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

{
  "buyer": {
    "id": "GB-FTS-2023",
    "name": "University Of Edinburgh"
  },
  "date": "2025-07-30T11:13:55+01:00",
  "description": "Any supplier who wishes to participate should enrol on PCST and complete their tender (including Qualification, Technical and Commercial) by the prescribed deadline).\nWe encourage all suppliers to carefully read the specification; consider their prior experience, and whether they can substantially meet the cost appetite set out prior to tendering.\nIn the event a supplier does not pass Qualification evaluation the University may elect to not review the rest of their bid.\nThe buyer is using PCS-Tender to conduct this ITT exercise. The Project code is 29817. For more information see: http://www.publiccontractsscotland.gov.uk/info/InfoCentre.aspx?ID=2343\nCommunity benefits are included in this requirement. For more information see: https://www.gov.scot/policies/public-sector-procurement/community-benefits-in-procurement/\nA summary of the expected community benefits has been provided as follows:\nWe encourage suppliers to make an offer however we recognise business norms differ by region and this may not always be possible.  Suppliers who wish to consider social value as part of their tender may review options for doing so in Schedule 9B of the procurement documentation.\n(SC Ref:805770)",
  "id": "044163-2025",
  "initiationType": "tender",
  "language": "en",
  "links": [
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  "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",
        "url": "https://www.publictendersscotland.publiccontractsscotland.gov.uk/"
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      "details": {
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        "classifications": [
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            "description": "Body governed by public law",
            "id": "BODY_PUBLIC",
            "scheme": "TED_CA_TYPE"
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          {
            "description": "Education",
            "id": "09",
            "scheme": "COFOG"
          }
        ],
        "url": "http://www.ed.ac.uk"
      },
      "id": "GB-FTS-2023",
      "identifier": {
        "legalName": "University Of Edinburgh"
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      "name": "University Of Edinburgh",
      "roles": [
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    {
      "address": {
        "countryName": "United Kingdom",
        "locality": "Edinburgh"
      },
      "id": "GB-FTS-1033",
      "identifier": {
        "legalName": "Edinburgh Sheriff Court"
      },
      "name": "Edinburgh Sheriff Court",
      "roles": [
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  ],
  "tag": [
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  "tender": {
    "classification": {
      "description": "Medical specialist services",
      "id": "85121200",
      "scheme": "CPV"
    },
    "contractTerms": {
      "electronicInvoicingPolicy": "allowed",
      "hasElectronicOrdering": true,
      "hasElectronicPayment": true,
      "performanceTerms": "Supplier shall be required to progress the contract in line with any agreed terms and quality criteria. Supplier to conduct themselves fully in line with the regulations and laws of their operational territory and in compliance with the laws of the State of California"
    },
    "coveredBy": [
      "GPA"
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    "description": "We are planning a phase I/II clinical trial to treat a rare genetic disease that causes progressive dementia in children. Our therapy will use autologous CD34+ haematopoietic stem progenitor cells (HSPCs) which are modified ex vivo with LVV to express supraphysiologic levels of a secreted enzyme.\nIn order to progress this therapy, we require a high titre LVV produced to good manufacturing practice (GMP) standard. The supplier must have extensive previous experience manufacturing LVVs to this specification which have achieved regulatory approval 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 the 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 analogous to the American English term \u2018Titer\u2019 and the spellings may be used interchangeably.\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), transport, and other supplier project costs such as (but not limited to) quality control testing and audit.\nThe cost estimate of the procurement reflects the anticipated cost of the initial requirement plus contingency, for (for example but not limited to), 1. Scope extension, 2. Additional ad-hoc delivery to support further trials.\nThe time frame of the agreement \u2013 3 years, reflects an initial delivery period expected to be no longer than 12 months post signature, and the option to buy additional deliveries for two years thereafter. The University may award additional deliveries to the awarded supplier via the Negotiated Procedure Without Prior Call for Competition.\nFor transparency we have a budget appetite of approximately USD560k for the delivery of the 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 if the ultimate procurement procedure is re-run) under reduced timescales as set out in the regulations.",
    "documents": [
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    "hasRecurrence": false,
    "id": "ocds-h6vhtk-0568ca",
    "items": [
      {
        "deliveryAddresses": [
          {
            "region": "UKM75"
          },
          {
            "region": "US"
          }
        ],
        "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"
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    ],
