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The Development, Validation and Supply of Physostigmine Free Base

Ministry of Defence, Defence Science and Technology Laboratory

This public procurement record has 1 release in its history.

Tender

28 Mar 2023 at 16:22

Tender Notice
Summary of the contracting process

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.

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Notice Information

Notice Title

The Development, Validation and Supply of Physostigmine Free Base

Notice 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).

Notice Details

Publication & Lifecycle

Open Contracting ID
ocds-h6vhtk-03b6c1
Publication Source
Find A Tender Service
Latest Notice
https://www.find-tender.service.gov.uk/Notice/009030-2023
Current Stage
Tender
All Stages
Tender

Procurement Classification

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

Common Procurement Vocabulary (CPV)

CPV Divisions

33 - Medical equipments, pharmaceuticals and personal care products

73 - Research and development services and related consultancy services

CPV 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

Notice Value(s)

Tender Value
£10,000,000 £10M-£100M
Lots Value
Not specified
Awards Value
Not specified
Contracts Value
Not specified

Notice Dates

Publication Date
28 Mar 20233 years ago
Submission Deadline
28 Apr 2023Expired
Future Notice Date
Not specified
Award Date
Not specified
Contract Period
Not specified - Not specified
Recurrence
Not specified

Notice Status

Tender Status
Active
Lots Status
Not Specified
Awards Status
Not Specified
Contracts Status
Not Specified

Buyer & Supplier

Contracting Authority (Buyer)

Main Buyer
Ministry of Defence, Defence Science and Technology Laboratory
Contact Name
Available with D3 Tenders Premium →
Contact Email
Available with D3 Tenders Premium →
Contact Phone
Available with D3 Tenders Premium →

Buyer Location

Locality
SALISBURY, WILTSHIRE
Postcode
SP4 0JQ
Postcode Area
Salisbury
Country
England
Major Region (ITL 1)
TLK South West (England)
Basic Region (ITL 2)
TLK7 Gloucestershire and Wiltshire
Small Region (ITL 3)
TLK72 Wiltshire
Delivery Location
Not specified
Local Authority
Wiltshire
Electoral Ward
Winterslow & Upper Bourne Valley
Westminster Constituency
Salisbury

Further Information

Notice Documents

Open Contracting Data Standard (OCDS)

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The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts.

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