Tender

The Development, Validation and Supply of Physostigmine Free Base

MINISTRY OF DEFENCE

This public procurement record has 1 release in its history.

Tender

28 Mar 2023 at 15:46

Tender Notice
Summary of the contracting process

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.

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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

Notice Details

Publication & Lifecycle

Open Contracting ID
ocds-b5fd17-2cf514ff-1d1d-4618-a672-9fb5a857fb99
Publication Source
Contracts Finder
Latest Notice
https://www.contractsfinder.service.gov.uk/Notice/75a06917-1173-45c3-a74c-220b5867dddd
Current Stage
Tender
All Stages
Tender

Procurement Classification

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

Common Procurement Vocabulary (CPV)

CPV Divisions

33 - Medical equipments, pharmaceuticals and personal care products

CPV Codes

33661700 - Other nervous system medicinal products

Notice Value(s)

Tender Value
Not specified
Lots Value
Not specified
Awards Value
Not specified
Contracts Value
Not specified

Notice Dates

Publication Date
28 Mar 20232 years ago
Submission Deadline
28 Apr 2023Expired
Future Notice Date
Not specified
Award Date
Not specified
Contract Period
30 Oct 2023 - 29 Oct 2038 Over 5 years
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
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
Post Town
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
TLK South West (England)
Local Authority
Wiltshire
Electoral Ward
Winterslow & Upper Bourne Valley
Westminster Constituency
Salisbury

Further Information

Notice Documents

Open Contracting Data Standard (OCDS)

View full OCDS Record for this contracting process

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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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