ACT2 Study
Overview
Summary, notice description and lot information
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.
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.
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The contract period is one year.
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