--- title: "The Development, Validation and Supply of Physostigmine Free Base" ocid: "ocds-b5fd17-2cf514ff-1d1d-4618-a672-9fb5a857fb99" canonical_url: "https://d3tenders.com/contract/?ocid=ocds-b5fd17-2cf514ff-1d1d-4618-a672-9fb5a857fb99" markdown_url: "https://d3tenders.com/contract/ocds-b5fd17-2cf514ff-1d1d-4618-a672-9fb5a857fb99.md" json_url: "https://d3tenders.com/contract/ocds-b5fd17-2cf514ff-1d1d-4618-a672-9fb5a857fb99.json" source: "Contracts Finder" current_stage: "Tender" buyer: "MINISTRY OF DEFENCE" published: "2023-03-28" --- # The Development, Validation and Supply of Physostigmine Free Base Buyer: MINISTRY OF DEFENCE Current stage: Tender OCID: ocds-b5fd17-2cf514ff-1d1d-4618-a672-9fb5a857fb99 [View canonical contract page](https://d3tenders.com/contract/?ocid=ocds-b5fd17-2cf514ff-1d1d-4618-a672-9fb5a857fb99) [Download OCDS JSON](https://d3tenders.com/contract/ocds-b5fd17-2cf514ff-1d1d-4618-a672-9fb5a857fb99.json) ## Summary The Ministry of Defence (MoD) is seeking proposals for the development, validation, and supply of Physostigmine Free Base, necessary for an ongoing product development and eventual commercialization. The procurement method being used is a Competitive Procedure with Negotiation, with a tender period ending on 28th April 2023. The contract period is set to start on 30th October 2023 and end on 29th October 2038. The procurement falls under the classification of 'Other nervous system medicinal products', with the location specified as Porton Down, Salisbury, Wiltshire, SP4 0JQ, United Kingdom. This tender presents an opportunity for businesses specializing in pharmaceuticals and active pharmaceutical ingredients within the nervous system medicinal products category to engage with the Ministry of Defence. The Ministry intends to seek Marketing Authorisation for the final medicinal product, creating space for collaboration in product development and manufacturing. Businesses well-versed in Good Manufacturing Practice (GMP) and European Transmissible Spongiform Encephalopathies (TSE) requirements would be well-suited to compete in this procurement process, given the strict regulatory standards involved. ## Notice 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 1,2,3,3ab,8,8ab-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 ## Key Details | Field | Value | | --- | --- | | Publication source | Contracts Finder | | Latest notice | https://www.contractsfinder.service.gov.uk/Notice/75a06917-1173-45c3-a74c-220b5867dddd | | Notice type | Tender Notice | | Procurement type | Standard | | Procurement category | Goods | | Procurement method | Selective | | Procurement method details | Competitive procedure with negotiation (above threshold) | | Tender suitability | Not specified | | Awardee scale | Not specified | | All stages | Tender | ## Dates | Field | Value | | --- | --- | | Publication date | 28 Mar 2023 | | Submission deadline | 28 Apr 2023 | | Future notice date | Not specified | | Award date | Not specified | | Contract period | 30 Oct 2023 - 29 Oct 2038 | | Recurrence | Not specified | ## Values | Field | Value | | --- | --- | | Tender value | Not specified | | Lots value | Not specified | | Awards value | Not specified | | Contracts value | Not specified | ## Status | Field | Value | | --- | --- | | Tender status | Active | | Lots status | Not specified | | Awards status | Not specified | | Contracts status | Not specified | ## Buyer | Field | Value | | --- | --- | | Main buyer | MINISTRY OF DEFENCE | | Locality | SALISBURY, WILTSHIRE | | Post town | Salisbury | | Postcode | SP4 0JQ | | Country | England | | ITL 1 | TLK South West (England) | | ITL 2 | TLK7 Gloucestershire and Wiltshire | | ITL 3 | TLK72 Wiltshire | | Local authority | Wiltshire | | Electoral ward | Winterslow & Upper Bourne Valley | | Westminster constituency | Salisbury | | Delivery location | TLK South West (England) | ## CPV Codes ### Divisions - 33 - Medical equipments, pharmaceuticals and personal care products ### Codes - 33661700 - Other nervous system medicinal products ## Release History - 28 Mar 2023 at 15:46 - Tender - Tender Notice - https://www.contractsfinder.service.gov.uk/Notice/75a06917-1173-45c3-a74c-220b5867dddd ## Documents - https://www.contractsfinder.service.gov.uk/Notice/75a06917-1173-45c3-a74c-220b5867dddd 28th March 2023 - Opportunity notice on Contracts Finder ## Provenance This Markdown file is an alternate public rendering of the D3 Tenders contract record. The canonical page is https://d3tenders.com/contract/?ocid=ocds-b5fd17-2cf514ff-1d1d-4618-a672-9fb5a857fb99. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-b5fd17-2cf514ff-1d1d-4618-a672-9fb5a857fb99.json.