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C-stemGMP SIGNED

c-GMP compliance of C-stem, an IPSc based cell therapies production technology

Total Cost €

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EC-Contrib. €

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Partnership

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 C-stemGMP project word cloud

Explore the words cloud of the C-stemGMP project. It provides you a very rough idea of what is the project "C-stemGMP" about.

cell    global    encapsulates    device    fda    suffering    pharmaceutical    therapy    therapies    quality    bottleneck    incurable    rare    028    treefrog    replace    boomed    tft    culture    mass    alliance    degenerative    consolidate    2012    failing    underway    time    anticipates    models    cellular    industry    viability    practices    safety    baseline    clients    approve    market    raw    pluripotent    relations    clinical    patients    24    scaling    2025    critical    affordable    financial    provides    secure    scalable    standards    compliant    standard    capture    stem    treatments    healthcare    industrial    position    2bn    supplier    medicine    raquo    materials    stemtm    good    encapsulation    diseases    capacity    2018    killing    outpace    outstanding    pharmas    human    volume    chronic    tissues    material    settings    regenerative    cells    players    manufacturing    months    trials    meet    gene    vision    laquo    gmp    pme    invested    benefits    instrument    big    agencies    regulatory    strategy    therapeutics    multiplication    certified    programs    economic   

Project "C-stemGMP" data sheet

The following table provides information about the project.

Coordinator
TREEFROG THERAPEUTICS 

Organization address
address: 146 RUE LEO SAIGNAR BATIMENT
city: BORDEAUX
postcode: 33000
website: n.a.

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country France [FR]
 Total cost 3˙382˙855 €
 EC max contribution 2˙367˙998 € (70%)
 Programme 1. H2020-EU.3. (PRIORITY 'Societal challenges)
2. H2020-EU.2.3. (INDUSTRIAL LEADERSHIP - Innovation In SMEs)
3. H2020-EU.2.1. (INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies)
 Code Call H2020-SMEInst-2018-2020-2
 Funding Scheme SME-2
 Starting year 2019
 Duration (year-month-day) from 2019-11-01   to  2021-10-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    TREEFROG THERAPEUTICS FR (BORDEAUX) coordinator 2˙367˙998.00

Map

 Project objective

Scaling-up cell therapy manufacturing provides many benefits: the capacity to replace failing tissues in patients suffering from incurable chronic or degenerative diseases, affordable treatments and the economic viability of the development of cell therapies for rare diseases. The baseline of TreeFrog Therapeutics (TFT), “Cell Therapy for All”, encapsulates this vision.TFT has already obtained outstanding results with its C-StemTM stem cell culture technology, fully scalable and allowing a high cell multiplication factor. The cell therapy market has boomed since 2012. In 2018, 1,028 clinical trials were underway according to the Alliance for Regenerative Medicine and big pharmas invested €6.2bn in cell therapy programs. The FDA anticipates to approve « 10 to 20 cell and gene therapy products a year » by 2025. A critical bottleneck remains for the cell therapies that will reach the market within 5 to 10 years: the industrial production of human induced pluripotent stem cells, the raw material for cell therapies. Current manufacturing models do not meet the standards of regulatory authorities and healthcare systems in terms of safety, cost, volume and lead time. With C-StemTM, TFT is in the best position to become the global supplier of stem cells for cell therapy’s industry. Tailored for cost-killing mass-production of stem cells, while defining a new quality standard for cellular products, C-StemTM needs to be certified for “Good Manufacturing Practices” (GMP) to be used in clinical settings and capture its market. This project requires, within 24 months, to develop a GMP encapsulation device, to replace non-compliant materials, while developing relations with EU/US regulatory agencies and clients from the pharmaceutical industry. TFT has a “go-global” strategy and aims at leading its market within 7 years. Funding from the H2020 Instrument PME Phase 2 would secure the project and consolidate TFT on the financial level, a key element to outpace non-european players.

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The information about "C-STEMGMP" are provided by the European Opendata Portal: CORDIS opendata.

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