The Development, Validation and Supply of Physostigmine Free Base

{
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    "id": "ocds-h6vhtk-03b6c1-2023-03-28T16:22:22+01:00",
    "date": "2023-03-28T16:22:22+01:00",
    "ocid": "ocds-h6vhtk-03b6c1",
    "description": "The Contracting Authority intends to use an e-Tendering system in this procurement exercise, please visit www.contracts.mod.uk for full details and to register your interest in this procurement. The Cyber Risk Profile for this requirement identified by the Cyber Risk Assessment is Very Low (Reference - RAR-800645056).",
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        "title": "The Development, Validation and Supply of Physostigmine Free Base",
        "status": "active",
        "classification": {
            "scheme": "CPV",
            "id": "33661700",
            "description": "Other nervous system medicinal products"
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                "scheme": "CPV",
                "id": "33660000",
                "description": "Medicinal products for the nervous system and sensory organs"
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            {
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                "id": "33690000",
                "description": "Various medicinal products"
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                "description": "Design and execution of research and development"
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                "description": "Purchase"
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        "mainProcurementCategory": "goods",
        "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 1,2,3,3ab,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).",
        "value": {
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            "amount": 10000000
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                    "description": "Suppliers Instructions How to Express Interest in this Tender: 1. Register your company on the eSourcing portal (this is only required once) - Browse to the eSourcing Portal - Click the \"Click here to register\" link - Accept the terms and conditions and click \"continue\" - Enter your correct business and user details - Note the username you chose and click \"Save\" when complete - You will shortly receive an email with your unique password (please keep this secure) 2. Express an Interest in the tender - Login to the portal with the username/password - Click the \"PQQs Open to All Suppliers\" link. (These are Pre-Qualification Questionnaires open to any registered supplier) - Click on the relevant PQQ to access the content. - Click the \"Express Interest\" button in the \"Actions\" box on the left-hand side of the page. - This will move the PQQ into your \"My PQQs\" page. (This is a secure area reserved for your projects only) - Click on the PQQ code, you can now access any attachments by clicking the \"Settings and Buyer Attachments\" in the \"Actions\" box 3. Responding to the tender - You can now choose to \"Reply\" or \"Reject\" (please give a reason if rejecting) - You can now use the 'Messages' function to communicate with the buyer and seek any clarification - Note the deadline for completion, then follow the onscreen instructions to complete the PQQ - There may be a mixture of online & offline actions for you to perform (there is detailed online help available) If you require any further assistance please consult the online help, or contact the eTendering help desk.",
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                    "description": "See PQQ",
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            "id": "GB-FTS-77694",
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                "locality": "Salisbury, Wiltshire",
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