Preparation of new radiopharmaceuticals based on monoclonal and recombinant antibodies and peptides labelled by alpha and beta radionuclides
Project goals
A. Choice of approppriate monoclonal antibodies (MABs) and their scFv fragments. The following MABs and their fragments will be examined in the first step: TU-20, an antibody against neuron-specific tubuline, MEM-97, an antibody specific for leukocyte antigen (CD20). B. Development of methods for alpha-radionuclides production and development of methods for labeling the complete MABs or their scFv fragments by selected alpha and/or beta radionuclides. C. Verification of stability of the radiopharmaceuticals obtained and testing of conservation of biological properties of the original MABs. D. A pilot biodistribution study. The above described project will be continued by a preclinical assay of the radipharmaceuticals developed, followed by assuring theproduction of MABs/their fragments and production of final medical products according the GMP concept.
Keywords
monoclonal antibodiesradioactive labeling123-iodine211-astatinebismuth isotepesnuclear medicinescintigraphytargeted therapy
Public support
Provider
Academy of Sciences of the Czech Republic
Programme
Scheme of targeted research and development support
Call for proposals
Program podpory cíleného výzkumu a vývoje 3 (SAV02003-S)
Main participants
ÚJV Řež, a. s.
Ústav jaderné fyziky AV ČR, v. v. i.Contest type
VS - Public tender
Contract ID
—
Alternative language
Project name in Czech
Příprava nových radiofarmak na bázi monoklonálních a rekombinantních protilátek a peptidů značených alfa a beta radionuklidy
Annotation in Czech
A. Výběr vhodných monoklonálních protilátek a jejich seFv fragmentů. Jako první budou systematicky prověřovány tyto MABs a jejich fragmenty: TU-20, protilátka proti neuron specifickému tubulinu; MEM-97, protilátka specifická pro leukocytární antigen (CD20). B. Vypracování metodiky přípravy alfa radionuklidů a vypracování metodik značení celých molekul protilátek i jejich Fv fragmentů vybranými alfa-radionuklidy a beta-radionuklidy. C. Ověření stability připravených radiofarmak a test zachování biologických vlastností použitých protilátek. D. Pilotní studie biodistribuce. Na výše popsaný projekt bude navazovat preklinické ověřování získaných radiofarmak, zajištění podmínek pro výrobu jak monoklonálních protilátek, tak i jejich fragmentů a konečných lékových forem podle požadavků správné výrobní praxe.
Scientific branches
R&D category
NV - Nonindustrial research (Applied research excluded Industrial research)
CEP classification - main branch
CH - Nuclear and quantum chemistry, photo chemistry
CEP - secondary branch
EI - Biotechnology and bionics
CEP - another secondary branch
FD - Oncology and haematology
10402 - Inorganic and nuclear chemistry
20801 - Environmental biotechnology
20802 - Bioremediation, diagnostic biotechnologies (DNA chips and biosensing devices) in environmental management
20803 - Environmental biotechnology related ethics
20901 - Industrial biotechnology
20902 - Bioprocessing technologies (industrial processes relying on biological agents to drive the process) biocatalysis, fermentation
20903 - Bioproducts (products that are manufactured using biological material as feedstock) biomaterials, bioplastics, biofuels, bioderived bulk and fine chemicals, bio-derived novel materials
30204 - Oncology
30205 - Hematology
30401 - Health-related biotechnology
30402 - Technologies involving the manipulation of cells, tissues, organs or the whole organism (assisted reproduction)
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])
30404 - Biomaterials (as related to medical implants, devices, sensors)
30405 - Medical biotechnology related ethics
40401 - Agricultural biotechnology and food biotechnology
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
40403 - Agricultural biotechnology related ethics
Completed project evaluation
Provider evaluation
N - Nesplněno zadání
Project results evaluation
The objective of the project was to examine radiolabeled monoclonal antibody systems with TU-20 and MEM-97. Labeling methods using selected radionuclides and QC methods for labeled antibodies were developed. Pilot biodistribution studies were performed.
Solution timeline
Realization period - beginning
Jan 1, 2003
Realization period - end
Jan 1, 2005
Project status
U - Finished project
Latest support payment
—
Data delivery to CEP
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data delivery code
CEP06-AV0-IB-U/01:1
Data delivery date
Jun 19, 2006
Finance
Total approved costs
7,375 thou. CZK
Public financial support
3,731 thou. CZK
Other public sources
2,842 thou. CZK
Non public and foreign sources
802 thou. CZK
Basic information
Recognised costs
7 375 CZK thou.
Public support
3 731 CZK thou.
50%
Provider
Academy of Sciences of the Czech Republic
CEP
CH - Nuclear and quantum chemistry, photo chemistry
Solution period
01. 01. 2003 - 01. 01. 2005