Section one: Contracting authority
one.1) Name and addresses
University of Exeter
Northcote House
Exeter
EX4 4QH
Contact
Jodie Underhay
Country
United Kingdom
NUTS code
UKK4 - Devon
National registration number
RC000653
Internet address(es)
Main address
Buyer's address
https://uk.eu-supply.com/ctm/Company/CompanyInformation/Index/53042
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
Provision of Fasudil Hydrochloride Capsules
Reference number
UOE/2021/046/JU
two.1.2) Main CPV code
- 33000000 - Medical equipments, pharmaceuticals and personal care products
two.1.3) Type of contract
Supplies
two.1.4) Short description
The University of Exeter requires an end-to-end solution for Fasudil Hydrochloride Capsules. The product will be used as clinical supply for a Phase IIa study. The clinical trial will likely be conducted in the USA and/or Europe (United Kingdom and Norway), therefore all formulation components and finished product must meet the regulatory requirements of USP/EP/BP and any required Norwegian pharmacopeia standards. The supplier must also comply with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) and ensure that all supplies are released for clinical use by a duly certified Quality Person (QP).
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: £815,555
two.2) Description
two.2.2) Additional CPV code(s)
- 33000000 - Medical equipments, pharmaceuticals and personal care products
two.2.3) Place of performance
NUTS codes
- UKK4 - Devon
two.2.4) Description of the procurement
The University of Exeter requires an end-to-end solution for Fasudil Hydrochloride Capsules. The product will be used as clinical supply for a Phase IIa study. The clinical trial will likely be conducted in the USA and/or Europe (United Kingdom and Norway), therefore all formulation components and finished product must meet the regulatory requirements of USP/EP/BP and any required Norwegian pharmacopeia standards. The supplier must also comply with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) and ensure that all supplies are released for clinical use by a duly certified Quality Person (QP).
The supplier will undertake an evaluation of 3rd party suppliers for the procurement of the Drug Substance (DS) Fasudil Hydrochloride. It is anticipated that approximately 8.5kg of DS will be required for use in Drug Product development and manufacturing activities. This includes approximately 1kg DS for non-GMP activities and 7.5kg DS for GMP activities related to the project.
The supplier will perform development activities in order to establish suitable capsule formulations for 20mg and 40mg active dose strengths and matching placebo. These development activities will include the manufacture of up to six development batches at a batch size of approximately 750g -1.5kg. The lead and back-up formulations will be subjected to a short-term stability evaluation. The purpose of this effort is to manufacture sufficient supplies of prototypes to illustrate the likely process for clinical supply, and to prepare samples for accelerated stability testing so that suitable formulations of active and placebo tablets can be identified.
To fulfil clinical supply, the CTM active and placebo batches will be manufactured in three separate campaigns.
First Campaign:
one CTM Placebo batch at approximately 43,000 units
one CTM Active 20mg dose strength batch at 6,000 units
one CTM Active 40mg strength batch at approximately 40,000 units
Second campaign:
one CTM Placebo batch at approximately 43,000 units
one CTM Active batch at approximately 40,000 units
Third campaign:
one CTM Placebo batch at approximately 43,000 units
one CTM Active batch at approximately 40,000 units
Each CTM batch will be bulk packaged, labelled (in English and Norwegian) and shipped to enable delivery of the final QP released batches to the locations requested by Client (anticipated to be in the UK and Norway, 3 or 4 sites in total). The supplier will be responsible for any customs clearance required. The supplier will be required to provide all necessary supporting services including, but not limited to, sourcing materials and the active pharmaceutical ingredient/drug substance, production, storage, labelling, packaging, quality control, qualified person release, packing, transport, loading/unloading, import/export, delivery and waste disposal.
two.2.5) Award criteria
Price
two.2.11) Information about options
Options: No
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
Open procedure
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 000-016582
Section five. Award of contract
Contract No
1
Title
Provision of Fasudil Hydrochloride Capsules
A contract/lot is awarded: Yes
five.2) Award of contract
five.2.1) Date of conclusion of the contract
8 November 2021
five.2.2) Information about tenders
Number of tenders received: 4
Number of tenders received by electronic means: 4
The contract has been awarded to a group of economic operators: No
five.2.3) Name and address of the contractor
Patheon UK Limited
Patheon Building, Kingfisher Drive, Covingham
Swindon
SN3 5BZ
Country
United Kingdom
NUTS code
- UKK1 - Gloucestershire, Wiltshire and Bristol/Bath area
National registration number
3764421
The contractor is an SME
No
five.2.4) Information on value of contract/lot (excluding VAT)
Total value of the contract/lot: £815,555
Section six. Complementary information
six.4) Procedures for review
six.4.1) Review body
Royal Courts of Justice
London
Country
United Kingdom