TFC-X - characterization, optimization and validation of GMP-grade production of a new biotechnological pharmaceutical product

Provider

Ministry of Industry and Trade

Programme

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Call for proposals

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Main participants

PrimeCell Advanced Therapy, a.s.

Contest type

OP - EU Operational Programme

Contract ID

MPO 76030/17/61600/3590

Project name in Czech

TFC-X - Charakterizace, optimalizace a validace GMP-grade výroby nového biotechnologického léčivého přípravku

Annotation in Czech

Cílem projektu je naplnění následujících výstupů: I. Poloprovoz - vytvoření výrobního řetězce pro přípravu biotechnologického léčivého přípravku TFC-X, kde bude provedeno testování výrobního procesu. II. Ověřená technologie - postup lyofilizace produktu TFC-X pro zachování požadované kvality a aktivity cytokinů

R&D category

VV - Exeperimental development

CEP classification - main branch

EI - Biotechnology and bionics

CEP - secondary branch

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CEP - another secondary branch

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OECD FORD - equivalent branches <br>(according to the <a href="http://www.vyzkum.cz/storage/att/E6EF7938F0E854BAE520AC119FB22E8D/Prevodnik_oboru_Frascati.pdf">converter</a>)

20801 - Environmental biotechnology<br>20802 - Bioremediation, diagnostic biotechnologies (DNA chips and biosensing devices) in environmental management<br>20803 - Environmental biotechnology related ethics<br>20901 - Industrial biotechnology<br>20902 - Bioprocessing technologies (industrial processes relying on biological agents to drive the process) biocatalysis, fermentation<br>20903 - Bioproducts (products that are manufactured using biological material as feedstock) biomaterials, bioplastics, biofuels, bioderived bulk and fine chemicals, bio-derived novel materials<br>30401 - Health-related biotechnology<br>30402 - Technologies involving the manipulation of cells, tissues, organs or the whole organism (assisted reproduction)<br>30403 - Technologies involving identifying the functioning of DNA, proteins and enzymes and how they influence the onset of disease and maintenance of well-being (gene-based diagnostics and therapeutic interventions [pharmacogenomics, gene-based therapeutics])<br>30404 - Biomaterials (as related to medical implants, devices, sensors)<br>30405 - Medical biotechnology related ethics<br>40401 - Agricultural biotechnology and food biotechnology<br>40402 - GM technology (crops and livestock), livestock cloning, marker assisted selection, diagnostics (DNA chips and biosensing devices for the early/accurate detection of diseases) biomass feedstock production technologies, biopharming<br>40403 - Agricultural biotechnology related ethics

Provider evaluation

U - Uspěl podle zadání (s publikovanými či patentovanými výsledky atd.)

Project results evaluation

The main goal of the project was the production of a biotechnological product TFC-X in GMP-grade quality, which can be used in clinical trials. This defined goal of the project was met not only in the form of pilot plant and proven technology, but also in a number of optional outputs. The obtained project outputs in the form of pilot plant and proven technologies follow each other and are in accordance with the development strategy of the beneficiary and also the potential commercialization. Everything goes primarily to the field of human medicine. Through the implementation of the project outputs, it will be possible to obtain the TFC-X product repeatedly and in relatively large quantities, which can be further used for preclinical and clinical safety and efficacy evaluations.

Realization period - beginning

Apr 20, 2017

Realization period - end

Feb 12, 2021

Project status

U - Finished project

Latest support payment

Jun 4, 2018

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Data delivery code

CEP22-MPO-EG-U

Data delivery date

Jun 30, 2022

Total approved costs

13,098 thou. CZK

Public financial support

0 thou. CZK

Other public sources

0 thou. CZK

Non public and foreign sources

4,680 thou. CZK