In vitro intrinsic hepatic clearance and plasma protein binding studies for protocol optimisation

Open invitation to tender by the European Commission Joint Research Centre (JRC) for laboratory services to perform in vitro intrinsic hepatic clearance and plasma protein binding (PPB) assays on a defined set of chemicals following mandatory JRC Standard Operating Procedures (SOPs). The contractor must generate harmonised, high-quality experimental data and provide a critical assessment of their SOP implementation. Estimated contract value is €139,999 with an expected duration of 11 months and submission via the EU Funding & Tenders Portal (call EC-JRC/IPR/2026/MVP/3409-EXA). Eligible applicants are laboratories or research organisations with demonstrated in vitro ADME capability, quality systems and LC-MS/MS analytical capacity.

What it funds

Scope

Contract to implement two in vitro ADME methods (intrinsic hepatic clearance and plasma protein binding), generate high-quality experimental data for a defined set of chemicals using JRC Standard Operating Procedures (SOPs), and critically assess the tenderer laboratory's implementation of the SOPs. Apply via the Funding & Tenders Portal Tender details ¹.

Who can apply:Laboratories or service providers with validated in vitro ADME capabilities, appropriate quality systems and capacity to run the two assays under harmonised conditions and to follow JRC SOPs.

1. 1Perform intrinsic hepatic clearance assays according to JRC SOPs
2. 2Perform plasma protein binding (PPB) assays according to JRC SOPs
3. 3Generate, quality-control and deliver experimental data for selected chemicals
4. 4Provide a laboratory-specific critical assessment of SOP implementation and any deviations

This is a procurement (tender) for services. Proposals must demonstrate laboratory competence, adherence to the provided SOPs, quality assurance, and capacity to deliver traceable experimental data and an implementation assessment. Full tender documents and submission instructions are on the portal Tender details ¹.

Footnotes

1. 1Source: EU Funding & Tenders Portal tender notice EC-JRC/IPR/2026/MVP/3409-EXA, available at the official tender page.

Tender summary and objectives

Scope and primary objectives

This is a procurement tender issued by the European Commission Joint Research Centre (DG JRC) to implement two in vitro ADME methods: an intrinsic hepatic clearance assay and a plasma protein binding (PPB) assay. The supplier (tenderer) is required to run both assays for a defined set of selected chemicals following JRC-provided Standard Operating Procedures (SOPs). The primary objective is the generation of robust, high-quality, harmonised in vitro ADME data under controlled laboratory conditions, strictly adhering to all critical procedural components specified in the JRC SOPs. A secondary objective is to critically assess and report on the tenderer laboratory-specific implementation of the SOPs, identifying deviations, practical bottlenecks and recommendations for optimisation.

Lead contracting authority:European Commission, DG JRC - Joint Research Centre (JRC).

Contract type and procurement details:Services contract (procurement of laboratory services for in vitro ADME testing). Main CPV codes: 73200000, 73110000, 73111000. The planned contract duration is 11 months. Submission is via the Funding and Tenders Portal eSubmission system. Estimated total/overall contract amount: €139,999 ¹.

Eligibility, funding and administrative details

The tender is published on the EU Funding & Tenders Portal under call identifier EC-JRC/IPR/2026/MVP/3409-EXA. The tender uses the eSubmission channel of the Funding & Tenders Portal. The tender is part of EU-funded programmes managed by the JRC and is not marked as SME-suitable. The procurement is scheduled with an estimated planned date 2026-08-04 and an EXA registration deadline for submissions 2026-08-03 (Europe/Rome timezone).

Estimated value and duration:Estimated overall contract amount is €139,999 and the planned contract duration is 11 months. The planned start/award timeframe is indicated around 2026-08-04.

Eligible Applicant Types

The tender text does not list an exhaustive eligibility list of entity types but, based on the nature of the service (specialised laboratory ADME testing) and standard JRC procurement practice, eligible applicants typically include commercial contract research organisations (CROs), private testing laboratories, university-affiliated laboratories, research institutes, and other legal entities able to sign public contracts with the European Commission. Micro and small enterprises are not specifically favoured (smeSuitableIndicator: false). Non-profits and public sector laboratories may apply provided they meet procurement and qualification requirements.

