ProcuraAxisBeta
Sign inCreate Free Account
Home / Opportunities / Opportunity
PROCUREMENT OPPORTUNITY

ACT2 Study

THE UNIVERSITY OF BIRMINGHAM · Transparency notice on Find a Tender

Tender information last checkedLast checked 30 Sept 2026, 05:50.

Opportunity overview

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.

Awarded to

Amounts belong to published awards or contracts. Where several suppliers share one value, it is labelled as shared and is not a supplier-specific allocation.

Classification

No classification was supplied.

Lots

  • Lot 1Value not stated

Documents and notices

Published notice details

Additional information from the published procurement release. Fields appear only when supplied by the source; check the original notice and tender documents before acting.

Scope, procedure and submissions

Id
ocds-h6vhtk-055e22
Status
complete
Procurement Method
direct
Procurement Method Details
Direct award
Why this procedure was chosen
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.

Legal basis

Id
2023/54
Scheme
UKPGA

Procedure reasons

Entry 1
Id
urgency

Lots and requirements

Entry 1
Id
1
Status
complete

Suitability

Sme
Yes

Published documents

Entry 1
Id
conflictOfInterest
Description
Not published
Document Type
conflictOfInterest

Buyer, suppliers and contacts

Organisation 1
Id
GB-COH-RC000645
Name
THE UNIVERSITY OF BIRMINGHAM

Roles

buyer

Address

Region
UKG31
Country
GB
Locality
Birmingham
Postal Code
B15 2TT
Country Name
United Kingdom
Street Address
Edgbaston

Details

Classifications

Entry 1
Id
publicAuthoritySubCentralGovernment
Scheme
UK_CA_TYPE
Description
Public authority - sub-central government

Identifier

Id
RC000645
Scheme
GB-COH

Contact

Additional Identifiers

Entry 1
Id
PHCQ-3464-LVTM
Scheme
GB-PPON
Organisation 2
Id
GB-NHS-86101
Name
Newcastle Hospitals NHS Foundation Trust (Newcastle Advanced Therapies)

Roles

supplier

Address

Region
UKC22
Country
GB
Locality
Newcastle Upon Tyne
Postal Code
NE7 7DN
Country Name
United Kingdom
Street Address
FREEMAN ROAD

Details

Vcse
No
Scale
large

Identifier

Id
86101
Scheme
GB-NHS

Contact

Award information

Award 1
Id
1
Status
pending
Above Threshold
Yes
Main Procurement Category
services

Items

Item 1
Id
1
Related Lot
1

Delivery locations

Entry 1
Region
UK
Country
GB
Country Name
United Kingdom

Additional Classifications

Entry 1
Id
85141000
Scheme
CPV
Description
Services provided by medical personnel

Value

Amount
515,318.12
Currency
GBP
Including VAT
618,381.74

Documents

Entry 1
Id
039471-2025
Format
text/html
Notice Type
UK5
Description
Transparency notice on Find a Tender
Document Type
awardNotice
Published
14 Jul 2025, 09:40

Suppliers

Supplier 1
Id
GB-NHS-86101
Name
Newcastle Hospitals NHS Foundation Trust (Newcastle Advanced Therapies)

Milestones

Entry 1
Id
1
Type
futureSignatureDate
Status
scheduled
Due
22 Jul 2025, 23:59

Related lots

1

Contract period

Ends
1 Aug 2026, 23:59
Starts
31 Jul 2025, 00:00

Recorded locations

  • Buyer location · Birmingham · UKG31 · B15 2TT · United Kingdom

Notice and amendment history

1 published notice version reviewed by ProcuraAxis.

1 VERSION
  1. ocds-h6vhtk-055e22-2025-07-14T09:40:28+01:00Transparency notice on Find a Tender ·