Ministry of Defence, Defence Science and Technology Laboratory
The Development, Validation and Supply of Physostigmine Free Base
The procurement contact named on the official notice.
The submission route named on the official notice.
This is a large award for Medical Equipment & Pharmaceuticals — above three-quarters of comparable contracts. Based on 9,456 valued Medical Equipment & Pharmaceuticals tenders in our corpus.
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 Quantity or scope: The Contract has an expected duration of 10 years (120 months), plus 5 option years (60 months).
Option years may be taken up consecutively or concurrently (to be determined).
What the supplier must deliver
The initial Physostigmine supplied must be suitable
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 API must be developed and manufactured
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.
Derived from the notice text — always confirm against the original documents.
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- OCID
- ocds-h6vhtk-03b6c1
- Stage
- tender · Open
- Source
- Find a Tender
- Buyer ref
- 009030-2023
Contains public sector information licensed under the Open Government Licence v3.0. Source data © Crown copyright.
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