Defence Online

Type of document: Contract Notice
Country: United Kingdom

1. Title: The Development, Validation and Supply of Physostigmine Free Base
2. Awarding Authority:
Ministry of Defence
Porton Down

Salisbury, Wiltshire
England
SP4 0JQ
Contact:
Email: ADPProcurement@dstl.gov.uk
Phone:
URL:
3. Contract Type: Products
4. 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
5. CPV Codes:
33661700 – Other nervous system medicinal products
6. NUTS Codes: UKK15
7. Main Site or Location of Works, Main Place of Delivery or Main Place of Performance: South West
8. Reference Attributed by the Awarding Authority:
tender_306287/1197057
9. Estimated Value of Requirement: Not Provided
10. Start Date: 30/10/2023
11. End Date: 29/10/2038
12. Closing Date: 28/04/2023
13. Other Information:
Additional Text

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