    "legalBasis": {
      "id": "32014L0024",
      "scheme": "CELEX"
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    "lots": [
      {
        "awardCriteria": {
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            {
              "description": "50",
              "name": "Suitability to fulfil requirement",
              "type": "quality"
            },
            {
              "description": "50",
              "name": "Total cost",
              "type": "cost"
            }
          ]
        },
        "contractPeriod": {
          "durationInDays": 1080
        },
        "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 administer 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 the 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 transduction of 293T cells from a certified Master Cell Bank with genome and packaging plasmids supplied by the University\n- Able to concentrate this supernatant by a factor of approx. 100-200x to produce a concentrated high titre LVV\n- The supplier must have extensive prior experience of such manufacture and have achieved numerous regulatory approvals for use of their LVV products in phase I/II clinical trials. This is critical to ensure there is confidence that the supplier product will be acceptable 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 LVV products\n- Supplied should follow all relevant legislation applicable to this engagement including in their location/s of manufacture, and the State of California, USA\n- The supplier should demonstrate a manufacturing process which is compliant with GMP and 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 accountability we require a direct relationship with the manufacturing entity/lead and therefore bids proposed by an entity acting solely as a reseller/distributor will unfortunately not be acceptable for this requirement. It is our expectation that the bidder undertakes the manufacturing; however other functions like Quality Control may be undertaken by subcontractors providing that the bidder takes full ultimate responsibility for delivery of the contract.\n- The supplier should demonstrate a reasonable and practicable solution for logistical delivery of the product.\n- For transparency we have a budget appetite of approximately USD560k for the delivery of 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 (including manufacture, quality control and regulatory pack preparation), within 12 months or 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 from 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 project in relation to the product specification will remain vested in the University and its licensors and nothing in the awarded contract shall constitute granting a license, creating a joint endeavour, creating joint IP, or otherwise constituting a license or transfer of IP to the Supplier, that would entitle the Supplier to take any action utilising that IP beyond the bounds of the Services which will be agreed between the University and Supplier pursuant of this tender.",
        "hasOptions": true,
        "hasRenewal": false,
        "id": "1",
        "options": {
          "description": "The time frame of the agreement \u2013 3 years, reflects an initial delivery period expected to be no longer than 12 months post signature, and the option to buy additional deliveries for two years thereafter. The University may award additional deliveries to the awarded supplier via the Negotiated Procedure Without Prior Call for Competition."
        },
        "secondStage": {
          "minimumCandidates": 3
        },
        "selectionCriteria": {
          "description": "Any tenderer who passes the SPD and fulfils the minimum technical criteria may complete their ITT"
        },
        "status": "active",
        "submissionTerms": {
          "variantPolicy": "notAllowed"
        },
        "value": {
          "amount": 900000,
          "currency": "GBP"
        }
      }
    ],
    "mainProcurementCategory": "services",
    "procurementMethod": "selective",
    "procurementMethodDetails": "Competitive procedure with negotiation",
    "secondStage": {
      "invitationDate": "2025-09-01T00:00:00+01:00",
      "noNegotiationNecessary": true,
      "successiveReduction": true
    },
    "selectionCriteria": {
      "criteria": [
        {
          "appliesTo": [
            "supplier"
          ],
          "description": "Supplier must operate in a fashion compliant with USA GMP and be familiar with FDA approvals, having a significant prior record of successful lentiviral vector manufacture (10 years preferred) and regulatory (FDA preferred) approvals (50+ preferred).",
          "type": "suitability"
        },
        {
          "appliesTo": [
            "supplier"
          ],
          "description": "Should provide adequate confidence the supplier has required financial standing to fulfill the engagement.\nFurther requirement as set out in the procurement documentation",
          "type": "economic"
        }
      ]
    },
    "status": "active",
    "submissionMethod": [
      "electronicSubmission"
    ],
    "submissionMethodDetails": "https://www.publictendersscotland.publiccontractsscotland.gov.uk/",
    "submissionTerms": {
      "bidValidityPeriod": {
        "durationInDays": 120
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      "languages": [
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    "tenderPeriod": {
      "endDate": "2025-09-01T12:00:00+01:00"
    },
    "title": "Batch manufacture of high titer/titre GMP (U.S.A.) compliant lentiviral vector for FDA approval",
    "value": {
      "amount": 900000,
      "currency": "GBP"
    }
  }
}