---
title: "Consultancy Services relating to design, validation and Qualification of Clean Rooms within Gene Therapy Innovation and Manufacturing Centre"
ocid: "ocds-b5fd17-c0fb6c4f-b039-4985-8448-2c56e8dc8e4d"
canonical_url: "https://d3tenders.com/contract/?ocid=ocds-b5fd17-c0fb6c4f-b039-4985-8448-2c56e8dc8e4d"
markdown_url: "https://d3tenders.com/contract/ocds-b5fd17-c0fb6c4f-b039-4985-8448-2c56e8dc8e4d.md"
json_url: "https://d3tenders.com/contract/ocds-b5fd17-c0fb6c4f-b039-4985-8448-2c56e8dc8e4d.json"
source: "Contracts Finder"
current_stage: "Award"
buyer: "UNIVERSITY OF SHEFFIELD"
published: "2022-05-27"
---

# Consultancy Services relating to design, validation and Qualification of Clean Rooms within Gene Therapy Innovation and Manufacturing Centre

Buyer: UNIVERSITY OF SHEFFIELD  
Current stage: Award  
OCID: ocds-b5fd17-c0fb6c4f-b039-4985-8448-2c56e8dc8e4d

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## Summary

The University of Sheffield is seeking consultancy services for the design, validation, and qualification of clean rooms within its Gene Therapy Innovation and Manufacturing Centre, located in Yorkshire and the Humber, England. The procurement stage is currently at the award phase, with a total contract value of £280,124. The contract period is set from 16 February 2022 to 31 January 2023, following a negotiated procedure without prior publication. Notably, the service is required to commence early in February 2022 to meet aggressive project timelines, with a completion deadline for the construction set for July 2022.

This tender presents a significant opportunity for SMEs, particularly those with a strong background in construction consultancy services, clean room manufacturing, or experience working within the regulatory framework of the MHRA in sectors such as cell and gene therapy. Businesses that have demonstrated recent engagement in these areas, especially related to Covid-19 vaccine responses, will find themselves well-positioned to compete. The requirement for regular site attendance and collaboration throughout the construction and licensing process underscores the need for firms that can quickly adapt and meet demanding timelines in a highly specialised field.

## Notice

Services are required for a number of tasks during the Qualification and Validation stages of the build completion of the Research and Development facilities including all Quality Control, Clean Room areas in grades C and grade D environments in addition to all process areas across the site and supporting site operations such as major infrastructure and support services such as logistics in addition to other areas. These works are to cover the following areas / requirements:- Qualification Requirement Matrix prepared to track Validation Lifecycle and to support MHRA Audit. Used on previous MHRA audits and proved effective; Validation Assessment, User Requirement Specifications, Validation Plan, Design Document Reviews; Vendor Document Reviews, Factory Acceptance Tests Site Acceptance Tests (Commissioning); COTS Installation/Operational Qualification Protocol, Installation Qualification Protocol; Thermal Mapping Protocol (Empty and Loaded), Operational Qualification Protocol; Performance Qualification Protocol, Validation Summary Reports. It is envisage that the majority of documentation preparation will be carried out remotely from the new build site however close working relationships will be required with attendance at site meetings for all aspects of the build and clean room fit outs will be required therefore an estimate of 50% site attendance is anticipated. It will be a requirement that the provider will regularly visit site throughout the construction period to ensure that the build is being documented to a suitable standard to allow for information leveraging into qualification. These visits will also be to ensure that the MHRA are suitably informed throughout all stages of the construction period. Attendance by the provider and being that professional capacity for all engagement with the MHRA will be a major requirement and throughout the Licence application process and to assist the client in this application process through to successfully licence being granted. Major recent experience is therefore a pre-request in interaction with the MHRA in the field of both Cell and Gene Therapy, Clean Room Manufacturing, Covid-19 Vaccine Response and recent demonstrated deployment / experience within Cell and Gene Therapy is of the highest importance. The project has extremely aggressive timelines with build construction due for completion in July 2022 and therefore standing up of this service will be required to be in place during the early stages of February 2022. The intention to award a contract as a 'Negotiated procedure without a prior call for competition' was previously published as a Voluntary ex ante transparency notice (reference: 2022/S 000-002231) on 25 January 2022. Regulation 32 of PCR 2015 was applied as in 32. (2) (b) (ii). This Award Notice is for Phase 1 of the project and Phase 2 (for potential service) up to an overall total of PS370,000.

## Key Details

| Field | Value |
| --- | --- |
| Publication source | Contracts Finder |
| Latest notice | https://www.contractsfinder.service.gov.uk/Notice/9c3aa62b-780b-4a5b-bfd6-a9201bb9bec4 |
| Notice type | Award Notice |
| Procurement type | Standard |
| Procurement category | Services |
| Procurement method | Limited |
| Procurement method details | Negotiated procedure without prior publication (above threshold) |
| Tender suitability | SME |
| Awardee scale | SME |
| All stages | Award |

## Dates

| Field | Value |
| --- | --- |
| Publication date | 27 May 2022 |
| Submission deadline | 4 Feb 2022 |
| Future notice date | Not specified |
| Award date | 16 Jan 2022 |
| Contract period | 23 Feb 2022 - 31 Jan 2023 |
| Recurrence | Not specified |

## Values

| Field | Value |
| --- | --- |
| Tender value | £280,124 |
| Lots value | Not specified |
| Awards value | £280,124 |
| Contracts value | Not specified |

## Status

| Field | Value |
| --- | --- |
| Tender status | Complete |
| Lots status | Not specified |
| Awards status | Active |
| Contracts status | Not specified |

## Buyer

| Field | Value |
| --- | --- |
| Main buyer | UNIVERSITY OF SHEFFIELD |
| Locality | SHEFFIELD |
| Post town | Sheffield |
| Postcode | S10 2TN |
| Country | England |
| ITL 1 | TLE Yorkshire and The Humber |
| ITL 2 | TLE3 South Yorkshire |
| ITL 3 | TLE32 Sheffield |
| Local authority | Sheffield |
| Electoral ward | Broomhill and Sharrow Vale |
| Westminster constituency | Sheffield Central |
| Delivery location | TLE Yorkshire and The Humber |

## Supplier

| Field | Value |
| --- | --- |
| Number of suppliers | 1 |
| Supplier names | COMPLETE TECHNICAL SOLUTIONS |

## CPV Codes

### Divisions

- 71 - Architectural, construction, engineering and inspection services

### Codes

- 71530000 - Construction consultancy services

## Release History

- 27 May 2022 at 11:48 - Award - Award Notice - https://www.contractsfinder.service.gov.uk/Notice/9c3aa62b-780b-4a5b-bfd6-a9201bb9bec4

## Documents

- https://www.contractsfinder.service.gov.uk/Notice/9c3aa62b-780b-4a5b-bfd6-a9201bb9bec4
  27th May 2022 - Awarded contract notice on Contracts Finder

## Provenance

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