---
title: "ACT2 Study"
ocid: "ocds-h6vhtk-055e22"
canonical_url: "https://d3tenders.com/contract/?ocid=ocds-h6vhtk-055e22"
markdown_url: "https://d3tenders.com/contract/ocds-h6vhtk-055e22.md"
json_url: "https://d3tenders.com/contract/ocds-h6vhtk-055e22.json"
source: "Find A Tender Service"
current_stage: "Award"
buyer: "THE UNIVERSITY OF BIRMINGHAM"
published: "2025-07-14"
---

# ACT2 Study

Buyer: THE UNIVERSITY OF BIRMINGHAM  
Current stage: Award  
OCID: ocds-h6vhtk-055e22

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## Summary

The University of Birmingham has completed a procurement process for the provision of a manufacturing facility for its ACT2 Study, an MRC-funded project focused on developing a chondrocyte therapy from allogeneic chondroprogenitor cells. This direct award contract, valued at approximately £618,381.74, has been granted to the Newcastle Hospitals NHS Foundation Trust, specifically its Newcastle Advanced Therapies Facility. The need for urgency due to previous GMP manufacturers' inability to deliver, along with BREXIT-imposed constraints, necessitated this direct award. The procurement process was completed, and the contract covers the period from 31st July 2025 to 1st August 2026 in the UK, with a specific focus on services provided by medical personnel.

This tender offers significant opportunities for businesses in the medical and biotechnological sectors, particularly those involved in cell therapy and related scientific research. Organisations with capabilities in providing high-standard manufacturing facilities for therapeutic products, especially in regulatory compliance and collaborative research work, are well-suited to benefit from similar opportunities. The Newcastle Advanced Therapies Facility's experience and existing technical agreements make it a strategic partner in advancing clinical trials and therapeutic products, underscoring the potential for business growth within this industry sector.

## Notice

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.

### Procurement Information

Our 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.

## Key Details

| Field | Value |
| --- | --- |
| Publication source | Find A Tender Service |
| Latest notice | https://www.find-tender.service.gov.uk/Notice/039471-2025 |
| Notice type | UK5 - Transparency Notice |
| Procurement type | Standard |
| Procurement category | Services |
| Procurement method | Direct |
| Procurement method details | Direct award |
| Tender suitability | SME |
| Awardee scale | Large |
| All stages | Award |

## Dates

| Field | Value |
| --- | --- |
| Publication date | 14 Jul 2025 |
| Submission deadline | Not specified |
| Future notice date | Not specified |
| Award date | 14 Jul 2025 |
| Contract period | 30 Jul 2025 - 1 Aug 2026 |
| Recurrence | Not specified |

## Values

| Field | Value |
| --- | --- |
| Tender value | Not specified |
| Lots value | Not specified |
| Awards value | £515,318 |
| Contracts value | Not specified |

## Status

| Field | Value |
| --- | --- |
| Tender status | Complete |
| Lots status | Complete |
| Awards status | Pending |
| Contracts status | Not specified |

## Buyer

| Field | Value |
| --- | --- |
| Main buyer | THE UNIVERSITY OF BIRMINGHAM |
| Locality | BIRMINGHAM |
| Post town | Birmingham |
| Postcode | B15 2TT |
| Country | England |
| ITL 1 | TLG West Midlands (England) |
| ITL 2 | TLG3 West Midlands |
| ITL 3 | TLG31 Birmingham |
| Local authority | Birmingham |
| Electoral ward | Edgbaston |
| Westminster constituency | Birmingham Edgbaston |
| Delivery location | Not specified |

## Supplier

| Field | Value |
| --- | --- |
| Number of suppliers | 1 |
| Supplier names | NEWCASTLE HOSPITALS NHS FOUNDATION TRUST (NEWCASTLE ADVANCED THERAPIES |

## CPV Codes

### Divisions

- 85 - Health and social work services

### Codes

- 85141000 - Services provided by medical personnel

## Release History

- 14 Jul 2025 at 08:40 - Award - UK5 - Transparency Notice - https://www.find-tender.service.gov.uk/Notice/039471-2025

## Documents

- https://www.find-tender.service.gov.uk/Notice/039471-2025
  14th July 2025 - Transparency notice on Find a Tender

## Notice URLs

- http://www.birmingham.ac.uk
- https://www.legislation.gov.uk/ukpga/2023/54/contents

## Provenance

This Markdown file is an alternate public rendering of the D3 Tenders contract record. The canonical page is https://d3tenders.com/contract/?ocid=ocds-h6vhtk-055e22. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-h6vhtk-055e22.json.
