Section one: Contracting authority
one.1) Name and addresses
UNIVERSITY OF SHEFFIELD
Western Bank
SHEFFIELD
S102TN
Contact
Jamie Shaw
Telephone
+44 1142221516
Country
United Kingdom
Region code
UKE32 - Sheffield
UK Register of Learning Providers (UKPRN number)
UKPRN 10007157
Internet address(es)
Main address
one.4) Type of the contracting authority
Body governed by public law
one.5) Main activity
Education
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
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
two.1.2) Main CPV code
- 38434540 - Biomedical equipment
two.1.3) Type of contract
Supplies
two.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 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.
two.1.6) Information about lots
This contract is divided into lots: No
two.1.7) Total value of the procurement (excluding VAT)
Value excluding VAT: £2,300,000
two.2) Description
two.2.2) Additional CPV code(s)
- 51430000 - Installation services of laboratory equipment
two.2.3) Place of performance
NUTS codes
- UKE32 - Sheffield
Main site or place of performance
Gene Therapy Innovation Manufacturing Centre, Faculty of Medicine Dentistry of Health, The University of Sheffield
two.2.4) Description of the procurement
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.
two.2.5) Award criteria
Price
two.2.11) Information about options
Options: No
two.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.
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
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Award of a contract without prior publication of a call for competition in the cases listed below
- The products involved are manufactured purely for the purpose of research, experiment, study or development
- The services can be provided only by a particular economic operator for the following reason:
- absence of competition for technical reasons
Explanation:
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.
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes
four.2) Administrative information
four.2.1) Previous publication concerning this procedure
Notice number: 2021/S 000-031496
Section five. Award of contract
Title
Sartorius Biosealer and Bioweler
A contract/lot is awarded: Yes
five.2) Award of contract
five.2.1) Date of conclusion of the contract
31 May 2022
five.2.2) Information about tenders
Number of tenders received: 1
The contract has been awarded to a group of economic operators: No
five.2.3) Name and address of the contractor
Sartorius Stedim UK Limited
Epsom
Country
United Kingdom
NUTS code
- UKJ2 - Surrey, East and West Sussex
Companies House
06026124
The contractor is an SME
No
five.2.4) Information on value of contract/lot (excluding VAT)
Total value of the contract/lot: £58,000
Section five. Award of contract
Title
Biostat STR 50L
A contract/lot is awarded: Yes
five.2) Award of contract
five.2.1) Date of conclusion of the contract
11 July 2022
five.2.2) Information about tenders
Number of tenders received: 1
The contract has been awarded to a group of economic operators: No
five.2.3) Name and address of the contractor
Sartorius Stedim UK Limited
Epsom
Country
United Kingdom
NUTS code
- UKJ2 - Surrey, East and West Sussex
Companies House
06026124
The contractor is an SME
No
five.2.4) Information on value of contract/lot (excluding VAT)
Total value of the contract/lot: £228,000
Section five. Award of contract
Title
Biostat RM 20/50L and Twin Univessel 2 L
A contract/lot is awarded: Yes
five.2) Award of contract
five.2.1) Date of conclusion of the contract
14 July 2022
five.2.2) Information about tenders
Number of tenders received: 1
The contract has been awarded to a group of economic operators: No
five.2.3) Name and address of the contractor
Sartoris Stedim UK Limited
Epsom
Country
United Kingdom
NUTS code
- UKJ2 - Surrey, East and West Sussex
Companies House
06026124
The contractor is an SME
No
five.2.4) Information on value of contract/lot (excluding VAT)
Total value of the contract/lot: £226,000
Section six. Complementary information
six.4) Procedures for review
six.4.1) Review body
High Court of England, Wales and Northern Ireland
London
Country
United Kingdom