Unlocking Space for Business: In-orbit R&D and manufacturing of pharmaceuticals RFI

What the buyer says

The UK Space Agency is working across government, regulators, industry and healthcare to help create the conditions needed for the in-orbit pharmaceuticals manufacturing and drug discovery market to develop. USB has played a convening role in bringing together the Medicines and Healthcare products Regulatory Agency (MHRA), the Civil Aviation Authority (CAA) and the Regulatory Innovation Office (RIO) within the Department for Business, Innovation, Science and Trade (BIST) to publish a joint statement on regulatory clarity for in-orbit manufacturing of pharmaceuticals. We are also working with MHRA to develop a regulatory roadmap for space-enabled pharmaceutical manufacturing, to provide greater clarity and confidence for industry. Following sustained evidence-gathering from the Unlocking Space Portfolio, including participation in the recent UK-Swiss Microgravity Biopharma Dialogue, clear pain-points and barriers to the adoption of in-orbit manufacturing of pharmaceuticals have emerged, which are currently experienced by UK stakeholders including prospective end-users, space biotech companies and investors. This Request for Information (RFI) builds directly on this Dialogue, and the questions below are designed to test, validate and extend that evidence base with wider stakeholder input. The UK Space Agency requests your input to ensure that any future support or commercialisation opportunities for in-orbit manufacturing of pharmaceuticals or in-orbit R&D directly address these identified barriers and are prioritised based on the needs of stakeholders in this domain. This RFI will help guide the UK Space Agency’s interventions for space biopharma companies, prospective pharmaceutical end-users and space/biotech investors. This RFI is not directly connected to an exist…