Nyderlandai – Laboratoriniai reagentai – Custom-made mRNA (GMP)
Nyderlandai – Laboratoriniai reagentai – Custom-made mRNA (GMP)
I dalis: Perkančioji organizacija
I.1) Pavadinimas ir adresai:
Oficialus
pavadinimas: Radboud Universitair Medisch Centrum/Radboudumc
Adresas: Geert Grooteplein Zuid 10
Miestas: Nijmegen
Pašto
kodas: 6525GA
Šalis: Nyderlandai
Asmuo
ryšiams:
El-paštas: willem.busser@radboudumc.nl
Interneto adresas (-ai):
II dalis: Objektas
II.1.1) Pavadinimas:
Custom-made mRNA (GMP)
II.1.2) Pagrindinis BVPŽ kodas:
33696500
Laboratoriniai reagentai
II.1.3) Sutarties tipas:
Kita
II.1.4) Trumpas aprašymas:
The Department of Medical BioSciences from Radboudumc has been awarded a KWF grant for the PROTECT-lynch study. The main goal of the PROTECT-lynch study is a new treatment option for LS patients significantly improving the quality of life of LS patients and most likely the prognosis (occurrence of Lynch-related cancer(s). Standard care for healthy LS patients currently consists of undergoing intensive surveillance programs that do not guarantee timely detection of one or more Lynch-related cancers at a treatable stage. The PROTECT-lynch study may change this with its preventive dendritic cell therapy. To prepare the intended dendritic cell (DC) product for the PROTECT-lynch study, mRNA coding for carcino-embryonic antigen (CEA) is required in GMP quality. As the Medical BioSciences department, we have extensive experience in the preparation of DC products in collaboration with the Pharmacy department, in which comparable mRNA was used as raw material for the DC product. The mRNA will form a complex with protamine, which will be added as stimulant to the DC product to fully mature the DCs. For this extensive project the Medical BioSciences department is looking for a reliable supplier of custom-made mRNA in GMP quality in the requested quantities. Depending on the stability of the mRNA, execution of stability studies of the mRNA according to ICH guidelines and strict timelines may be needed. This manufacturer must hold a GMP manufacturing certificate and have their production facility in Europe. The custom-made GMP mRNA that will be used in the PROTECT-lynch study (phase I/II) is expected to be utilized in a large-scale follow-up study (phase III). It is crucial for us that the supplier, who is going to accept the assignment of the custom-made GMP mRNA, is reliable (able to meet agreed timelines and fulfill the assignment).
II.2) Aprašymas:
II.2.1) Kitas (-i) šio pirkimo BVPŽ kodas (-ai):
33696500 Laboratoriniai reagentai