Custom-made mRNA (GMP)

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). …

CPV: 33696500 Laboratooriumireaktiivid, 33696000 Reaktiivid ja kontrastvahendid
Täitmise koht:
Custom-made mRNA (GMP)
Auhindade andmise asutus:
Radboud Universitair Medisch Centrum/Radboudumc
Auhinna number:

1. Buyer

1.1 Buyer

Official name : Radboud Universitair Medisch Centrum/Radboudumc
Legal type of the buyer : Public undertaking
Activity of the contracting authority : Health

2. Procedure

2.1 Procedure

Title : Custom-made mRNA (GMP)
Description : 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).

2.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33696500 Laboratory reagents
Additional classification ( cpv ): 33696000 Reagents and contrast media

2.1.2 Place of performance

Country : Netherlands
Anywhere in the given country
Additional information : Zie documentatie

2.1.3 Value

Estimated value excluding VAT : 1 Euro

2.1.4 General information

Additional information : Zie aanbestedingsdocumenten zoals opgenomen Source-to-Contract (Mercell) en/of neem contact op de betrokken inkoopadviseur.
Legal basis :
Directive 2014/24/EU

3. Part

3.1 Part technical ID : PAR-0000

Title : Custom-made mRNA (GMP)
Description : 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).

3.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33696500 Laboratory reagents
Additional classification ( cpv ): 33696000 Reagents and contrast media

3.1.2 Place of performance

Country : Netherlands
Anywhere in the given country
Additional information : Zie documentatie

3.1.4 Value

Estimated value excluding VAT : 1 Euro

3.1.5 General information

The procurement is covered by the Government Procurement Agreement (GPA) : yes
Additional information : Zie aanbestedingsdocumenten zoals opgenomen Source-to-Contract (Mercell) en/of neem contact op de betrokken inkoopadviseur.

3.1.6 Procurement documents

Address of the procurement documents : https://s2c.mercell.com/today/145898 ,

3.1.9 Further information, mediation and review

Review organisation : Rechtbank Gelderland -
Organisation providing more information on the review procedures : Radboud Universitair Medisch Centrum/Radboudumc -

8. Organisations

8.1 ORG-0001

Official name : Radboud Universitair Medisch Centrum/Radboudumc
Registration number : 80262783
Postal address : Geert Grooteplein Zuid 10
Town : Nijmegen
Postcode : 6525GA
Country subdivision (NUTS) : Arnhem/Nijmegen ( NL226 )
Country : Netherlands
Contact point : Willem Busser
Telephone : +31650004492
Roles of this organisation :
Buyer
Organisation providing more information on the review procedures

8.1 ORG-0002

Official name : Rechtbank Gelderland
Registration number : 82940827
Postal address : Walburgstraat 2-4
Town : Arnhem
Postcode : 6811CD
Country subdivision (NUTS) : Arnhem/Nijmegen ( NL226 )
Country : Netherlands
Contact point : Radboudumc
Telephone : +31650004492
Internet address : https://www.radboudumc.nl
Information exchange endpoint (URL) : https://www.radboudumc.nl
Roles of this organisation :
Review organisation
Notice information
Notice identifier/version : d93acaa5-fadb-4d3d-a420-0967f085488a - 01
Form type : Planning
Notice type : Prior information notice or a periodic indicative notice used only for information
Notice dispatch date : 09/04/2025 19:57 +00:00
Notice dispatch date (eSender) : 09/04/2025 19:59 +00:00
Languages in which this notice is officially available : English
Notice publication number : 00236986-2025
OJ S issue number : 72/2025
Publication date : 11/04/2025
Estimated date of publication of a contract notice within this procedure : 13/06/2025