Gene Therapy Innovation Manufacturing Centre

The project aimed to deliver a new facility for the Gene Therapy Innovation and Manufacturing Centre (GTIMC) in Sheffield, built to meet MHRA (Medicines and Healthcare products Regulatory Agency) standards. However, achieving MHRA accreditation fell outside the formal scope of the contract. In addition, the scheme required extensive engagement with a diverse range of academic stakeholders, each with specific technical requirements and expectations.

G&T provided Project Management and Principal Designer & CDM Consultancy services, supporting the project by facilitating complex stakeholder engagement throughout the design and construction phases. Regular meetings were coordinated with specialist manufacturers and academic representatives to ensure alignment of objectives and technical standards. A dedicated MHRA specialist was appointed during RIBA Stages 2 to 4 to oversee the design development and ensure compliance with regulatory expectations, while also monitoring the construction works on site.

Through proactive stakeholder management and the involvement of a regulatory expert, the project team successfully navigated the challenges of delivering a facility designed to MHRA standards. G&T’s structured approach helped to ensure that the facility met its operational needs and was well positioned for future MHRA accreditation, despite it being outside the original contract remit.