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Custom-made GMP peptides

Radboud universitair medisch centrum · 1 lots · 368193
Type
Supplies
33600000
Estimated value
Not published
To deadline
Ongoing
Knock-outs
n/a
exclusion grounds
Award basis
Best price-quality ratio
Assess manuallyconfidence low

The tender concerns the supply of custom-made GMP peptides in API quality, required for the PROTECT-lynch study into a preventive dendritic cell therapy for LS patients. The contracting authority, Radboud Universitair Medisch Centrum, has a KWF grant, is located in the Netherlands (NL226) and requires a supplier with a GMP API certificate, a European manufacturing facility and the capability to perform established stability studies according to ICH guidelines.

Supplies · European procedure

European
Contracting authority
Radboud universitair medisch centrum
Contract type
Supplies
Estimated value
Estimate not published
Submission deadline
Ongoing
Scope
European
European procedure
Lots
1
1 lots
Main CPV code
33600000
Location
Netherlands
CharacteristicsCPV 33SuppliesEU tender

01What is being requested

The tender concerns the supply of custom-made GMP peptides in API quality, required for the PROTECT-lynch study into a preventive dendritic cell therapy for LS patients. The contracting authority, Radboud Universitair Medisch Centrum, has a KWF grant, is located in the Netherlands (NL226) and requires a supplier with a GMP API certificate, a European manufacturing facility and the capability to perform established stability studies according to ICH guidelines.

The Department of Medical BioSciences from Radboudumc has been award 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 t

33600000Supplies
1Custom-made GMP peptides€1

02Exclusion grounds

Exclusion grounds — consult the ESPD
  • No specific exclusion grounds were extracted. In a European tender, the mandatory and discretionary grounds of art. 2.86/2.87 of the Dutch Procurement Act almost always apply — check the European Single Procurement Document (ESPD).

03Value in context

Estimate not published

The contracting authority did not publish an estimated value — common for a large share of contracts. The EU threshold for leveringen is € 221.000, for reference.

04Likely competitors

#Likely bidderFitWins
1Medtronic Trading NL B.V.SME8230×
2Boston Scientific Nederland B.V.SME7720×
3Johnson & Johnson Medical B.V.SME7016×
4Abbott Medical Nederland B.V.SME7016×
5Skills Meducation B.V.SME6410×
6GlaxoSmithKline B.V.SME636×

05Frequently asked questions

What is the specific nature of the requested supplies?
The assignment concerns the supply of custom-made GMP peptides in API quality (drug substance). These peptides are necessary for the PROTECT-lynch study into a preventive dendritic cell therapy for LS patients.
What certification and production location must the supplier comply with?
The manufacturer must possess a GMP API manufacturing certificate and the production facility must be located in Europe.
What additional requirements are imposed on the execution of the assignment?
The supplier must be able to provide the execution of stability studies per peptide according to the ICH guidelines and be able to adhere to strict timelines.
What is the purpose of the peptides within the PROTECT-lynch study?
The peptides are used to support the effectiveness of the intended dendritic cell therapy, in which tumor-specific peptides (neoantigens) are deployed for the development of a new treatment for LS patients.

Automatically compiled from the official tender data and documents.

06Estimated value versus the market

p25
€ 317K
median
€ 892K
p75
€ 3,3 mln
deze opdracht

Gegunde waarden in CPV 33 · leveringen n=528