Funding Type

This is a procurement service contract. The financial mechanism is a public purchase of services (tender/procurement). The tender results in payment for services delivered under contractual terms rather than a grant, loan, equity or prize.

Consortium Requirement

The provided metadata does not explicitly require a consortium. The procurement project lot (PAR-0001) describes a single services contract. Therefore the opportunity appears to accept single bidders or legal entities able to fulfil the full contract. If bidders intend to subcontract specific tasks or form consortia, such arrangements must comply with contracting authority rules and be clearly documented in the tender submission. The tender documentation should be checked for any mandatory consortium or minimum capacity requirements.

Beneficiary Scope (Geographic Eligibility)

This is an EU public procurement managed by the JRC. The tender is published on the EU Funding & Tenders Portal and therefore subject to EU procurement rules. While specific nationality or location eligibility is not explicitly included in the scraped text, standard EU procurement practice typically allows bidders established in EU Member States and may allow bidders from EEA/EFTA and, depending on contract notices, third countries where the EU procurement rules apply. Tenderers must consult the full tender specification and contract notice to confirm exact geographic eligibility and any required registrations.

Target Sector

Sector focus:preclinical in vitro ADME/PK testing relevant to regulatory science and chemical safety assessment. The work intersects chemical safety/toxicology, pharmacokinetics, assay validation and laboratory services. Relevant thematic areas: biotech/medtech, toxicology, chemical safety, laboratory services, regulatory science, alternatives to animal testing.

Mentioned Countries

No individual countries are explicitly named in the tender description beyond the contracting authority (European Commission, DG JRC). Geographic references in the metadata indicate Europe timezones (Europe/Rome, Europe/Brussels) and EU administration. Therefore the practical regional scope is EU/European context; bidders should verify nationality/establishment eligibility in the full tender documents.

Project Stage and Technical Maturity

Expected project stage:method implementation, validation/optimisation and data generation. This is not an early-stage research grant: it requires operational laboratory capacity to perform standardised in vitro ADME assays under JRC SOPs and produce high-quality experimental data and a critical implementation assessment. TRL-style maturity: applied laboratory implementation and demonstration (validation/standardisation stage).

Funding Amount (Range/Scale)

Estimated overall contract amount given in the procurement metadata is €139,999. No multiple-award structure is indicated; the amount likely corresponds to the single lot (PAR-0001).

Application Type and Submission Method

Submission type:open tender posted on the EU Funding & Tenders Portal. Submission method code: ESUBMISSION (electronic submission via the Funding and Tenders Portal). The portal's eForms/eSubmission tool is indicated as the access tool to upload proposals and required documents.

Nature of Support

Recipients will receive monetary compensation for delivered services under a services procurement contract. The contract requires delivery of laboratory services, experimental data sets and a critical assessment report. No non-financial support (such as coaching or vouchers) is indicated in the metadata; the support is contractual payment for services.

Application Stages

The metadata does not specify multiple evaluation rounds. Typical EU services tenders follow a single-stage submission followed by administrative and technical evaluation, possibly with a clarification phase. The available information implies at least one formal submission stage (electronic tender submission) and subsequent evaluation by the contracting authority. Bidders should consult the full tender dossier for the exact number and sequence of evaluation stages.

Success Rates

No success rate or number of expected awards is provided in the metadata. The tender indicates a single lot and an estimated overall contract value corresponding to one award. Success probability therefore depends on competition; no historical success rate data is present in the scraped content.

Co-funding Requirement

No co-funding from the tenderer is indicated. This is a fee-for-service procurement; bidders price their offer to cover costs and margin. Any required financial guarantees, declarations, or bank guarantees will be specified in the tender documents. Bidders must check the full contract terms to confirm whether any advance payments, retention, or financial securities are required.

