Equipment including single use bioreactors, biosealers, biowelders, benchtop controllers for stirred and rocking motion systems plus Single Use Centrifugal systems for the use in the manufacture of gene therapy drugs/treatments for research and development, education/teaching and training

Concepts

• biomedical equipment
• sheffield
• uos
• single use bioreactors
• laboratory equipment
• sartorius biowelder
• motion systems
• single use
• various bioreactors
• benchtop controllers

Location

Gene Therapy Innovation and Manufacturing Centre, Faculty of Medicine, Dentistry and 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 is due to open 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 various bioreactors and complimentary/integrated equipment (sealer, welder etc), 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 items are to be purchased asap: 1 x Sartorius Biowelder 1 x Sartorius Biosealer 1 x Sartorius BIOSTAT® RM 20 / 50 (BIOSTAT® B - perfusion ready) 1 x Sartorius Twin UniVessel 2 L STR + BIOSTAT® B Between 2022 and 2027 the following items may be purchased:- 2 x Sartorius Biowelders 2 x Sartorius Biosealers 2 x Sartorius BIOSTAT® RM 20 / 50 (BIOSTAT® B - perfusion ready) 2 x Sartorius Twin UniVessel 2 L STR + BIOSTAT® B 3 x Sartorius Biostat STR 50 3 x Sartorius kSep 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. 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.

Award Detail

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 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 Sartorius Stedim UK Limited 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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