NCA30963 GMP Mangafodipir

Concepts

• edinburgh
• reagents and contrast media
• regulation reg
• good manufacturing practice preparation of mangafodipir
• nca30963 gmp mangafodipir
• technical reasons
• case of a public contract
• negotiated procedure
• scotland
• prior publication

Location

CENTRE FOR CARDIOVASCULAR RESEARCH THE UNIVERSITY OF EDINBURGH CHANCELLOR'S BUILDING 49 LITTLE FRANCE CRESCENT EDINBURGH EH16 4SB

Description

Formulation and Good Manufacturing Practice preparation of mangafodipir for clinical use in healthy volunteers and patients.

Total Quantity or Scope

Under Regulation Reg 33(1)(b)(ii) of the Public Contracts (Scotland) Regulations 2015, a contracting authority may use the negotiated procedure without the prior publication in the case of a public contract, based on the following justification: 2. Competition is absent for technical reasons (only if it is not caused by artificial narrowing down of the parameters of the procurement and no reasonable alternative or substitute exists);

Award Detail

Renewal Options

If the initially feasibility study is successful, the production and stability testing of mangafodipir is included in the procurement at the cost of 244,105 USD excluding VAT.

Award Criteria

CPV Codes

• 33696000 - Reagents and contrast media

Indicators

• Options are available.

Legal Justification

For the last 2 years, we have been trying to source further preparations of the mangafodipir. This has included a global search for suppliers which has been unsuccessful. We are working with a Norwegian company to provide the product but has proved unsuccessful although future supplies may be possible in 1-2 years’ time. However, we have ongoing clinical trials and need a supply as soon as possible. We have now engaged with Avomeen (Element) who have previous experience with working with the product: this is quite unique with no other supplier having this experience. The product is rather complex to manufacture and formulate and given that they are the only current provider to generate the product and have the expertise, we have gone back to them. They seem to be the only company able to deal with the complexity of manufacture. The other issue is availability. The world’s supply and capacity for sterile fill products is severely stretched due to the massive global demand for SARS-CoV2 vaccines. We have worked with Element to try alternative sterile fill premises but there is no capacity in other facilities for the immediate future.

Other Information

** PREVIEW NOTICE, please check Find a Tender for full details. ** (SC Ref:662323)