LIONNS-D2 Project – Production of T3S API, IMP and FDF

Procurement reference

CU.1623.RR

Procurement 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.

Cardiff University

Ardena Holding NV

Procedure type

Direct award

Description of how these justifications apply

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.

Direct award justification

Prototypes development