Octapharma appointed sole fractionator for UK's plasma for medicines programme

In 2021, a long-standing ban on the use of UK plasma for the manufacture of immunoglobulins was removed after a review by the Commission on Human Medicines (CHM), an independent body that advises the UK government, deemed that UK plasma is safe to use. The ban was introduced in 1998 due to concerns over the transmission of Creutzfeldt-Jakob Disease (vCJD).

Following the lifting of the ban, the UK government appointed National Health Service (NHS) England to lead a procurement process to select a manufacturer to provide fractionation and product manufacturing services using UK plasma.

Following a highly competitive tendering process, Octapharma was selected in July 2023 to be the sole fractionator for the UK's plasma for medicines programme.

“The Octapharma team responded to this exciting opportunity with a comprehensive and competitive bid and we are proud to have been appointed the sole fractionator for this highly strategic and important project,” says Clare Worden, General Manager UK and Ireland. “We look forward to working closely with the NHS in the coming years to provide patients with the plasma medicines they need.”

The NHS annual collection target of approximately 300,000 litres of plasma will provide approximately 80% self-sufficiency of albumin and around 30% for immunoglobulin, building resilience with these products in the UK.

Initiated on behalf of the Department of Health and Social Care the plasma for medicines programme is a crucial element in the UK’s effort to reduce sole reliance on external plasma sources and to ensure a stable, safe, and affordable supply of these essential therapies for patients nationwide.

Throughout the multi-year programme and starting in 2024, an annual volume of approximately 300,000 litres of UK plasma will be shipped to Octapharma, with production taking place in our European manufacturing sites in Springe and Stockholm. The first domestically sourced immunoglobulin and albumin products are expected to be available to NHS patients in the UK by early 2025.

About the Programme

NHSBT has established dedicated plasma donor centres in selected UK towns (Reading, Twickenham, and Birmingham), with plans for further expansion. These centres collect plasma through plasmapheresis, and additional plasma is recovered from whole blood donations. The collected plasma is stored and will be processed into medicines by Octapharma, one of the world’s largest plasma fractionators. Octapharma was selected in July 2023 to provide these services through a procurement process led by NHS England.

Background

In 1998, the UK imposed a ban on using domestic plasma for manufacturing PDMPs due to concerns about variant Creutzfeldt- Jakob Disease (vCJD). Consequently, the UK depended on imported plasma, primarily from the United States, to meet its PDMP needs. In 2021, following a comprehensive safety review, the Medicines and Healthcare products Regulatory Agency (MHRA) lifted the ban, deeming UK-sourced plasma safe for producing these treatments.