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

Concepts

• biomedical equipment
• sheffield
• uos
• gene therapy innovation manufacturing centre
• hydrogen peroxide vapour
• laboratory equipment
• decontamination equipment
• aseptic workstation
• decontamination capability
• hpv

Location

Gene Therapy Innovation and Manufacturing Centre, Faculty of Medicine Dentistry of Health, The University of Sheffield

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 opened in the Summer of 2022 and further details can be found at the following link: - https://www.sheffield.ac.uk/news/new-gene-therapy-innovation-centre-advance-scie... The UoS requires a Modular Isolator with integrated Hydrogen Peroxide Vapour (HPV) decontamination capability 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.

Total Quantity or Scope

In order to assist with the tech transfer from Catapult the following item is being purchased asap: 1 x Bioquell QUBE Modular Aseptic Workstation with integrated Hydrogen Peroxide Vapour (HPV) decontamination and 1 x Bioquell QUBE System - M-35 The above equipment will be used to furnish two clean rooms. Installation, commissioning, consumables and training

Award Detail

Award Criteria

CPV Codes

• 38434540 - Biomedical equipment
• 51430000 - Installation services of laboratory equipment

Legal 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.

Other Information

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