United Kingdom-SHEFFIELD: Equipment including Liquid Chromatography and protein/vector purification systems for the use in the manufacture of gene therapy drugs/treatments for research and development, education/teaching and training.

Type of document: Contract Notice
Country: United Kingdom
Publication Ref: (2022/S 000-000544/EN)
Nature of contract: Supply contract
Procedure: Negotiated without a call for competition
Type of bid required: Not applicable

Voluntary ex ante transparency notice
Supplies

Section I: Contracting authority
I.1) Name and addresses
Official name: UNIVERSITY OF SHEFFIELD
Postal address: Western Bank
Town: SHEFFIELD
Postal code: S102TN
Country: United Kingdom
Contact Person: Jamie Shaw
Telephone: +44 1142221516
Email: jamie.shaw@sheffield.ac.uk
Internet address(es):
Main address:

I.4) Type of the contracting authority
Body governed by public law
I.5) Main activity
Education

Section II: Object
II.1) Scope of the procurement
II.1.1) Title: Equipment including Liquid Chromatography and protein/vector purification systems for the use in the manufacture of gene therapy drugs/treatments for research and development, education/teaching and training.
II.1.2) Main CPV code: 38434540
II.1.3) Type of contract Supplies
II.1.4) Short Description:
The University of Sheffield (UoS) is establishing a new ‘Gene Therapy Innovation Manufacturing Centre’ (GTIMC) to advance scientific discoveries into life-changing treatments for patients with life threatening diseases. The Sheffield GTIMC will be one of three cutting edge hubs in the UK dedicated to advancing the clinical development of new genetic treatments. This facility is due to open in the Summer of 2022 and further details can be found at the following link:-

The UoS requires various Liquid Chromatography and protein/vector purification systems, in order to undertake this co-ordinated work in parallel to other UK site, NHS Blood and Transplant (Bristol), working on identical methods and processes. To ensure the consistency of the science and comparability of the process development and results, the same equipment needs to be purchased as the other hub at NHSBT. GTIMC and NHSBT Hubs will use the same manufacturing platform being tech transferred from Cell and Gene Therapy Catapult.
II.1.6) Information about lots
The contract is divided into lots: no
II.1.7) Total value of the procurement(excluding VAT)
Value:950000
Currency:GBP
II.2) Description
II.2.2)Additional CPV code(s)
Main CPV code: 51430000

II.2.3) Place of performance
Nuts code: Main site or place of performance:Gene Therapy Innovation and Manufacturing Centre, Faculty of Medicine Dentistry of Health, The University of Sheffield

II.2.4) Description of the procurement
In order to assist with the tech transfer from Catapult the following item is being purchased asap:
1 x ÄKTA Avant 150
Between 2022 and 2027 the following items may be purchased:-
2 x ÄKTA Avant 150
3 x AKTAPilot 600S
The above equipment will be used to furnish one research and development lab and two clean rooms.
Installation, commissioning, consumables, training and annual support/maintenance/calibration will be incorporated for between 3 and 5 years as part of the purchase.

II.2.5) Award criteria
II.2.11) Information about options
Options: no
II.2.13) Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds: no
II.2.14) Additional information:
Regulation 32 of PCR 2015 is being applied as in 32. (2) (b) (ii) and 32. (5) (a).
No contract will be entered into until after a 10 calendar day period from the submission of the VEAT notice date.

