Open
The Development, Validation and Supply of Physostigmine Free Base
Descriptions
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 1,2,3,3aβ,8,8aβ-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
Timeline
Published Date :
Deadline :
Contract Start :
Contract End :
Tender Regions
Wales
CPV Codes
73300000 - Design and execution of research and development
33661700 - Other nervous system medicinal products
33660000 - Medicinal products for the nervous system and sensory organs
33690000 - Various medicinal products
Keywords
central nervous system drugs
sensory organ medications
neuro-therapeutics
neurological supportive drugs
neuroregenerative agents
CNS adjunct therapies
diverse pharmaceuticals
general drug products
healthcare medications
assorted therapeutic agents
medical product range
R&D implementation
experimental execution
innovation delivery
technical program management
end-to-end research services
research planning
product testing delivery
project coordination
prototype realization
development execution
Tender Lot Details
2 Tender Lots
Workflows
Status :
Assign to :
Tender Progress :
Details
Notice Type :
Tender Identifier :
TenderBase ID :
Low Value :
High Value :
Region :
Attachments :
Buyer Information
Address :
Website :
Procurement Contact
Name :
Designation :
Phone :
Email :
Possible Competitors
1 Possible Competitors
