Public procurement notice: Contract Notice
Published: 2019-11-20
Buyer: Ministry of Defence, ISTAR, Chemical, Biological, Radiological and Nuclear Delivery Team (CBRN DT)
Country: UK
Contract type: Supplies
Procedure: Negotiated procedure
CPV classification: 24000000 | 24950000 | 33000000 | 33140000: Medical consumables | 33600000: Pharmaceutical products
Estimated value:  GBP
Submission deadline: 2019-12-17
Award criteria: The most economic tender

Technical requirements: Pharmaceutical products, pharmaceutical articles, medical equipments, pharmaceuticals and personal care products, medical consumables, chemical products, specialised chemical products, nuclear, biological, chemical and radiological protection equipment,
the chemical biological radiological and nuclear protection delivery team is inviting expressions of interest in respect of a proposed contract for the development, process validation, manufacture and supply of physostigmine free base as an active pharmaceutical ingredient (API) for use in a Ministry of Defence (MOD) final medicinal product currently under development.
The supplier will be required to develop, scale-up and validate the manufacturing method, define a detailed specification and full characterisation of the API, Physostigmine (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)
The supplier will be required to supply the authority with full information on the manufacture and control of the API as described in Annex I to Directive 2001/83/EC as amended (with particular reference to Part I, Section 3) and elaborated in the notice to applicants (Eudralex Volume 2: https://ec.europa.eu/health/documents/eudralex/vol-2_en).
The specification should meet modern standards and best endeavours should be taken to remove processing impurities. The specification should align with current regulatory requirements for active pharmaceutical ingredients (including Ph.Eur). The supplier will also be expected to analyse a sample (as much as is required) of the authority’s existing physostigmine API material, to assess the comparability of the 2 (to permit bridging between studies using old versus new material). The authority will review the comparability and determine whether the specification of the new API is acceptable.
The supplier will be required to conduct appropriate stability studies as often as required as per the international conference on harmonisation (standard and accelerated), forced degradation and provide data in the form of a written report (including protocol(s)) to support the shelf life to be applied. A shelf life of at least 3 years under storage conditions 2-8ºC is required.
The supplier will prepare a primary reference standard no later than the day of commencement of performance validation batches. This standard will be tested throughout its shelf life to maintain its usability and where necessary replaced with a new standard. This standard must be sufficient for all testing required throughout the life of the contract and the authority reserves the right to request quantities on an ad-hoc basis.
The supplier will be responsible for delivering a laboratory scale batch within the first year of the contract, by 31.3.2021. Subject to successful completion of laboratory scale manufacture, the supplier will be responsible for a pilot scale up manufacture of an 8-10 kg batch (no less than 8 kg). Physostigmine produced at the pilot scale must be suitable for use in pivotal clinical trials and commercial manufacturing.
During the first option period (years 2 to 5 of the potential contract), the supplier will be responsible for establishing a scalable manufacturing process and delivery schedule capable of manufacturing up to 40 kg annually to meet the authority’s requirement, with the minimum requirement being manufacture and delivery of 10 kg.
This requirement includes validation of manufacturing process and analytical assays and the manufacture of 3 validation batches and characterisation of the API.
1) That MOD intends to seek a marketing authorisation for the final medicinal product from the medicines and healthcare products regulatory agency and physostigmine will be required as an active ingredient for the registered medicinal product;
2) 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.
First option period (4 years - April 2021 to March 2025), which will become contract years 2, 3, 4 and 5.
Second option period (5 years - April 2025-March 2030), which will become contract years 6, 7, 8, 9 and 10.
The authority will apply all the offences listed in Article 39(1) of Directive 2009/81/EC (implemented as Regulation 23(1) of the Defence and Security Public Contract Regulations (DSPCR) 2011 in the UK) and all of the professional misconducts listed at Article 39(2) of Directive 2009/81/EC (see also Regulation 23(2) in the DSPCR 2011) to the decision of whether a candidate is eligible to be invited to tender.