Section IV: Procedure
IV.1) Description
IV.1.1) Type of procedure
Negotiated procedure without prior publication(in accordance with Article 32 of Directive 2014/24/EU)
IV.1.8) Information about the Government Procurement Agreement(GPA)
The procurement is covered by the Government Procurement Agreement: yes
IV.2) Administrative information

Section V: Award of contract/concession
V.2) Award of contract/concession
V.2.1) Date of conclusion of the contract/concession award decision:2022-01-07
V.2.2) Information about tenders
V.2.3) Name and address of the contractor
Official name: Global Life Sciences Solutions Operations UK Ltd
Town: Sheffield
Country: United Kingdom
Nuts code:
The contractor is an SME: no

V.2.4) Information on value of the contract/lot/concession(excluding VAT)
for framework agreements – total maximum value for this lot
for contracts based on framework agreements, if required – value of contract(s) for this lot not included in
previous contract award notices

Section VI: Complementary informationVI.4) Procedures for review
VI.4.1) Review body
Official name: High Court of England, Wales and Northern Ireland
Town: London
Country: United Kingdom

VI.5) Date of dispatch of this notice:
2022-01-07

Justification for the award of the contract without prior publication of a call for
competition in the Official Journal of the European Union
1.Justification for the choice of the negotiated procedure without prior publication of a call for competition in accordance with Article
32 of Directive 2014/24/EU
The products involved are manufactured purely for the purpose of research , experiment, study or development under the conditions stated
in the directive(for supplies only)
The works, supplies or services can be provided only by a particular economic operator for the following reason:
absence of competition for technical reasons

3.Explanation
Please explain in a clear and comprehensive manner why the award of the contract without prior publication in the Official Journal of the European Union
is lawful, by stating the relevant facts and, as appropriate, the conclusions of law in accordance with the directive:
The University of Sheffield signed an agreement with Cell and Gene Therapy Catapult (CGT Catapult) to tech transfer the Catapult AAV (Adeno-Associated Virus) manufacturing platform to Gene Therapy Innovation and Manufacturing Centre’ (GTIMC). This task is one of the milestones under the funding award supporting the establishment of the GTIMC in Sheffield. The milestone must be completed within 12 months of the start of the GTIMC Project, i.e. by end July 2022. Any delay in the tech transfer will also impact on the milestone related to MHRA accreditation of GTIMC due by end Q4 2022.
Using exactly the same equipment as the set up at Cell and Gene Therapy Catapult facilities will minimise delays and reduce time/avoid the need for optimisation of manufacturing protocols at GTIMC and allow us timely and within budget achievement of tech transfer milestones, optimisation using non generic equipment may introduce inconsistent results and invalidate the process which as a result would delay process, characterisation and final production processes.
The GTIMC and University of Sheffield will jointly acquire a technology license from CGT Catapult to be able to use their AAV manufacturing platform. This platform was established and optimised based on the processes developed using the proposed list of equipment.
The list of equipment (as set out herein) and the estimated timescales we plan to purchase was included in our proposal to the MRC/LifeArc to secure funding for the establishment of GTIMC in Sheffield. The subsequent Grant Offer includes the specific brands/models of equipment set out herein.
A single source is therefore proposed to formalise the solution provided by Global Life Sciences Solutions Operations UK Ltd (Cytiva) for the following reasons: –
This equipment has been identified and is currently used by CGT Catapult and therefore to not use the same equipment would invalidate the Tech Transfer processes and agreements.
Furthermore, this specific equipment and supplier was identified by CGT Catapult as the optimum type to produce the results and treatments for the better advancement of the process, deviation from this would require significant lengthy additional optimisation which would significantly delay the process and miss funding milestones and therefore minimise delays and reduce time/avoid the need for optimisation of manufacturing protocols at GTIMC and allow us timely and within budget achievement of tech transfer milestones, optimisation using different equipment may introduce inconsistent results and invalidate the process which as a result would delay process, characterisation and final production processes.
Finally, the equipment set out herein will purely for the purpose of research, experiment, study or development within the University and no commercial licence will be held during the lifespan of this equipment. The prime functions of the GTIMC hub is to accelerate translational of gene therapy programs and clinical trials for rare monogenic diseases.
To increase the U.K. capacity for GMP clinical vector manufacturing using the catapult process to allow for expansion of U.K. skills and training within the GTIMC space and increase partnerships with other academia which will create a fertile ecosystem for innovation and research excellence in this field across academia.