Human GAMMA- GLUTAMYLTRANSFERASE (GGT) buffer solution in vials

This document outlines a planned procurement opportunity by the European Commission's Joint Research Centre (DG JRC) for the supply of human gamma-glutamyltransferase (GGT) buffer solution in vials. This tender, identified by the call identifier EC-JRC/GEE/2025/LVP/6694-EXA, is specifically aimed at obtaining 4,000 vials, each containing 1 ml of lyophilized buffer solution with human GGT at approximately 120 U/L. The principal goal is to produce certified reference materials essential for the standardization of clinical biomarker measurements across the EU.

The manufacturing duration for this contract is eight months. The contract is classified as a supply contract and is not suitable for small and medium-sized enterprises, indicating that it may require larger production capabilities or specialized infrastructure. The procurement will utilize an electronic submission process. Interested parties can submit questions during the tendering period. The publication date for this opportunity is December 8, 2025, with a registration deadline set for December 22, 2025, at 23:59:59 UTC+1.

Eligible applicants are expected manufacturers with established expertise in producing enzyme reference materials. The formulation will require the successful manufacturer to provide evidence of previous production of similar materials and demonstrate assessments of stability and precision in filling processes.

The tender focuses significantly on technical capabilities within the biotech and medical technology sectors, particularly for organizations capable of meeting the requirements for clinical diagnostics and reference materials. Although the specific funding amount is not disclosed, it has been classified as a middle/low value procurement. This opportunity emphasizes the necessity for accurate, high-quality material production for the enhancement of diagnostic consistency across healthcare systems in the member states of the EU.

There are no explicit co-funding requirements associated with this procurement, as it is structured as a direct purchase contract. The entire procurement process operates under standard EU regulations, typically open to EU member states and potential international suppliers complying with the technical specifications.

The procurement thus represents a critical investment in advancing the standardization of clinical measurements, aiming to improve the reliability and comparability of diagnostic tests across Europe.

This is a publication announcing the contracting authority’s intention to publish a future negotiated low or middle value procedure, not a call for tenders. The procedure identifier is EC-JRC/GEE/2025/LVP/6694-EXA. The JRC-Geel Reference Materials Unit develops reference materials (RM) to support the standardisation of clinical biomarkers measurements in the EU. To support the standardisation of enzyme measurements, a candidate RM is needed to produce a new certified reference material for gamma-glutamyltransferase (GGT). This candidate RM should be supplied in a batch of 4000 vials. Each vial should contain, in lyophilised form, 1 ml of buffer solution with human GGT at a catalytic activity concentration around 120 U/L. The manufacturer should provide evidence of the successful production of similar enzyme materials. This evidence should include data on the stability of the materials and the precision of the filling of vials. The procedure type is a planned negotiated procedure for middle/low value contract. The lead contracting authority is the European Commission, DG JRC - Joint Research Centre. The main classification (CPV) code is 24965000 - Enzymes. The nature of the contract is supplies. The maximum contract duration is 8 months. There is no framework agreement. The start date for expression of interest is 2025-12-08 Europe/Brussels. The deadline for expression of interest is 23/12/2025 06:59 Europe/Brussels. The indicative date of launch of the negotiated procedure is 2025-12-23 Europe/Brussels. The method of expression of interest is electronic. Submissions must be sent exclusively at the address for submission given.

A question was asked: Where can I find the procurement documents for calls for tenders with ‘ExA' in the reference? The answer provided was: References that feature an ‘ExA’ are not calls for tenders. They are a publication announcing the contracting authority’s intent to launch in the future a low or middle negotiated procedure. This was published on 03/10/2024 17:32.

In summary, the European Commission's Joint Research Centre (JRC) in Geel is planning a negotiated procurement procedure to acquire a candidate reference material for gamma-glutamyltransferase (GGT), an enzyme used in clinical biomarker measurements. This is not a tender yet, but a pre-announcement. The JRC requires a batch of 4000 vials, each containing a lyophilized buffer solution with human GGT at a specific concentration. The selected manufacturer must demonstrate experience in producing similar enzyme materials, including data on stability and filling precision. The contract is expected to last for a maximum of 8 months. Companies interested in participating in the future negotiated procedure should express their interest electronically between December 8th and December 23rd, 2025. The actual launch of the negotiated procedure is indicatively scheduled for December 23rd, 2025. This procurement aims to support the standardization of enzyme measurements within the EU.

Eligible Applicant Types: The opportunity is open to manufacturers capable of producing similar enzyme materials. The manufacturer should provide evidence of the successful production of similar enzyme materials.

Funding Type: Procurement. This is a planned negotiated procedure for a middle/low value contract, specifically for supplies.

Consortium Requirement: The information suggests a single applicant is required, as the focus is on a manufacturer providing the specified materials.

Beneficiary Scope (Geographic Eligibility): The JRC-Geel Reference Materials Unit develops reference materials (RM) to support the standardisation of clinical biomarkers measurements in the EU, which suggests that the geographic eligibility is within the EU.

Target Sector: Biotech/Medtech, Pharma/Healthcare. The call is specifically for a human GAMMA-GLUTAMYLTRANSFERASE (GGT) buffer solution, which falls under clinical biomarker measurements.

Mentioned Countries: No specific countries are mentioned, but the context implies the European Union (EU) due to the mention of the JRC's role in standardizing clinical biomarker measurements in the EU.

Project Stage: The project is at the production stage, requiring a manufacturer to supply a candidate reference material.

Funding Amount: The opportunity is described as a "middle/low value contract," but the exact amount is not specified.

Application Type: Planned negotiated procedure. An expression of interest is required initially, followed by a negotiated procedure.

Nature of Support: Money. The selected manufacturer will receive payment for the supply of the required materials.

Application Stages: The application process appears to have at least two stages: an expression of interest and a subsequent negotiated procedure.

Success Rates: Success rates are not mentioned in the provided text.

Co-funding Requirement: Co-funding requirements are not mentioned in the provided text.

Summary:

This is a pre-announcement for a future negotiated procurement procedure by the European Commission, DG JRC - Joint Research Centre, specifically the JRC-Geel Reference Materials Unit. The JRC is seeking a manufacturer to supply a candidate reference material for gamma-glutamyltransferase (GGT). This material will be used to produce a new certified reference material for GGT to support the standardization of enzyme measurements in the EU. The selected manufacturer will need to provide 4000 vials, each containing 1 ml of lyophilised buffer solution with human GGT at a catalytic activity concentration around 120 U/L. The manufacturer must demonstrate experience in producing similar enzyme materials, including data on material stability and vial filling precision. The procedure is classified as a middle/low value contract, and the maximum contract duration is 8 months. The start date for expressing interest is planned for December 8, 2025, with a deadline of December 23, 2025. The indicative date for launching the negotiated procedure is December 23, 2025. Interested parties must submit an electronic expression of interest. This is not a call for tenders but an announcement of the contracting authority’s intention to publish a future negotiated procedure.