Notice Information
Notice Title
ACT2 Project
Notice Description
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 UoB is 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 labaratory the only viable option. The OsCell Laboratory at The Robert Jones and Agnes Hunt Hospital (RJAH) has the unique requirements to deliver the project within the financial and time restrictions facing the project.
Lot Information
Lot 1
Our decision to exclusively source the OsCell laboratory to manufacture the chondrocyte therapy is founded on several irrefutable factors. The OsCell Laboratory is the only GMP facility within the UK who currently manufacture a GMP compliant chondrocyte therapy for clinic use. It is the most experienced laboratory in the UK for the manufacture of chondrocytes, with a proven track record of chondrocyte manufacture since 1997. OsCell is the only GMP laboratory in the UK with the necessary experience of process development and the validation of new therapies for cartilage repair, as well as producing cells for use in a clinical trial of a cell therapy for cartilage repair. RJAH and the OsCell Laboratory, together with Keele University, instigated and delivered the ACTIVE trial (ISRCTN48911177), which remains the largest clinical trial investigating a chondrocyte cell therapy in the world. In addition, the RJAH and OsCell Laboratory has just completed the ASCOT trial (ISRCTN98997175), a randomised controlled trial of autologous chondrocyte implantation vs. two mesenchymal stem cell (MSC) therapies, 1 of which was combined with chondrocytes. No other facility in the UK possesses the capability to furnish us with the complete suite of resources, knowledge, experience and support necessary to uphold the exceptional standards of research and innovation we strive to maintain. The funding requirements and the current project status require the manufacturer to be in a position to commence manufacture within 2 months. The location of the OsCell laboratory is unique in that it is on the same site as the Keele University researchers involved in the study. This provides the researchers with the opportunity to closely interact with the facility to enable rapid knowledge transfer and ensure, 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. In addition, the close proximity will allow for optimised training and practice, negating the need for additional ethical and administrative approvals. The use of any other facility would result in significant delays, particularly regarding training and administration, which would threaten the project timelines. The nature of the OsCell Laboratory facility is also unique in that only 1 research project at a time is accepted by the facility, guaranteeing the project will receive the necessary priority that the current imposed timelines necessitate. The Qualified Person (QP) involved in the project for the last 14 months would remain in place, ensuring continuity. No other facility can provide a QP with prior knowledge of the project and experience of currently supervising the release of manufactured chondrocytes for clinical use in a UK facility.
Procurement Information
Our decision to exclusively source the OsCell laboratory to manufacture the chondrocyte therapy is founded on several irrefutable factors. The OsCell Laboratory is the only GMP facility within the UK who currently manufacture a GMP compliant chondrocyte therapy for clinic use. It is the most experienced laboratory in the UK for the manufacture of chondrocytes, with a proven track record of chondrocyte manufacture since 1997. OsCell is the only GMP laboratory in the UK with the necessary experience of process development and the validation of new therapies for cartilage repair, as well as producing cells for use in a clinical trial of a cell therapy for cartilage repair. RJAH and the OsCell Laboratory, together with Keele University, instigated and delivered the ACTIVE trial (ISRCTN48911177), which remains the largest clinical trial investigating a chondrocyte cell therapy in the world. In addition, the RJAH and OsCell Laboratory has just completed the ASCOT trial (ISRCTN98997175), a randomised controlled trial of autologous chondrocyte implantation vs. two mesenchymal stem cell (MSC) therapies, 1 of which was combined with chondrocytes. No other facility in the UK possesses the capability to furnish us with the complete suite of resources, knowledge, experience and support necessary to uphold the exceptional standards of research and innovation we strive to maintain. The funding requirements and the current project status require the manufacturer to be in a position to commence manufacture within 2 months. The location of the OsCell laboratory is unique in that it is on the same site as the Keele University researchers involved in the study. This provides the researchers with the opportunity to closely interact with the facility to enable rapid knowledge transfer and ensure, 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. In addition, the close proximity will allow for optimised training and practice, negating the need for additional ethical and administrative approvals. The use of any other facility would result in significant delays, particularly regarding training and administration, which would threaten the project timelines. The nature of the OsCell Laboratory facility is also unique in that only 1 research project at a time is accepted by the facility, guaranteeing the project will receive the necessary priority that the current imposed timelines necessitate. The Qualified Person (QP) involved in the project for the last 14 months would remain in place, ensuring continuity. No other facility can provide a QP with prior knowledge of the project and experience of currently supervising the release of manufactured chondrocytes for clinical use in a UK facility.
Notice Details
Publication & Lifecycle
- Open Contracting ID
- ocds-h6vhtk-0457fb
- Publication Source
- Find A Tender Service
- Latest Notice
- https://www.find-tender.service.gov.uk/Notice/014694-2024
- Current Stage
- Award
- All Stages
- Award
Procurement Classification
- Notice Type
- Award Notice
- Procurement Type
- Standard
- Procurement Category
- Services
- Procurement Method
- Limited
- Procurement Method Details
- Award procedure without prior publication of a call for competition
- Tender Suitability
- Not specified
- Awardee Scale
- Large
Common Procurement Vocabulary (CPV)
- CPV Divisions
85 - Health and social work services
-
- CPV Codes
85121200 - Medical specialist services
Notice Value(s)
- Tender Value
- Not specified
- Lots Value
- Not specified
- Awards Value
- Not specified
- Contracts Value
- £617,001 £500K-£1M
Notice Dates
- Publication Date
- 8 May 20241 years ago
- Submission Deadline
- Not specified
- Future Notice Date
- Not specified
- Award Date
- 30 Apr 20241 years ago
- Contract Period
- Not specified - Not specified
- Recurrence
- Not specified
Notice Status
- Tender Status
- Complete
- Lots Status
- Not Specified
- Awards Status
- Active
- Contracts Status
- Active
Buyer & Supplier
Contracting Authority (Buyer)
- Main Buyer
- THE UNIVERSITY OF BIRMINGHAM
- Contact Name
- Kseniya Samsonik
- Contact Email
- k.samsonik@bham.ac.uk
- Contact Phone
- +44 1214146899
Buyer Location
- Locality
- BIRMINGHAM
- Postcode
- B15 2TT
- Post Town
- Birmingham
- Country
- England
-
- Major Region (ITL 1)
- TLG West Midlands (England)
- Basic Region (ITL 2)
- TLG3 West Midlands
- Small Region (ITL 3)
- TLG31 Birmingham
- Delivery Location
- Not specified
-
- Local Authority
- Birmingham
- Electoral Ward
- Edgbaston
- Westminster Constituency
- Birmingham Edgbaston
Further Information
Notice URLs
Open Contracting Data Standard (OCDS)
View full OCDS Record for this contracting process
The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts.
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