Award

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

UNIVERSITY OF SHEFFIELD

This public procurement record has 1 release in its history.

Award

27 May 2022 at 11:48

Award Notice
Summary of the contracting process

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.

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Notice Information

Notice Title

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

Notice Description

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.

Notice Details

Publication & Lifecycle

Open Contracting ID
ocds-b5fd17-c0fb6c4f-b039-4985-8448-2c56e8dc8e4d
Publication Source
Contracts Finder
Latest Notice
https://www.contractsfinder.service.gov.uk/Notice/9c3aa62b-780b-4a5b-bfd6-a9201bb9bec4
Current Stage
Award
All Stages
Award

Procurement Classification

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

Common Procurement Vocabulary (CPV)

CPV Divisions

71 - Architectural, construction, engineering and inspection services

CPV Codes

71530000 - Construction consultancy services

Notice Value(s)

Tender Value
£280,124 £100K-£500K
Lots Value
Not specified
Awards Value
£280,124 £100K-£500K
Contracts Value
Not specified

Notice Dates

Publication Date
27 May 20223 years ago
Submission Deadline
4 Feb 2022Expired
Future Notice Date
Not specified
Award Date
16 Jan 20224 years ago
Contract Period
23 Feb 2022 - 31 Jan 2023 6-12 months
Recurrence
Not specified

Notice Status

Tender Status
Complete
Lots Status
Not Specified
Awards Status
Active
Contracts Status
Not Specified

Buyer & Supplier

Contracting Authority (Buyer)

Main Buyer
UNIVERSITY OF SHEFFIELD
Contact Name
Jamie Shaw
Contact Email
jamie.shaw@sheffield.ac.uk
Contact Phone
01142221516

Buyer Location

Locality
SHEFFIELD
Postcode
S10 2TN
Post Town
Sheffield
Country
England
Major Region (ITL 1)
TLE Yorkshire and The Humber
Basic Region (ITL 2)
TLE3 South Yorkshire
Small Region (ITL 3)
TLE32 Sheffield
Delivery Location
TLE Yorkshire and The Humber
Local Authority
Sheffield
Electoral Ward
Broomhill and Sharrow Vale
Westminster Constituency
Sheffield Central

Supplier Information

Number of Suppliers
1
Supplier Name

COMPLETE TECHNICAL SOLUTIONS

Further Information

Notice Documents

Open Contracting Data Standard (OCDS)

View full OCDS Record for this contracting process

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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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