Technical and scientific requirements (as can be inferred)

Key technical expectations derived from the description:adherence to JRC-provided SOPs for intrinsic hepatic clearance and plasma protein binding; demonstrated capability to perform in vitro ADME assays with documented quality control and data management; capacity to test a defined set of chemicals and generate harmonised, reproducible datasets; capability to produce a critical laboratory-specific implementation assessment describing deviations from SOPs, sources of variability, corrective actions, and recommendations for SOP refinement or lab practice harmonisation.

1. 1Perform intrinsic hepatic clearance assays according to JRC SOPs.
2. 2Perform plasma protein binding (PPB) assays according to JRC SOPs.
3. 3Generate high-quality experimental data for a defined set of chemicals.
4. 4Operate under controlled and harmonised laboratory conditions (QC, documentation).
5. 5Provide a critical assessment/report on the laboratory-specific implementation of the SOPs, including identified issues and recommendations.

Administrative and submission checklist (recommended)

Based on the procurement metadata and common EU tender requirements, bidders should prepare the following for submission via the Funding & Tenders Portal eSubmission: legal entity registration and eligibility documents, financial capacity evidence, technical capacity and personnel CVs, laboratory accreditation/certificates if available (ISO/GLP or equivalent), detailed methodology and quality assurance plan showing how the JRC SOPs will be implemented, timeline and workplan for the 11-month period, detailed costing and price breakdown to match the procurement conditions, subcontracting declarations if relevant, and a critical assessment plan for SOP implementation reporting.

Templates and application form structure (guidance):The tender uses the Funding & Tenders Portal eSubmission system and eForms templates. While the scraped content does not include the actual eForm fields, applicants should expect standard sections: administrative data (entity identification), tender response cover letter, declaration of honour, legal and financial capacity evidence, technical offer (workplan, methodology, personnel, facilities, QA/QC procedures), commercial offer (price breakdown), and annexes (CVs, certificates, SOP compliance table, data management plan). It is recommended to prepare a compliance matrix linking each JRC SOP step to the tenderer implementation procedure, and a sample data reporting template to ensure transparency and traceability.

Recommended bidder capabilities and documentation

To be competitive, bidders should demonstrate:validated laboratory infrastructure for in vitro ADME assays; experienced scientific personnel in hepatic clearance and protein binding assays; quality management systems (GLP, ISO or equivalent); robust data handling and reporting systems; previous experience delivering comparable datasets for regulatory or research organisations; capacity to critically review SOP implementation and produce actionable recommendations; ability to meet timelines and provide clear deliverables.

What is not specified in the scraped metadata (items to verify in full tender dossier)

• Exact list and identities of the selected chemicals to be tested.
• Detailed deliverables, data formats and reporting templates required by JRC.
• Award criteria and weighting (technical/financial split).
• Minimum qualification thresholds, exclusion or selection criteria.
• Any preference or restrictions regarding bidder nationality or establishment.
• Payment schedule, invoicing and contractual terms and conditions.
• Required insurance, guarantees or bank securities.

Bidders must consult the full tender documentation (call documents, instructions to tenderers, eForms and contract draft) available on the Funding & Tenders Portal for complete requirements, award criteria, and contractual conditions before preparing their submission. The portal will host all mandatory forms and any clarifications or updates.

Concluding summary

This opportunity is a single-lot public procurement by the European Commission JRC to contract a laboratory service provider to implement two JRC SOP-based in vitro ADME assays (intrinsic hepatic clearance and plasma protein binding), produce harmonised high-quality experimental data for a defined set of chemicals, and provide a critical assessment on how the SOPs were implemented within the tenderer’s laboratory. The contract is planned for approximately 11 months with an estimated total value of €139,999. Submission is via the Funding & Tenders Portal eSubmission system with registration/submission deadline 2026-08-03. The tender suits contract research organisations, specialised testing laboratories, or research institutes with demonstrated capacity in in vitro ADME testing, quality assurance and regulatory-facing data generation. Full tender documentation must be consulted to obtain the chemical list, deliverable specifications, award criteria and contractual terms prior to bid preparation.

