Batch manufacture of high titer/titre GMP (U.S.A.) compliant lentiviral vector for FDA approval

{
  "awards": [
    {
      "id": "080811-2025-EC1057-1",
      "relatedLots": [
        "1"
      ],
      "status": "active",
      "suppliers": [
        {
          "id": "GB-FTS-168590",
          "name": "Indiana University"
        }
      ]
    }
  ],
  "bids": {
    "statistics": [
      {
        "id": "1",
        "measure": "bids",
        "relatedLot": "1",
        "value": 1
      },
      {
        "id": "2",
        "measure": "smeBids",
        "relatedLot": "1",
        "value": 0
      },
      {
        "id": "3",
        "measure": "foreignBidsFromEU",
        "relatedLot": "1",
        "value": 0
      },
      {
        "id": "4",
        "measure": "foreignBidsFromNonEU",
        "relatedLot": "1",
        "value": 1
      },
      {
        "id": "5",
        "measure": "electronicBids",
        "relatedLot": "1",
        "value": 1
      }
    ]
  },
  "buyer": {
    "id": "GB-FTS-2023",
    "name": "University Of Edinburgh"
  },
  "contracts": [
    {
      "awardID": "080811-2025-EC1057-1",
      "dateSigned": "2025-11-07T00:00:00Z",
      "id": "080811-2025-EC1057-1",
      "status": "active",
      "value": {
        "amount": 586904.0,
        "currency": "USD"
      }
    }
  ],
  "date": "2025-12-08T17:13:25Z",
  "description": "(SC Ref:817966)",
  "id": "080811-2025",
  "initiationType": "tender",
  "language": "en",
  "links": [
    {
      "href": "https://api.publiccontractsscotland.gov.uk/v1/Notice?id=ocds-r6ebe6-0000817966",
      "rel": "canonical"
    }
  ],
  "ocid": "ocds-h6vhtk-0568ca",
  "parties": [
    {
      "address": {
        "countryName": "United Kingdom",
        "locality": "Edinburgh",
        "postalCode": "EH1 1HT",
        "region": "UKM75",
        "streetAddress": "Charles Stewart House, 9-16 Chambers Street"
      },
      "contactPoint": {
        "email": "jpike2@ed.ac.uk",
        "telephone": "+44 1316502759"
      },
      "details": {
        "buyerProfile": "https://www.publiccontractsscotland.gov.uk/search/Search_AuthProfile.aspx?ID=AA00107",
        "classifications": [
          {
            "description": "Body governed by public law",
            "id": "BODY_PUBLIC",
            "scheme": "TED_CA_TYPE"
          },
          {
            "description": "Education",
            "id": "09",
            "scheme": "COFOG"
          }
        ],
        "url": "http://www.ed.ac.uk"
      },
      "id": "GB-FTS-2023",
      "identifier": {
        "legalName": "University Of Edinburgh"
      },
      "name": "University Of Edinburgh",
      "roles": [
        "buyer",
        "centralPurchasingBody"
      ]
    },
    {
      "address": {
        "countryName": "United States",
        "locality": "Bloomington",
        "postalCode": "47405",
        "region": "US",
        "streetAddress": "1024 East 3rd Street, Room 132"
      },
      "contactPoint": {
        "telephone": "+001 3172786518"
      },
      "details": {
        "scale": "large"
      },
      "id": "GB-FTS-168590",
      "identifier": {
        "legalName": "Indiana University"
      },
      "name": "Indiana University",
      "roles": [
        "supplier"
      ]
    },
    {
      "address": {
        "countryName": "United Kingdom",
        "locality": "Edinburgh"
      },
      "id": "GB-FTS-1033",
      "identifier": {
        "legalName": "Edinburgh Sheriff Court"
      },
      "name": "Edinburgh Sheriff Court",
      "roles": [
        "reviewBody"
      ]
    }
  ],
  "tag": [
    "award",
    "contract"
  ],
  "tender": {
    "classification": {
      "description": "Pharmaceutical products",
      "id": "33600000",
      "scheme": "CPV"
    },
    "coveredBy": [
      "GPA"
    ],
    "description": "We are planning a phase I/II clinical trial to treat a rare genetic disease that causes\nprogressive dementia in children. Our therapy will use autologous CD34+ haematopoietic\nstem progenitor cells (HSPCs) which are modified ex vivo with LVV to express\nsupraphysiologic levels of a secreted enzyme.\nIn order to progress this therapy, we require a high titre LVV produced to good\nmanufacturing practice (GMP) standard. The supplier must have extensive previous\nexperience manufacturing LVVs to this specification which have achieved regulatory\napproval for phase I/II clinical trials, ideally for use in human CD34+ HSPC transduction.\nThe QC defined must be performed in compliance with FDA regulations. The product of\nthe initial delivery will be delivered directly to the University of California, LA, USA.\nNote that throughout the document the British spelling \u2018Titre\u2019 has been used; this is\nanalogous to the American English term \u2018Titer\u2019 and the spellings may be used\ninterchangeably.\nThe University anticipates initially awarding for;\n- Manufacture of concentrated lentiviral vector (LVV) from a 30L viral harvest\n- Such award to include any warranties on quality, product replacement (for spoilage),\ntransport, and other supplier project costs such as (but not limited to) quality control\ntesting and audit.\nThe cost estimate of the procurement reflects the anticipated cost of the initial\nrequirement plus contingency, for (for example but not limited to), 1. Scope extension, 2.\nAdditional ad-hoc delivery to support further trials.\nThe time frame of the agreement \u2013 3 years, reflects an initial delivery period expected to\nbe no longer than 12 months post signature, and the option to buy additional deliveries for\ntwo years thereafter. The University may award additional deliveries to the awarded\nsupplier via the Negotiated Procedure Without Prior Call for Competition.\nFor transparency we have a budget appetite of approximately USD560k for the delivery of\nthe initial services. We may review this estimate from time to time.\nHaving posted this notice we reserve the right to repost any subsequent notice (including\nif the ultimate procurement procedure is re-run) under reduced timescales as set out in\nthe regulations.",
