Aseptic Workstation with integrated Hydrogen Peroxide Vapour (HPV) decontamination equipment for the use in the manufacture of gene therapy drugs/treatments for research and development, education/teaching and training.

CPV: Biomedical equipment · Installation services of laboratory equipment

Procedure method

Award procedure without prior publication of a call for competition

Legal basis

CELEX · 32014L0024 Public Contracts Regulations 2015 (Directive 2014/24/EU)

Procurement category

Goods

Notice status

Awarded without competition

Procurement threshold

Unspecified in notice

Regulatory regime

Standard

Commercial structure

Stand-alone contract (no framework)

Competition type

Direct award (no call for competition)

GPA / WTO covered

Yes (GPA)

Recurring procurement

Unspecified in notice

First published

20 Jan 2023, 10:10 GMT

Last source update

28 Feb 2023, 15:45 GMT

FTS notice number

2023/S 000-005893

Classification (CPV)

Biomedical equipmentInstallation services of laboratory equipment

Delivery area

Yorkshire & Humber (UKE32)

Official registry OCID

ocds-h6vhtk-039927 Find a Tender

Why no open competition

The products involved are manufactured purely for the purpose of research, experiment, study or development under the conditions stated in the directive; The works, supplies or services can be provided only by a particular economic operator due to absence of competition for technical reasons

Published justification

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 asap. Any delay in the tech transfer will also impact on the milestone related to MHRA accreditation of GTIMC due by end Q4 2023.

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.

A single source is therefore proposed to formalise the solution provided by ECOLAB LTD 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.

• ECOLAB LTDAwarded supplierGB-COH: 00649192 Northwich, North West

No document links were published on the notice.