Footnotes

1. 1Tender reference and source details available at the Funding & Tenders Portal: Tender details.

Opportunity Summary and Objectives

This tender seeks a service provider to implement two specific in vitro ADME methods:determination of **intrinsic hepatic clearance** and **plasma protein binding (PPB)** for a defined set of chemicals, adhering strictly to Joint Research Centre (JRC) Standard Operating Procedures (SOPs) [1][7]. The primary goal is to generate **robust, high-quality experimental data** under harmonized laboratory conditions to support protocol optimization [1]. A secondary objective involves the tenderer performing a **critical assessment** of how their facility implements the JRC-provided SOPs [1].

Key Scientific Focus:The study focuses on **in vitro-to-in vivo extrapolation (IVIVE)**, where intrinsic clearance (CLint) measured in the lab is scaled to predict human hepatic clearance, requiring correction for plasma protein binding to ensure accuracy [2][6].

Who Can Apply

Eligible Applicants

Eligible applicants are **laboratories and research organizations** with the technical capacity to perform advanced in vitro ADME assays using human-relevant approaches, such as hepatocytes or liver microsomes [1][17]. The tenderer must demonstrate the ability to adhere to strict JRC SOPs and possess the infrastructure for **controlled, harmonized laboratory conditions** [1].

1. 1Proven expertise in in vitro hepatic clearance assays (e.g., using hepatocytes or microsomes)
2. 2Experience with plasma protein binding determination (e.g., equilibrium dialysis or ultrafiltration)
3. 3Capability to validate and critically assess SOP implementation within their own facilities
4. 4Access to high-quality analytical instrumentation (e.g., LC-MS/MS) for compound quantification

Technical Requirements and Scope

Methodological Standards

All procedures must follow **JRC-provided SOPs**, which serve as the mandatory methodological foundation for the study [1]. Critical procedural components for assay integrity must be strictly adhered to, including specific solvent preparations (e.g., DMSO) and dilution ranges as defined in related TSAR SOPs [11].

Required Assays:1. **Intrinsic Hepatic Clearance**: Measured via substrate depletion in incubations with human liver microsomes or hepatocytes, calculating clearance rates based on parent compound disappearance [2][17]. 2. **Plasma Protein Binding (PPB)**: Determined using methods like **equilibrium dialysis** or rapid equilibrium dialysis (RED) to quantify the free fraction (fu) of the drug [17][20].

Data Quality and Validation

The tenderer must generate **high-quality experimental data** and perform a critical assessment of their SOP implementation, ensuring data meets performance criteria for validation [1][13]. Statistical treatment of data, including verification of normal distribution (Shapiro-Wilk test) and detection of anomalous data (Grubbs or Dixon tests), is required [13].

Application Process and Contract Details

Tender Type and Authority

This is an **open invitation to tender** issued by the **European Commission**, specifically under the framework of the Joint Research Centre (JRC) and potentially linked to EURL ECVAM's toxicokinetics strategy [1][7]. The opportunity is part of a broader effort to advance **New Approach Methodologies (NAMs)** and reduce animal testing in chemical risk assessment [5][12].

Official Portal:Applications and full technical specifications are available via the **EU Funding & Tenders Portal** at the provided opportunity URL EU Tender Portal.

Key Considerations for Applicants

• Applicants must be prepared to validate their facility's adherence to JRC SOPs as part of the secondary objective
• The study supports **protocol optimisation**, meaning data quality directly impacts future regulatory or research methodologies
• Human-relevant in vitro models are preferred to ensure data applicability to human hepatic clearance prediction [1][2]
• Analytical methods must include LC-MS/MS for precise quantification of parent compounds and free/bound fractions [17][20]

Footnotes

1. 1The JRC-provided SOPs are the mandatory standard for this study, ensuring harmonization across laboratories for regulatory data generation [1][7].
2. 2In vitro-to-in vivo extrapolation (IVIVE) requires correcting intrinsic clearance for plasma protein binding to accurately predict human hepatic clearance [2][6].