Request for Information - Lyophilisation Services

Description

The purpose of this document is to enhance the Authority’s understanding of the marketplace and its options for sourcing for a potential future requirement. The issuance of this request for information (RFI) does not constitute a sourcing exercise nor will the Authority pay any costs incurred in the preparation of a response to this RFI. The UK Health Security Agency’s (UKHSA) key objectives for this RFI are: understand the ability of the marketplace to fulfil its requirements; refine the scope of the requirements to best align to the marketplace; and inform the Authority’s chosen route to market to best enable competition The key dates for this RFI are as follows: RFI Published: 30th June 2026 RFI Response: 14th July 2026 Should you have any questions or queries relating to this RFI, please use the Atamis portal’s messaging centre to direct your questions to us for a response. If a response is not received by the RFI response deadline this will have no impact on your ability to tender for the opportunity in the future. UKHSA will not enter into contracts on the basis of replies to this RFI. Description of Scope of Requirements: The UK Health Security Agency (UKHSA) is responsible for protecting every member of every community from the impact of infectious diseases, chemical, biological, radiological and nuclear incidents and other health threats. We provide intellectual, scientific and operational leadership at national and local level, as well as on the global stage, to make the nation's health secure. Background: UKHSA is seeking to engage with the market to better understand supplier capability for the provision of lyophilisation (freeze-drying) services for X-ray irradiated pathogens to provide greater resilience and flexibility across use cases as part of UKHSA’s Pandemic Preparedness strategy. UKHSA requires support in developing optimal formulations and lyophilisation processes to ensure that irradiated, inactivated pathogens can be safely stored, handled, and distributed for diagnostic use and pandemic preparedness. Lyophilisation is required to enhance the long-term stability and usability of these materials, supporting strategic resilience and response capabilities. Requirements: We need the supplier to have: • Ability to handle irradiated, inactive viral and bacterial material in liquid medium • Ability to develop and optimise lyophilisation protocols including assessment of different stabilisation matrices • Appropriate quality system in place (at least ISO 9001) to ensure consistency and traceability • Provide product quality control (QC) testing of final product, including thermal stability and absence of contaminants. • Overall aim is to lyophilise up to 20 pathogens over the next 4 years o Estimated vial volume for lyophilisation is 0.3mL – 2mL o Estimated batch size for lyophilisation is 6 – 100mL o Estimated number of batches per year is 5 Should you wish to respond to this Request for Information, please complete the response questionnaire which is found at the following link: https://atamis-1928--prospend.vf.force.com/apex/CS_ContractPage?filters=&page=1&Preview=Yes&searchStr=&SearchType=Projects&sortStr=Alphabetical&uid=a07Pz00001jEyqdIAC&sfdcIFrameOrigin=https%3A%2F%2Fatamis-1928.lightning.force.com