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...)
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 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 for retinal therapy.This process, unlike the reference market (produced in a bacterial expression system), will be carried out on the CHO line.The reference market medicine is a fragment of the antibody binding antigen (Fb) derived from the same antibody base as available on the market in the bevacizumab market, and therefore the applicant has set up its production using a mammalian system, which will significantly affect the cost of producing the product and improve its safety and immunogenicity while maintaining an identical biological activity.The project will produce and implement a biosimilar medicinal product used in the treatment of retinal diseases.These diseases represent a huge problem of civilisation, which often affects very often low-income earners.The implementation of the results of the project will lead to a significant reduction in the price of the latest generation of therapeutics and to increase their availability and thus reduce the socio-economic costs associated with these disorders.The project will run for a period of 55 months in 6 steps.The first 5 steps concern industrial research on the development and reclassification of an innovative production process, the development and validation of analytical methods and the confirmation of the availability of the product.The effect of these tests will be to obtain and release the API for clinical investigations.The last, 6 stages of the project will be development activities, including the preparation of the documentation of the CTA, the clinical trials and the preparation of docs. (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 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 for retinal therapy.This process, unlike the reference market (produced in a bacterial expression system), will be carried out on the CHO line.The reference market medicine is a fragment of the antibody binding antigen (Fb) derived from the same antibody base as available on the market in the bevacizumab market, and therefore the applicant has set up its production using a mammalian system, which will significantly affect the cost of producing the product and improve its safety and immunogenicity while maintaining an identical biological activity.The project will produce and implement a biosimilar medicinal product used in the treatment of retinal diseases.These diseases represent a huge problem of civilisation, which often affects very often low-income earners.The implementation of the results of the project will lead to a significant reduction in the price of the latest generation of therapeutics and to increase their availability and thus reduce the socio-economic costs associated with these disorders.The project will run for a period of 55 months in 6 steps.The first 5 steps concern industrial research on the development and reclassification of an innovative production process, the development and validation of analytical methods and the confirmation of the availability of the product.The effect of these tests will be to obtain and release the API for clinical investigations.The last, 6 stages of the project will be development activities, including the preparation of the documentation of the CTA, the clinical trials and the preparation of docs. (English) / rank
Normal rank
 

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

    country
    Poland
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    EU contribution
    24,783,037.6 zloty
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    5,947,929.02 Euro
    exchange rate to Euro
    0.24 Euro
    point in time
    13 January 2020
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    budget
    38,366,659.2 zloty
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    9,207,998.21 Euro
    exchange rate to Euro
    0.24 Euro
    point in time
    13 January 2020
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    co-financing rate
    64.6 percent
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    start time
    1 June 2017
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    end time
    31 December 2021
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    beneficiary name (string)
    CELON PHARMA S.A.
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    beneficiary
    Q2509662
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    coordinate location

    52°20'7.8"N, 20°53'42.0"E
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    summary
    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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    Identifiers

    Polish Kohesio ID
    POIR.01.02.00-00-0010/17
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