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ACT2 Study

No classification published
Location not published
Published value
Not published
Submission deadline Not published
Lots published1
Procurement Executive Summary
AI & Search Synopsis
Generated from official OCDS record
Tenderline Synopsis: THE UNIVERSITY OF BIRMINGHAM: "ACT2 Study". Published status: complete. Published value: Value not published. 1 published lot. Submission deadline not published. See the official notice for participation instructions.
Contracting AuthorityTHE UNIVERSITY OF BIRMINGHAMScope & CategoriesNot publishedSubmission Window
complete
No deadline published
Submission GatewayDirect notice routeLegal Basis & RegimeStandard procurementEstimated Value (exc. VAT)Not published
Bidder Intelligence · Authority Profile: THE UNIVERSITY OF BIRMINGHAM
Market Analytics
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Derived from OCDS awards & bid statistics
Published history for THE UNIVERSITY OF BIRMINGHAM. These figures describe retained records, not a forecast of bids or a measure of buyer bias.
Published-to-award variance
Not availableInsufficient comparable data
Requires at least 5 comparable procedures
Competition Density
3.4Bids / Report
48.4% of reports have one bid
Supplier ConcentrationNo estimate
Insufficient attributable awardsNo concentration estimate available
Payment Terms
Check noticePublished terms
Payment obligations depend on the applicable regime and contract. Consult the official documents.
Coverage: 152 active published awards; 31 bid reports (which may be per lot). Supplier values exclude multi-supplier awards, frameworks and DPS, and use GBP only. They are published award values, not payments. Published-to-award variance compares single-lot, single-award, single-supplier GBP procedures with explicitly non-framework/non-DPS status; increases remain in the average. Unpublished data stays unknown. Awarded suppliers are winners, not all bidders.
Procedure terms
Contracting AuthorityTHE UNIVERSITY OF BIRMINGHAM
Procedure methodNot published
Procurement categoryNot published
Statuscomplete
Framework / DPSNot published
CompetitionNot published
Above thresholdNot published
Legal basisNot published
Tender period startsNot published
Clarification deadlineNot published
Electronic submissionNot published
Submission languagesNot published
Published14 Jul 2025, 09:40 BST
Last source update14 Jul 2025, 09:40 BST
Recurring procurementNot published
ClassificationNot published
Delivery areaLocation not published
OCIDocds-h6vhtk-055e22
What is being bought
University of Birmingham (UoB) is the sponsor of ACT2 (Allogeneic Chondrocyte Therapy - A phase 2a study), an MRC funded project (MR/V027670/1). The study commenced in 2021 with the aim to develop and manufacture an allogeneic chondroprogenitor cell therapy from fresh osteochondral allografts in order to treat cartilage lesions in a single surgery. The study requires a manufacturing facility that can work with the research team to develop and validate the manufacturing process of the cell therapy product to a standard that can gain MHRA approval and thus enable the commencement of a Phase 2a human trial. Due to unforeseen circumstances, previously contracted GMP manufacturers are no longer able to manufacture the cell therapy product and, thus an alternative manufacturing facility is required expeditiously. The UoB team must operate within the restrictions placed upon them by the funder and the current project plan. In addition to this, the administrative burden as a consequence of BREXIT makes the use of a UK laboratory the only viable option. The Newcastle Advanced Therapies Facility has the unique requirements to deliver the project within the financial and time restrictions facing the project.
What changed
From the official release history
  1. Status changed to complete
    14 Jul 2025, 09:40 BST
  2. Official notice release published
    14 Jul 2025, 09:40 BST
  3. Buyer information updated
    14 Jul 2025, 09:40 BST
Lots and requirements (1)
Published by the contracting authority
  • Lot 1 · #1
    Individual lot title not published
    complete
    Published valueNot published
    The source published no individual title or description for this lot.
    Contract periodNot published
    EligibilityNot published
    Options / renewalNot published
Timeline
  1. Procedure published
    14 Jul 2025, 09:40 BST
  2. Award pending
    Not published · £515,318
Commercial outcome and competition
Awards
Newcastle Hospitals NHS Foundation Trust (Newcastle Advanced Therapies)
£515,318 · Not published · pending
ContractsNo contract published
Bid statisticsNo aggregate bid statistics published
Buyer and organisations in this procedure

THE UNIVERSITY OF BIRMINGHAM

Contracting authority GB-COH-RC000645
View buyer profile

  • THE UNIVERSITY OF BIRMINGHAM
    buyer

    GB-COH: RC000645 · GB-PPON: PHCQ-3464-LVTM
    Edgbaston, Birmingham, UKG31, B15 2TT, GB
    procurement@bham.ac.uk

  • Newcastle Hospitals NHS Foundation Trust (Newcastle Advanced Therapies)
    supplier

    GB-NHS: 86101
    FREEMAN ROAD, Newcastle Upon Tyne, UKC22, NE7 7DN, GB
    accounts.receivable@nuth.nhs.uk
Award and contract changes
Documents (1)
Official links; attachments are not copied

  • Not published

    tender
    conflictOfInterest
Related procedures (0)
No data
No related procedures published
Planning and rationale
Planning budgetNot published
No-engagement rationaleNot published
Procedure rationaleOur decision to exclusively source the Newcastle Advanced Therapies Facility (NATF) to manufacture the chondrocyte therapy is founded on several irrefutable factors. The Newcastle facility has a track-record in academic and commercial translational cell-therapy partnerships including DPFS funded programmes. They have successfully completed technical transfer and validation, compiled validation data and authored IMPDs for the successful submission and approval by the MHRA of several autologous and allogeneic products with some resulting in Phase I/II clinical trials. (EudraCT 2023-000020-11, EudraCT 2014-001476-63). The funding requirements and the current project status require the manufacturer to be in a position to commence manufacture within 4 months. Consequently, the project requires a dedicated clean room for the project, which NATF are able to provide with immediate effect. The NATF laboratory has been working with us on the project for the last 6 months in order to satisfy our Quality control testing for the project. NATF are therefore familiar with the project and the manufacture process. They are the only facility we are aware of that can provide, within the restricted budget, the GMP grade flow cytometry and Karyotype assay requirements. With regards to the additional QC testing requirements, the Newcastle team have close relationships underpinned with valid technical agreements with several contract laboratories and have worked with them to validate all the tests required for ACT2. QC test validation work undertaken to date is also directly transferrable (and does not require repeating), e.g. our mycoplasma product work-up with Mycoplasma Experience (also used by the Newcastle facility). This provides the researchers with the opportunity to rapidly transfer and implement manufacturing protocols, ensuring, as best as possible, that the future timelines of the project are met. It is anticipated that the manufacture protocols of the new therapy can be easily embedded within the facility and minimise the training requirements, hence facilitating a relatively early adoption.