--- title: "The Development, Validation and Supply of Physostigmine Free Base" ocid: "ocds-h6vhtk-03b6c1" canonical_url: "https://d3tenders.com/contract/?ocid=ocds-h6vhtk-03b6c1" markdown_url: "https://d3tenders.com/contract/ocds-h6vhtk-03b6c1.md" json_url: "https://d3tenders.com/contract/ocds-h6vhtk-03b6c1.json" source: "Find A Tender Service" current_stage: "Tender" buyer: "MINISTRY OF DEFENCE, DEFENCE SCIENCE AND TECHNOLOGY LABORATORY" published: "2023-03-28" --- # The Development, Validation and Supply of Physostigmine Free Base Buyer: MINISTRY OF DEFENCE, DEFENCE SCIENCE AND TECHNOLOGY LABORATORY Current stage: Tender OCID: ocds-h6vhtk-03b6c1 [View canonical contract page](https://d3tenders.com/contract/?ocid=ocds-h6vhtk-03b6c1) [Download OCDS JSON](https://d3tenders.com/contract/ocds-h6vhtk-03b6c1.json) ## Summary The Ministry of Defence (MoD) is seeking proposals for the provision of Physostigmine Free Base, an active ingredient for a medicinal product currently under development. The contract has a value of GBP 10,000,000 with a minimum value of GBP 3,000,000. The procurement method is selective, with a tender period ending on 28th April 2023. The opportunity involves a 10-year contract duration with potential for 5 optional years. The contracting authority is the Ministry of Defence, Defence Science and Technology Laboratory based in Salisbury, Wiltshire, United Kingdom. The industry category is "Other nervous system medicinal products." This tender presents an opportunity for pharmaceutical companies specialising in the development and manufacturing of medicinal products, specifically those experienced in providing Active Pharmaceutical Ingredients (API) for clinical settings. Businesses with expertise in Good Manufacturing Practice (GMP) and European Transmissible Spongiform Encephalopathies (TSE) requirements are well-suited to compete. The Ministry of Defence plans to seek Marketing Authorisation for the final medicinal product, requiring suppliers to provide Chemistry, Manufacturing and Control documentation. Subcontracting opportunities are available, and interested parties can register on the eSourcing portal for further details. ## 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 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). ## Key Details | Field | Value | | --- | --- | | Publication source | Find A Tender Service | | Latest notice | https://www.find-tender.service.gov.uk/Notice/009030-2023 | | Notice type | Tender Notice | | Procurement type | Standard | | Procurement category | Goods | | Procurement method | Selective | | Procurement method details | Negotiated | | 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 | Not specified | | Recurrence | Not specified | ## Values | Field | Value | | --- | --- | | Tender value | £10,000,000 | | 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, DEFENCE SCIENCE AND TECHNOLOGY LABORATORY | | 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 | Not specified | ## CPV Codes ### Divisions - 33 - Medical equipments, pharmaceuticals and personal care products - 73 - Research and development services and related consultancy services ### Codes - 33660000 - Medicinal products for the nervous system and sensory organs - 33661700 - Other nervous system medicinal products - 33690000 - Various medicinal products - 73300000 - Design and execution of research and development ## Release History - 28 Mar 2023 at 15:22 - Tender - Tender Notice - https://www.find-tender.service.gov.uk/Notice/009030-2023 ## Documents - www.contracts.mod.uk ## Notice URLs - http://www.contracts.mod.uk ## 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-h6vhtk-03b6c1. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-h6vhtk-03b6c1.json.