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

{
  "awards": [
    {
      "aboveThreshold": true,
      "contractPeriod": {
        "endDate": "2027-10-29T23:59:59+01:00",
        "startDate": "2025-10-29T00:00:00+00:00"
      },
      "documents": [
        {
          "datePublished": "2025-10-23T17:25:23+01:00",
          "description": "Transparency notice on Find a Tender",
          "documentType": "awardNotice",
          "format": "text/html",
          "id": "067987-2025",
          "noticeType": "UK5",
          "url": "https://www.find-tender.service.gov.uk/Notice/067987-2025"
        }
      ],
      "id": "1",
      "items": [
        {
          "additionalClassifications": [
            {
              "description": "Pharmaceutical products",
              "id": "33600000",
              "scheme": "CPV"
            }
          ],
          "deliveryAddresses": [
            {
              "country": "GB",
              "countryName": "United Kingdom",
              "region": "UKL"
            }
          ],
          "id": "1",
          "relatedLot": "1"
        }
      ],
      "mainProcurementCategory": "goods",
      "milestones": [
        {
          "dueDate": "2025-10-28T23:59:59+00:00",
          "id": "1",
          "status": "scheduled",
          "type": "futureSignatureDate"
        }
      ],
      "relatedLots": [
        "1"
      ],
      "status": "pending",
      "suppliers": [
        {
          "id": "GB-PPON-PRMH-6467-WRPY",
          "name": "Ardena Holding NV"
        }
      ],
      "title": "LIONNS-D2 Project \u2013 Production of T3S API, IMP and FDF",
      "value": {
        "amount": 953600.0,
        "amountGross": 953600.0,
        "currency": "EUR"
      }
    }
  ],
  "buyer": {
    "id": "GB-PPON-PHVT-4343-HWYR",
    "name": "Cardiff University"
  },
  "date": "2025-10-23T17:25:23+01:00",
  "id": "067987-2025",
  "initiationType": "tender",
  "language": "en",
  "ocid": "ocds-h6vhtk-05d2df",
  "parties": [
    {
      "address": {
        "country": "GB",
        "countryName": "United Kingdom",
        "locality": "Cardiff",
        "postalCode": "CF24 4HQ",
        "region": "UKL22",
        "streetAddress": "Procurement Services"
      },
      "contactPoint": {
        "email": "jonesj156@cardiff.ac.uk",
        "name": "Jamie Jones"
      },
      "details": {
        "classifications": [
          {
            "description": "Public authority - sub-central government",
            "id": "publicAuthoritySubCentralGovernment",
            "scheme": "UK_CA_TYPE"
          },
          {
            "description": "Welsh devolved regulations apply",
            "id": "GB-WLS",
            "scheme": "UK_CA_DEVOLVED_REGULATIONS"
          }
        ],
        "url": "http://www.cardiff.ac.uk/business/why-work-with-us/for-suppliers"
      },
      "id": "GB-PPON-PHVT-4343-HWYR",
      "identifier": {
        "id": "PHVT-4343-HWYR",
        "scheme": "GB-PPON"
      },
      "name": "Cardiff University",
      "roles": [
        "buyer"
      ]
    },
    {
      "address": {
        "country": "BE",
        "countryName": "Belgium",
        "locality": "Gent",
        "postalCode": "9030",
        "region": "BE",
        "streetAddress": "Kleimoer 4"
      },
      "contactPoint": {
        "email": "info@ardena.com"
      },
      "details": {
        "scale": "large",
        "vcse": false
      },
      "id": "GB-PPON-PRMH-6467-WRPY",
      "identifier": {
        "id": "PRMH-6467-WRPY",
        "scheme": "GB-PPON"
      },
      "name": "Ardena Holding NV",
      "roles": [
        "supplier"
      ]
    }
  ],
  "tag": [
    "award",
    "contract"
  ],
  "tender": {
    "description": "Cardiff University\u2019s 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.",
    "documents": [
      {
        "description": "Not published",
        "documentType": "conflictOfInterest",
        "id": "conflictOfInterest"
      }
    ],
    "id": "CU.1623.RR",
    "legalBasis": {
      "id": "2023/54",
      "scheme": "UKPGA",
      "uri": "https://www.legislation.gov.uk/ukpga/2023/54/contents"
    },
    "lots": [
      {
        "id": "1",
        "status": "complete"
      }
    ],
    "procurementMethod": "direct",
    "procurementMethodDetails": "Direct award",
    "procurementMethodRationale": "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.\nFollowing 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.\nThe direct award is justified under the following provisions of Schedule 5 of the Procurement Act 2023:\n- The contract concerns the supply of novel goods for research and development purposes.\n- Due to technical reasons and absence of competition, only one supplier can meet the requirement.\n- There are no reasonable alternatives available.",
    "procurementMethodRationaleClassifications": [
      {
        "id": "prototypesDevelopment"
      }
    ],
    "status": "complete",
    "title": "LIONNS-D2 Project \u2013 Production of T3S API, IMP and FDF "
  }
}