production technology based on a CHO cell and an innovative system for the expression of a biosimilar to ranbizumab...) |
(Created claim: summary (P836): 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). The aim of the project is to develop an innovative production technology based on CHO cells and an innovative system of expression of a biosimila...) |
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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). The aim of the project is to develop an innovative production technology based on CHO cells and an innovative system of expression of a biosimilar drug to ranibizumab used in the treatment of retinal disorders. This process, unlike the market-based referent (produced in the bacterial expression system) will be conducted in the CHO line. The reference market medicine is an antigen binder fragment (Fab) derived from the same starting mouse antibody as the marketable oncology medicine bevacizumab, therefore the applicant established its production using a mammalian expressive system which will significantly affect the cost of manufacturing the product and improve its safety and immunogenicity while maintaining identical biological activity. The project will result in the development and implementation of a biosimilar product used in the treatment of retinal diseases on the market. These diseases are a huge problem of civilisation, which very often affects low-income people. The implementation of the project results will lead to a significant reduction in the price of the latest generation of therapists and their availability, thereby reducing the socio-economic costs associated with these conditions. The project will be implemented for a period of 55 months in 6 stages. The first 5 stages concern industrial research on the development and rescaling of innovative production process, development and validation of analytical methods and confirmation of bioequivalence of the product. The result of these studies will be to obtain and release APIs for clinical trials. The final, 6th stage of the project will be development work, including the preparation of CTA documentation, clinical trials and preparation of the dock (English) | |||||||||||||||
| Property / summary: 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). The aim of the project is to develop an innovative production technology based on CHO cells and an innovative system of expression of a biosimilar drug to ranibizumab used in the treatment of retinal disorders. This process, unlike the market-based referent (produced in the bacterial expression system) will be conducted in the CHO line. The reference market medicine is an antigen binder fragment (Fab) derived from the same starting mouse antibody as the marketable oncology medicine bevacizumab, therefore the applicant established its production using a mammalian expressive system which will significantly affect the cost of manufacturing the product and improve its safety and immunogenicity while maintaining identical biological activity. The project will result in the development and implementation of a biosimilar product used in the treatment of retinal diseases on the market. These diseases are a huge problem of civilisation, which very often affects low-income people. The implementation of the project results will lead to a significant reduction in the price of the latest generation of therapists and their availability, thereby reducing the socio-economic costs associated with these conditions. The project will be implemented for a period of 55 months in 6 stages. The first 5 stages concern industrial research on the development and rescaling of innovative production process, development and validation of analytical methods and confirmation of bioequivalence of the product. The result of these studies will be to obtain and release APIs for clinical trials. The final, 6th stage of the project will be development work, including the preparation of CTA documentation, clinical trials and preparation of the dock (English) / rank | |||||||||||||||
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| Property / summary: 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). The aim of the project is to develop an innovative production technology based on CHO cells and an innovative system of expression of a biosimilar drug to ranibizumab used in the treatment of retinal disorders. This process, unlike the market-based referent (produced in the bacterial expression system) will be conducted in the CHO line. The reference market medicine is an antigen binder fragment (Fab) derived from the same starting mouse antibody as the marketable oncology medicine bevacizumab, therefore the applicant established its production using a mammalian expressive system which will significantly affect the cost of manufacturing the product and improve its safety and immunogenicity while maintaining identical biological activity. The project will result in the development and implementation of a biosimilar product used in the treatment of retinal diseases on the market. These diseases are a huge problem of civilisation, which very often affects low-income people. The implementation of the project results will lead to a significant reduction in the price of the latest generation of therapists and their availability, thereby reducing the socio-economic costs associated with these conditions. The project will be implemented for a period of 55 months in 6 stages. The first 5 stages concern industrial research on the development and rescaling of innovative production process, development and validation of analytical methods and confirmation of bioequivalence of the product. The result of these studies will be to obtain and release APIs for clinical trials. The final, 6th stage of the project will be development work, including the preparation of CTA documentation, clinical trials and preparation of the dock (English) / qualifier | |||||||||||||||
point in time: 14 October 2020
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Revision as of 10:31, 14 October 2020
Project in Poland financed by DG Regio
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | A module based on the CHO cell and an innovative system for an express biosimilar production platform and the development of the preclinical and clinical development of a biosimilar based on the Fab fragment |
Project in Poland financed by DG Regio |
Statements
24,783,037.6 zloty
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38,366,659.2 zloty
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64.6 percent
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1 June 2017
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31 December 2021
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CELON PHARMA S.A.
