Notice Information
Notice Title
LIONNS-D2 Project - Production of T3S API, IMP and FDF
Notice Description
Cardiff University's School of Medicine is procuring the manufacture of a novel investigational medicinal product (IMP), Triiodothyronine sulphate (T3S), for use in a Phase 2b clinical trial. The service includes the production of the active pharmaceutical ingredient (API), the IMP, and the finished drug formulation (FDF) in blister packs. This bespoke drug is intended for hypothyroid patients with a specific genetic variation affecting thyroid hormone metabolism. The supplier will manufacture the product to GMP standards, using a validated Route of Synthesis supported by existing preclinical and toxicology data.
Procurement Information
T3S is not commercially available and must be manufactured to GMP standards using a specific Route of Synthesis (RoS) supported by existing preclinical and toxicology data. Following extensive market engagement, Ardena NV has been identified as the only supplier capable of delivering the full scope of requirements: sourcing raw materials, manufacturing the Active Pharmaceutical Ingredient (API), producing the IMP, and packaging the Finished Drug Formulation (FDF) in blister packs. Other CDMOs approached were unable to meet the technical and regulatory requirements. The direct award is justified under the following provisions of Schedule 5 of the Procurement Act 2023: - The contract concerns the supply of novel goods for research and development purposes. - Due to technical reasons and absence of competition, only one supplier can meet the requirement. - There are no reasonable alternatives available.
Notice Details
Publication & Lifecycle
- Open Contracting ID
- ocds-h6vhtk-05d2df
- Publication Source
- Find A Tender Service
- Latest Notice
- https://www.find-tender.service.gov.uk/Notice/068032-2025
- Current Stage
- Award
- All Stages
- Award
Procurement Classification
- Notice Type
- UK6 - Contract Award Notice
- Procurement Type
- Standard
- Procurement Category
- Goods
- Procurement Method
- Direct
- Procurement Method Details
- Direct award
- Tender Suitability
- Not specified
- Awardee Scale
- Large
Common Procurement Vocabulary (CPV)
- CPV Divisions
33 - Medical equipments, pharmaceuticals and personal care products
-
- CPV Codes
33600000 - Pharmaceutical products
Notice Value(s)
- Tender Value
- Not specified
- Lots Value
- Not specified
- Awards Value
- £953,600 £500K-£1M
- Contracts Value
- Not specified
Notice Dates
- Publication Date
- 24 Oct 20254 months ago
- Submission Deadline
- Not specified
- Future Notice Date
- Not specified
- Award Date
- 21 Oct 20254 months ago
- Contract Period
- 6 Nov 2025 - 31 Jan 2027 1-2 years
- Recurrence
- Not specified
Notice Status
- Tender Status
- Complete
- Lots Status
- Complete
- Awards Status
- Pending
- Contracts Status
- Not Specified
Buyer & Supplier
Contracting Authority (Buyer)
- Main Buyer
- CARDIFF UNIVERSITY
- Contact Name
- Jamie Jones
- Contact Email
- jonesj156@cardiff.ac.uk, procurement@cardiff.ac.uk
- Contact Phone
- Not specified
Buyer Location
- Locality
- CARDIFF
- Postcode
- CF24 4HQ
- Post Town
- Cardiff
- Country
- Wales
-
- Major Region (ITL 1)
- TLL Wales
- Basic Region (ITL 2)
- TLL5 South East Wales
- Small Region (ITL 3)
- TLL52 Cardiff and Vale of Glamorgan
- Delivery Location
- Not specified
-
- Local Authority
- Cardiff
- Electoral Ward
- Cathays
- Westminster Constituency
- Cardiff South and Penarth
Further Information
Notice Documents
-
https://www.find-tender.service.gov.uk/Notice/068032-2025
24th October 2025 - Contract award notice on Find a Tender -
https://www.find-tender.service.gov.uk/Notice/067987-2025
23rd October 2025 - Transparency notice on Find a Tender
Open Contracting Data Standard (OCDS)
View full OCDS Record for this contracting process
The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts.
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