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Contract Award Notice

GMP Feasibility Study

  • First published: 03 December 2020
  • Last modified: 03 December 2020
  • Version: N/A
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To record your interest or obtain additional information or documents please find instructions within the Full Notice Text. (NOTE: Contract Award Notices and Prior Information Notices do not normally require a response)

Contents

Summary

OCID:
ocds-kuma6s-105067
Published by:
Cardiff University
Authority ID:
AA0258
Publication date:
03 December 2020
Deadline date:
-
Notice type:
Contract Award Notice
Has documents:
No
Has SPD:
No
Has Carbon Reduction Plan:
N/A

Abstract

The School of Pharmacy, Cardiff University, wishes to appoint a contractor to undertake a specialist evaluation and feasibility study of Cardiff University Redwood Building currently unlicenced Good Manufacturing Practice (GMP) suite for adaptation and recommissioning for alternative use. The successful Bidder will be required to conduct a feasibility study for change of use of an existing cleanroom for manufacture of GMP-compliant advanced therapies (cell and gene therapies). The existing cleanroom was built in 2010 according to MHRA specifications to enable small scale development of pharmaceutics, process optimization and product development. The unit is split into two areas, each with their own designated change facility: a pharmaceutical grade area and a grade B sterile production area. The 106m2 EU GMP Class B/ISO 14644-1 Class 5 floor space currently contains four double glove, rigid positive pressure Class A Isolators, a horizontal Laminar Air Flow Cabinet, and a negative pressure 4 glove hazardous products isolator. The unit also provides 45m2 of unclassified production space, with an adjoining preparation room, a microbiology facility with Class II safety cabinet and non-pharmaceutical autoclaves. Intended use: The facility is intended to be modified as a translational GMP Facility that will function as a versatile platform for developing clinically applicable cell and gene therapies for cancer, neurodegenerative and other diseases and for regenerative medicine products.

Full notice text

CONTRACT AWARD NOTICE – NATIONAL

SERVICES

1 Authority Details

1.1

Authority Name and Address


Cardiff University

Procurement Services, McKenzie House, 30-36 Newport Road,

Cardiff

CF24 0DE

UK

Julie Paynter, Senior Procurement Officer

+44 2920879648


http://www.cardiff.ac.uk/business/why-work-with-us/for-suppliers

2 Contract Details

2.1

Title

GMP Feasibility Study

2.2

Description of the contract

The School of Pharmacy, Cardiff University, wishes to appoint a contractor to undertake a specialist evaluation and feasibility study of Cardiff University Redwood Building currently unlicenced Good Manufacturing Practice (GMP) suite for adaptation and recommissioning for alternative use.

The successful Bidder will be required to conduct a feasibility study for change of use of an existing cleanroom for manufacture of GMP-compliant advanced therapies (cell and gene therapies).

The existing cleanroom was built in 2010 according to MHRA specifications to enable small scale development of pharmaceutics, process optimization and product development. The unit is split into two areas, each with their own designated change facility: a pharmaceutical grade area and a grade B sterile production area. The 106m2 EU GMP Class B/ISO 14644-1 Class 5 floor space currently contains four double glove, rigid positive pressure Class A Isolators, a horizontal Laminar Air Flow Cabinet, and a negative pressure 4 glove hazardous products isolator. The unit also provides 45m2 of unclassified production space, with an adjoining preparation room, a microbiology facility with Class II safety cabinet and non-pharmaceutical autoclaves.

Intended use:

The facility is intended to be modified as a translational GMP Facility that will function as a versatile platform for developing clinically applicable cell and gene therapies for cancer, neurodegenerative and other diseases and for regenerative medicine products.

2.3

Notice Coding and Classification

79314000 Feasibility study
1022 Cardiff and Vale of Glamorgan

2.4

Estimated Total Value

3 Procedure

3.1

Type of Procedure

Single stage

4 Award of Contract

4.1

Successful Bidders

4.1.1

Name and Address of successful supplier, contractor or service provider


CU.473.JP




Cube Cleantech

St John's Innovation Park, Cowley Road,

Cambridge

CB40WS

UK




www.cctech.eu

5 Other Information

5.1

Reference number attributed to the notice by the contracting authority

CU.473.JP

5.2

Date of Contract Award

 30-11-2020

5.3

Number of tenders received

3

5.4

Other Information

(WA Ref:106276)

5.5

Additional Documentation

N/a

5.6

Publication date of this notice:

 03-12-2020

Coding

Commodity categories

ID Title Parent category
79314000 Feasibility study Market research services

Delivery locations

ID Description
1022 Cardiff and Vale of Glamorgan

Alert region restrictions

The buyer has restricted the alert for this notice to suppliers based in the following regions.

ID Description
There are no alert restrictions for this notice.

Document family

Notice details
Publication date:
23 October 2020
Deadline date:
18 November 2020 00:00
Notice type:
Contract Notice
Authority name:
Cardiff University
Publication date:
03 December 2020
Notice type:
Contract Award Notice
Authority name:
Cardiff University

About the buyer

Main contact:
N/a
Admin contact:
N/a
Technical contact:
N/a
Other contact:
N/a

Further information

Date Details
No further information has been uploaded.

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