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52°20'7.8"N, 20°53'42.0"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). Celem projektu jest opracowanie innowacyjnej technologii produkcji w oparciu o komórki CHO i innowacyjny system ekspresji leku biopodobnego do ranibizumab stosowanego w terapii schorzeń siatkówki. Proces ten w odróżnieniu od dostępnego na rynku referenta (produkowanego w bakteryjnym systemie ekspresji) prowadzony będzie w linii CHO. Referencyjny lek rynkowy jest fragmentem przeciwciała wiążącym antygen (Fab) pozyskanym z tego samego wyjściowego mysiego przeciwciała co dostępny na rynku lek onkologiczny bevacizumab, dlatego też wnioskodawca założył jego produkcję przy wykorzystaniu ssaczego systemu ekspresyjnego co wpłynie w znaczący sposób na koszty wytworzenia produktu oraz poprawi jego bezpieczeństwo i immunogenność przy zachowaniu identycznej aktywności biologicznej. Efektem projektu będzie opracowanie oraz wdrożenie na rynek biopodobnego produktu stosowanego w terapii chorób siatkówki. Choroby te stanowią ogromny problem cywilizacyjny który dotyka bardzo często osoby o niskich dochodach. Wdrożenie rezultatów projektu doprowadzi znacznego obniżenia ceny najnowszej generacji terapeutyków oraz zwiększenia ich dostępności a tym samym ograniczenia kosztów społeczno-gospodarczych związanych z tymi schorzeniami. Projekt realizowany będzie przez okres 55 miesięcy w 6 etapach. Pierwsze 5 etapów dotyczy badań przemysłowych nad opracowaniem i przeskalowaniem innowacyjnego procesu produkcji, opracowaniem i walidacją metod analitycznych oraz potwierdzenia biorownoważności produktu. Efektem tych badań będzie uzyskanie i zwolnienie API do badań klinicznych. Ostatnim, 6 etapem projektu, będą prace rozwojowe, obejmujące przygotowaniu dokumentacji CTA, badania kliniczne oraz przygotowanie dok (Polish)
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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). The aim of the project is to develop an innovative production technology based on CHO cells and an innovative system of expression of a biosimilar drug to ranibizumab used in the treatment of retinal disorders. This process, unlike the market-based referent (produced in the bacterial expression system) will be conducted in the CHO line. The reference market medicine is an antigen binder fragment (Fab) derived from the same starting mouse antibody as the marketable oncology medicine bevacizumab, therefore the applicant established its production using a mammalian expressive system which will significantly affect the cost of manufacturing the product and improve its safety and immunogenicity while maintaining identical biological activity. The project will result in the development and implementation of a biosimilar product used in the treatment of retinal diseases on the market. These diseases are a huge problem of civilisation, which very often affects low-income people. The implementation of the project results will lead to a significant reduction in the price of the latest generation of therapists and their availability, thereby reducing the socio-economic costs associated with these conditions. The project will be implemented for a period of 55 months in 6 stages. The first 5 stages concern industrial research on the development and rescaling of innovative production process, development and validation of analytical methods and confirmation of bioequivalence of the product. The result of these studies will be to obtain and release APIs for clinical trials. The final, 6th stage of the project will be development work, including the preparation of CTA documentation, clinical trials and preparation of the dock (English)
14 October 2020
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Identifiers
POIR.01.02.00-00-0010/17
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