CONTRACT NOTICE – NATIONAL

1 Authority Details

1.1

Authority Name and Address

1.2

Address from which documentation may be obtained

As in 1.1

1.3

Completed documents must be returned to:

As in 1.1

2 Contract Details

2.1

Title

GMP Feasibility Study

2.2

Description of the goods or services required

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.

NOTE: To register your interest in this notice and obtain any additional information please visit the Sell2Wales Web Site at https://www.sell2wales.gov.wales/Search/Search_Switch.aspx?ID=105067.

2.3

Notice Coding and Classification

2.4

Total quantity or scope of tender

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.

3 Conditions for Participation

3.1

Minimum standards and qualification required

As stated in the Invitation to Tender (ITT) documents.

4 Administrative Information

4.1

Type of Procedure

Single stage

4.2

Reference number attributed to the notice by the contracting authority

CU.473.JP

4.3

Time Limits

4.5

Language or languages in which tenders or requests to participate can be drawn up

Welsh

4.6

Tender Submission Postbox

5 Other Information

5.1

Additional Information

All tender costs and liabilities incurred by bidders shall be the sole responsibility of bidders.

The University reserves the right to award the contract in whole or in part.

The University reserves the right to annul the tendering process and not award any contract.

All documents to be priced in GBP and all payments made in GBP.

All documents to be priced in GBP excluding VAT.

(WA Ref:105067)

5.2

Additional Documentation

5.3

Publication date of this notice