Scope
Reference
CU.1623.RR
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.
Contract 1. LIONNS-D2 Project – Production of T3S API, IMP and FDF
Supplier
Contract value
- 953600.00 EUR excluding VAT
- 953600.00 EUR including VAT
Above the relevant threshold
Earliest date the contract will be signed
28 October 2025
Contract dates (estimated)
- 29 October 2025 to 29 October 2027
- 2 years, 1 day
Main procurement category
Goods
CPV classifications
- 33600000 - Pharmaceutical products
Contract locations
- UKL - Wales
Other information
Conflicts assessment prepared/revised
Yes
Procedure
Procedure type
Direct award
Direct award justification
Prototypes and development
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.
Supplier
Ardena Holding NV
- Public Procurement Organisation Number: PRMH-6467-WRPY
Kleimoer 4
Gent
9030
Belgium
Email: info@ardena.com
Small or medium-sized enterprise (SME): No
Voluntary, community or social enterprise (VCSE): No
Contract 1. LIONNS-D2 Project - Production of T3S API, IMP and FDF
Contracting authority
Cardiff University
- Public Procurement Organisation Number: PHVT-4343-HWYR
Procurement Services
Cardiff
CF24 4HQ
United Kingdom
Contact name: Jamie Jones
Email: jonesj156@cardiff.ac.uk
Website: http://www.cardiff.ac.uk/business/why-work-with-us/for-suppliers
Region: UKL22 - Cardiff and Vale of Glamorgan
Organisation type: Public authority - sub-central government
Devolved regulations that apply: Wales