Section one: Contracting authority/entity
one.1) Name and addresses
THE UNIVERSITY OF BIRMINGHAM
Edgbaston
BIRMINGHAM
B152TT
Contact
Kseniya Samsonik
Telephone
+44 1214146899
Country
United Kingdom
Region code
UKG31 - Birmingham
Companies House
RC000645
Internet address(es)
Main address
one.4) Type of the contracting authority
Body governed by public law
one.5) Main activity
Education
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
ACT2 Project
two.1.2) Main CPV code
- 85121200 - Medical specialist services
two.1.3) Type of contract
Services
two.1.4) Short 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.
two.1.6) Information about lots
This contract is divided into lots: No
two.1.7) Total value of the procurement (excluding VAT)
Value excluding VAT: £617,001.66
two.2) Description
two.2.3) Place of performance
NUTS codes
- UK - United Kingdom
two.2.4) Description of the procurement
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.
two.2.11) Information about options
Options: No
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Award of a contract without prior publication of a call for competition in the cases listed below
- The procurement falls outside the scope of application of the regulations
Explanation:
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.
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes
Section five. Award of contract/concession
A contract/lot is awarded: Yes
five.2) Award of contract/concession
five.2.1) Date of conclusion of the contract
1 May 2024
five.2.2) Information about tenders
The contract has been awarded to a group of economic operators: No
five.2.3) Name and address of the contractor/concessionaire
Robert Jones and Agnes Hunt Orthopaedic Hospital
Arthritis Research Centre, Rjah Hospital
Oswestry
SY10 7AG
Country
United Kingdom
NUTS code
- UK - United Kingdom
Companies House
02992437
The contractor/concessionaire is an SME
No
five.2.4) Information on value of contract/lot/concession (excluding VAT)
Initial estimated total value of the contract/lot/concession: £617,001.66
Total value of the contract/lot/concession: £617,001.66
Section six. Complementary information
six.4) Procedures for review
six.4.1) Review body
The University of Birmingham
Birmingham
Country
United Kingdom