    "id": "EC1057",
    "items": [
      {
        "deliveryAddresses": [
          {
            "region": "US"
          },
          {
            "region": "UKM75"
          }
        ],
        "deliveryLocation": {
          "description": "Product is to be delivered to University of California, Los Angeles, U.S.A.\nContracting party University of Edinburgh is in Edinburgh, Scotland, UK"
        },
        "id": "1",
        "relatedLot": "1"
      }
    ],
    "legalBasis": {
      "id": "32014L0024",
      "scheme": "CELEX"
    },
    "lots": [
      {
        "awardCriteria": {
          "criteria": [
            {
              "description": "50",
              "name": "Suitability to fulfil requirement",
              "type": "quality"
            },
            {
              "description": "50",
              "name": "Total cost",
              "type": "cost"
            }
          ]
        },
        "description": "See procurement documentation for all un-abridged description.\nDEFINITIONS\nFDA is the U.S Food and Drug Administration (FDA); the regulator for new clinical drugs\nGMP means \u2018Good Manufacturing Practice\u2019; U.S.A.\nIND is an \u201cInvestigational New Drug Application\u201d; a request to the FDA to be permitted to\nadminister a new prototype drug on human patients for research purposes\nLentiviral vector (LVV) is a type of virus (retrovirus) that inserts its DNA into the cells of\nthe organism/person it infects.\nPlasmid is a small DNA molecule which stores non-chromosomal DNA.\nMust-have capabilities\n- Able to produce a 30L harvest of unconcentrated LVV-containing supernatant following\ntransduction of 293T cells from a certified Master Cell Bank with genome and packaging\nplasmids supplied by the University\n- Able to concentrate this supernatant by a factor of approx. 100-200x to produce a\nconcentrated high titre LVV\n- The supplier must have extensive prior experience of such manufacture and have\nachieved numerous regulatory approvals for use of their LVV products in phase I/II clinical\ntrials. This is critical to ensure there is confidence that the supplier product will be\nacceptable and well-received for regulatory approval.\no 10 years prior experience of manufacturing GMP-compliant LVV products\no Achieved minimum of 50 prior regulatory approvals (ideally FDA) of GMP-compliant\nLVV products\n- Supplied should follow all relevant legislation applicable to this engagement including in\ntheir location/s of manufacture, and the State of California, USA\n- The supplier should demonstrate a manufacturing process which is compliant with GMP\nand that gives high confidence of their ability to deliver a high quality, compliant, product.\n- For the purposes of greater transparency, collaboration and regulatory traceability and\naccountability we require a direct relationship with the manufacturing entity/lead and\ntherefore bids proposed by an entity acting solely as a reseller/distributor will unfortunately\nnot be acceptable for this requirement. It is our expectation that the bidder undertakes the\nmanufacturing; however other functions like Quality Control may be undertaken by\nsubcontractors providing that the bidder takes full ultimate responsibility for delivery of the\ncontract.\n- The supplier should demonstrate a reasonable and practicable solution for logistical\ndelivery of the product.\n- For transparency we have a budget appetite of approximately USD560k for the delivery\nof the initial services. We may review this estimate from time to time.\nDesirable criteria\n- It is desirable that the supplier can complete end to end delivery of initial requirement\n(including manufacture, quality control and regulatory pack preparation), within 12 months\nor faster from contract signature. Fast delivery times are desirable for the project.\n- It is desirable that the supplier takes full accountability for the transport of the product\nfrom the site of manufacture to UCLA.\nQuality control (\u2018QC\u2019);\nThis will require comprehensive GMP compliance QC to be performed:\nSupplier will be required to provide details of the GMP-compliant manufacturing process\nIntellectual property\nFor avoidance of doubt; the intellectual property (\u201cIP\u201d) the University provides during the\nproject in relation to the product specification will remain vested in the University and its\nlicensors and nothing in the awarded contract shall constitute granting a license, creating\na joint endeavour, creating joint IP, or otherwise constituting a license or transfer of IP to\nthe Supplier, that would entitle the Supplier to take any action utilising that IP beyond the\nbounds of the Services which will be agreed between the University and Supplier\npursuant of this tender.",
        "hasOptions": true,
        "id": "1",
        "options": {
          "description": "The time frame of the agreement \u2013 3 years, reflects an initial delivery period expected to\nbe no longer than 12 months post signature, and the option to buy additional deliveries for\ntwo years thereafter. The University may award additional deliveries to the awarded\nsupplier via the Negotiated Procedure Without Prior Call for Competition."
        },
        "status": "cancelled"
      }
    ],
    "mainProcurementCategory": "goods",
    "procurementMethod": "selective",
    "procurementMethodDetails": "Competitive procedure with negotiation",
    "status": "complete",
    "title": "Batch manufacture of high titer/titre GMP (U.S.A.) compliant lentiviral vector for FDA approval"
  }
}