Section one: Contracting authority
one.1) Name and addresses
University Of Edinburgh
Charles Stewart House, 9-16 Chambers Street
Edinburgh
EH1 1HT
Telephone
+44 1316502759
Country
United Kingdom
NUTS code
UKM75 - Edinburgh, City of
Internet address(es)
Main address
Buyer's address
https://www.publiccontractsscotland.gov.uk/search/Search_AuthProfile.aspx?ID=AA00107
one.2) Information about joint procurement
The contract is awarded by a central purchasing body
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
Batch manufacture of high titer/titre GMP (U.S.A.) compliant lentiviral vector for FDA approval
Reference number
EC1057
two.1.2) Main CPV code
- 33600000 - Pharmaceutical products
two.1.3) Type of contract
Supplies
two.1.4) Short description
We are planning a phase I/II clinical trial to treat a rare genetic disease that causes
progressive dementia in children. Our therapy will use autologous CD34+ haematopoietic
stem progenitor cells (HSPCs) which are modified ex vivo with LVV to express
supraphysiologic levels of a secreted enzyme.
In order to progress this therapy, we require a high titre LVV produced to good
manufacturing practice (GMP) standard. The supplier must have extensive previous
experience manufacturing LVVs to this specification which have achieved regulatory
approval for phase I/II clinical trials, ideally for use in human CD34+ HSPC transduction.
The QC defined must be performed in compliance with FDA regulations. The product of
the initial delivery will be delivered directly to the University of California, LA, USA.
Note that throughout the document the British spelling ‘Titre’ has been used; this is
analogous to the American English term ‘Titer’ and the spellings may be used
interchangeably.
The University anticipates initially awarding for;
- Manufacture of concentrated lentiviral vector (LVV) from a 30L viral harvest
- Such award to include any warranties on quality, product replacement (for spoilage),
transport, and other supplier project costs such as (but not limited to) quality control
testing and audit.
The cost estimate of the procurement reflects the anticipated cost of the initial
requirement plus contingency, for (for example but not limited to), 1. Scope extension, 2.
Additional ad-hoc delivery to support further trials.
The time frame of the agreement – 3 years, reflects an initial delivery period expected to
be no longer than 12 months post signature, and the option to buy additional deliveries for
two years thereafter. The University may award additional deliveries to the awarded
supplier via the Negotiated Procedure Without Prior Call for Competition.
For transparency we have a budget appetite of approximately USD560k for the delivery of
the initial services. We may review this estimate from time to time.
Having posted this notice we reserve the right to repost any subsequent notice (including
if the ultimate procurement procedure is re-run) under reduced timescales as set out in
the regulations.
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: 586,904 USD
two.2) Description
two.2.3) Place of performance
NUTS codes
- US - United States
- UKM75 - Edinburgh, City of
Main site or place of performance
Product is to be delivered to University of California, Los Angeles, U.S.A.
Contracting party University of Edinburgh is in Edinburgh, Scotland, UK
two.2.4) Description of the procurement
See procurement documentation for all un-abridged description.
DEFINITIONS
FDA is the U.S Food and Drug Administration (FDA); the regulator for new clinical drugs
GMP means ‘Good Manufacturing Practice’; U.S.A.
IND is an “Investigational New Drug Application”; a request to the FDA to be permitted to
administer a new prototype drug on human patients for research purposes
Lentiviral vector (LVV) is a type of virus (retrovirus) that inserts its DNA into the cells of
the organism/person it infects.
Plasmid is a small DNA molecule which stores non-chromosomal DNA.
Must-have capabilities
- Able to produce a 30L harvest of unconcentrated LVV-containing supernatant following
transduction of 293T cells from a certified Master Cell Bank with genome and packaging
plasmids supplied by the University
- Able to concentrate this supernatant by a factor of approx. 100-200x to produce a
concentrated high titre LVV
- The supplier must have extensive prior experience of such manufacture and have
achieved numerous regulatory approvals for use of their LVV products in phase I/II clinical
trials. This is critical to ensure there is confidence that the supplier product will be
acceptable and well-received for regulatory approval.
o 10 years prior experience of manufacturing GMP-compliant LVV products
o Achieved minimum of 50 prior regulatory approvals (ideally FDA) of GMP-compliant
LVV products
- Supplied should follow all relevant legislation applicable to this engagement including in
their location/s of manufacture, and the State of California, USA
- The supplier should demonstrate a manufacturing process which is compliant with GMP
and that gives high confidence of their ability to deliver a high quality, compliant, product.
- For the purposes of greater transparency, collaboration and regulatory traceability and
accountability we require a direct relationship with the manufacturing entity/lead and
therefore bids proposed by an entity acting solely as a reseller/distributor will unfortunately
not be acceptable for this requirement. It is our expectation that the bidder undertakes the
manufacturing; however other functions like Quality Control may be undertaken by
subcontractors providing that the bidder takes full ultimate responsibility for delivery of the
contract.
- The supplier should demonstrate a reasonable and practicable solution for logistical
delivery of the product.
- For transparency we have a budget appetite of approximately USD560k for the delivery
of the initial services. We may review this estimate from time to time.
Desirable criteria
- It is desirable that the supplier can complete end to end delivery of initial requirement
(including manufacture, quality control and regulatory pack preparation), within 12 months
or faster from contract signature. Fast delivery times are desirable for the project.
- It is desirable that the supplier takes full accountability for the transport of the product
from the site of manufacture to UCLA.
Quality control (‘QC’);
This will require comprehensive GMP compliance QC to be performed:
Supplier will be required to provide details of the GMP-compliant manufacturing process
Intellectual property
For avoidance of doubt; the intellectual property (“IP”) the University provides during the
project in relation to the product specification will remain vested in the University and its
licensors and nothing in the awarded contract shall constitute granting a license, creating
a joint endeavour, creating joint IP, or otherwise constituting a license or transfer of IP to
the Supplier, that would entitle the Supplier to take any action utilising that IP beyond the
bounds of the Services which will be agreed between the University and Supplier
pursuant of this tender.
two.2.5) Award criteria
Quality criterion - Name: Suitability to fulfil requirement / Weighting: 50
Cost criterion - Name: Total cost / Weighting: 50
two.2.11) Information about options
Options: Yes
Description of options
The time frame of the agreement – 3 years, reflects an initial delivery period expected to
be no longer than 12 months post signature, and the option to buy additional deliveries for
two years thereafter. The University may award additional deliveries to the awarded
supplier via the Negotiated Procedure Without Prior Call for Competition.
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Competitive procedure with negotiation
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: 2025/S 000-044163
Section five. Award of contract
Contract No
EC1057
A contract/lot is awarded: Yes
five.2) Award of contract
five.2.1) Date of conclusion of the contract
7 November 2025
five.2.2) Information about tenders
Number of tenders received: 1
Number of tenders received from SMEs: 0
Number of tenders received from tenderers from other EU Member States: 0
Number of tenders received from tenderers from non-EU Member States: 1
Number of tenders received by electronic means: 1
The contract has been awarded to a group of economic operators: No
five.2.3) Name and address of the contractor
Indiana University
1024 East 3rd Street, Room 132
Bloomington
47405
Telephone
+001 3172786518
Country
United States
NUTS code
- US - United States
The contractor is an SME
No
five.2.4) Information on value of contract/lot (excluding VAT)
Total value of the contract/lot: 586,904 USD
Section six. Complementary information
six.3) Additional information
(SC Ref:817966)
six.4) Procedures for review
six.4.1) Review body
Edinburgh Sheriff Court
Edinburgh
Country
United Kingdom