01 March 2021

The UK is to restart manufacture of immunoglobin therapies from UK-sourced blood plasma after a gap of more than 20 years, it was announced last week. The decision opens the way for developing immunoglobin products specifically aimed at COVID-19, as well as other immune diseases.

The ban was introduced in 1998 amid concern about the spread of variant Creutzfeldt-Jakob Disease, which entered the human population through contaminated meat from animals with BSE.

The decision follows a comprehensive review of the evidence on the safety of UK blood plasma undertaken at the end of last year by the Medicines and Healthcare products Regulatory Agency (MHRA), the government said.

It said the lifting of the ban would make the UK “more self-sufficient” in producing these medicines. 250,000 litres of plasma collected through blood donations are currently discarded every year.

MHRA chief executive Dr June Raine said the review had been “thorough.”

Dr Raine said: “Patient safety is at the forefront of all the work we do, and as with any medicine available in the UK, the MHRA ensures that robust safety standards have been met before treatments made from plasma can be given to the public.”

NHS Blood and Transplant currently collects around 350,000 litres of plasma each year as part of their ongoing whole blood donations for hospitals. 100,000 litres of this is used for transfusion and the remaining 250,000 is discarded or not used to manufacture medicines, as it is common practice in other countries where a ban is not in place.

Following the decision to lift the ban, the whole blood donations from generous donors will be used to save and improve even more lives, by using the plasma from those whole blood donations to also make medicines for patient care.

NHS Blood and Transplant chief executive Betsy Basis said: “There is growing global demand for these vital medicines so it’s important that the UK develops its own supply for UK patients.

“We also look forward to exploring the opportunity of fractionating convalescent plasma for the production of hyper-immunoglobulins to treat COVID-19.”

Health minister Lord Bethell said: “The safety of NHS patients remains our absolute priority and we have put in place robust precautionary measures to ensure every batch is safe.”

Convalescent plasma is currently being trialled in the UK for the treatment of COVID-19 and, if the results are positive, this would mean immunoglobulins from plasma donated in the UK could in future be used as immunoglobulins to treat coronavirus patients.

Source: UK Department of Health



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