Published date: 28 March 2023
Closed opportunity - This means that the contract is currently closed. The buying department may be considering suppliers that have already applied, or no suitable offers were made.
Contract summary
Industry
Other nervous system medicinal products - 33661700
Location of contract
SP4 0JQ
Value of contract
£0
Procurement reference
tender_306287/1197057
Published date
28 March 2023
Closing date
28 April 2023
Closing time
5pm
Contract start date
30 October 2023
Contract end date
29 October 2038
Contract type
Supply contract
Procedure type
Competitive procedure with negotiation (above threshold)
Anyone may ask to participate, but only those who are pre-selected will be invited to submit initial tenders and to negotiate.
This procedure can be used for procurements above the relevant contract value threshold.
Contract is suitable for SMEs?
No
Contract is suitable for VCSEs?
No
Description
The Ministry of Defence (MoD) is inviting expressions of interest for a requirement for the provision of Physostigmine Free Base(also known as eserine; chemical name 1,2,3,3aβ,8,8aβ-hexahydro-1,3a,8-trimethylpyrrolo[2,3-b] indol-5-yl-methylcarbamate; chemical formula C15H21N3O2; molecular weight 275,36 g/mol). as part of an ongoing product development and anticipated commercialisation.
The initial Physostigmine supplied must be suitable for use in a pivotal Phase I clinical setting and the manufacturing process will produce material which does not add additional non-clinical activities to the overall programme, best endeavours should be taken to remove processing impurities.
The Supplier is to develop, scale-up and validate the manufacturing method for Physostigmine Free Base as an Active Pharmaceutical Ingredient (API) for use in a MoD final medicinal product currently under development.
The API must be developed and manufactured according to Good Manufacturing Practice (GMP) and must conform to European Transmissible Spongiform Encephalopathies (TSE) requirements, developed such that Intellectual property (IP) is vested in the Authority.
The Authority intends to seek a Marketing Authorisation for the final medicinal product from the Medicines and Healthcare products Regulatory Agency (MHRA) and Physostigmine will be required as an active ingredient for a future registered medicinal product.
The Supplier is required to provide information necessary for the Authority to complete the Chemistry, Manufacturing and Control (CMC) documentation to support a Clinical Trial Application (CTA) and Marketing Authorisation Application for the final medicinal product and make this documentation available to the MA applicant in an appropriate format for inclusion within CTD Module 3.
The Authority anticipates a Limited Quality by Design (QBD) approach to the manufacturing process as defined by the International Conference on Harmonisation (ICH).
All procurement documents are accessible via www.contracts.mod.uk
About the buyer
Address
Porton Down
Salisbury, Wiltshire
SP4 0JQ
England
Share this notice
Closing: 28 April 2023, 5pm
All content is available under the
