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.3) Communication
The procurement documents are available for unrestricted and full direct access, free of charge, at
https://uk.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=38809&B=EXETER
Additional information can be obtained from the above-mentioned address
Tenders or requests to participate must be submitted electronically via
https://uk.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=38809&B=EXETER
Tenders or requests to participate must be submitted to the above-mentioned 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
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.1.5) Estimated total value
Value excluding VAT: £500,000
two.1.6) Information about lots
This contract is divided into lots: No
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 is not the only award criterion and all criteria are stated only in the procurement documents
two.2.6) Estimated value
Value excluding VAT: £500,000
two.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months
18
This contract is subject to renewal
No
two.2.10) Information about variants
Variants will be accepted: No
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 three. Legal, economic, financial and technical information
three.1) Conditions for participation
three.1.2) Economic and financial standing
Selection criteria as stated in the procurement documents
three.1.3) Technical and professional ability
Selection criteria as stated in the procurement documents
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.2.2) Time limit for receipt of tenders or requests to participate
Date
16 August 2021
Local time
12:00pm
four.2.4) Languages in which tenders or requests to participate may be submitted
English
four.2.7) Conditions for opening of tenders
Date
16 August 2021
Local time
12:00pm
Section six. Complementary information
six.1) Information about recurrence
This is a recurrent procurement: No
six.4) Procedures for review
six.4.1) Review body
Royal Courts of Justice
London
Country
United Kingdom