Official UK procurement notice
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/treatment for research and development, education/teaching and training
Authority: University of Sheffield (Education)·Consortium: 2 public authorities
What is being bought
Published requirement descriptionThe 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:-
www.sheffield.ac.uk/news/new-gene-therap… ↗
The UoS requires various bioreactors and complimentary/integrated equipment (sealer, welder etc), in order to undertake this co-ordinated work in parallel to 2 other UK sites (NHS Blood and Transplant (Bristol) and Kings College London working on identical methods and processes. To ensure the consistency of the science and comparability of the results, the same equipment needs to be purchased as the other two facilities.
CPV: Biomedical equipment · Installation services of laboratory equipment
The lotProcurement structure
single lot · no lot value publishedLot #1In order to assist with the tech transfer from Catapult the following items are being…Awarded
In order to assist with the tech transfer from Catapult the following items are being purchased 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 Biowelder
2 x Sartorius Biosealer
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.
As of 27/07/2022 The University of Sheffield has placed orders for the following equipment:-
a) 1 x Sartorius Biowelder and 1 x Sartorius Biosealer
b) 1 x Sartorius BIOSTAT® RM 20 / 50 (BIOSTAT® B - perfusion ready) and 1 x Sartorius Twin UniVessel 2 L STR + BIOSTAT® B
c) 1 x Sartorius Biostat STR 50
Procedure terms & legal framework
From the official record- 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
- 16 Dec 2021, 17:07 GMT
- Last source update
- 27 Jul 2022, 11:15 BST
- FTS notice number
2022/S 000-020442- Classification (CPV)
- Delivery area
- Official registry OCID
ocds-h6vhtk-03027fFind 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 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 GTIMX due by end Q4 2024.
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.
Notice history
1 event · 2 releases on Find a Tender- Buyer details updated27 Jul 2022, 11:15 BST
Commercial outcome & contract awards
Published awards, contracts and bid statistics, not a forecast| Awarded to | Value | Date | Status |
|---|---|---|---|
| Sartorius Stedim UK LtdSartorius Biosealer and Bioweler | £58,000 † | — | Awarded |
| Sartorius Stedim UK LtdBiostat STR 50L | £228,000 † | — | Awarded |
| Sartorius Stedim UK LtdBiostat RM 20/50L and Twin Univessel 2 L | £226,000 † | — | Awarded |
| Sartorius Stedim UK Ltd | £2,300,000 † | — | Awarded |
Contracts
Biostat RM 20/50L and Twin Univessel 2 L · Sartorius Stedim UK Ltd
- Signed
- 14 Jul 2022
- Value
- £226,000
- Status
- active
Biostat STR 50L · Sartorius Stedim UK Ltd
- Signed
- 11 Jul 2022
- Value
- £228,000
- Status
- active
Sartorius Biosealer and Bioweler · Sartorius Stedim UK Ltd
- Signed
- 31 May 2022
- Value
- £58,000
- Status
- active
Contract 031496-2021-1 · Sartorius Stedim UK Ltd
- Signed
- 16 Dec 2021
- Value
- £2,300,000
- Status
- active
Bid statistics published by the authority
| Bids | SME | VCSE | Valid bid range |
|---|---|---|---|
| 1bids | — | — | — |
Contracting authority & participating public bodies
2 public bodies on the noticeDispute resolution & review bodies
- High Court of England, Wales and Northern IrelandReview body
Bidders & participating suppliers
2 commercial parties on the notice- Sartoris Stedim UK LimitedAwarded supplier
- Sartorius Stedim UK LimitedAwarded supplier
Official documents & specifications
Official links; attachments are not copiedNo document links were published on the notice.