Legislative U-turn on blood plasma use for immunoglobulin treatment

pharmafile | August 17, 2021 | News story | Manufacturing and Production  

Plasma from blood donations in England will now be used for immunoglobulin treatments in a U-turn in regulation that was previously in place to protect patients against mad cow disease (vCJD).

Currently, the UK relies solely on plasma imports, which can be in short supply – a situation made worse by the pandemic.

The move will help secure NHS stocks, and rollout of the service will happen across England over the coming months, and NHS blood donor services elsewhere in the UK could opt to do the same.

Gerry Gogarty, from NHS Blood and Transplant, said: “By recovering plasma from blood donations, we can improve long-term supplies of immunoglobulin medicine, and each generous blood donation will go even further in helping to save the lives.”

The immunoglobulin treatment can be used to help patients who cannot make antibodies themselves, or in circumstances where their bodies are not making enough antibodies, or the ones they are making don’t work properly, as well as for disorders when the body’s immune system is attacking itself.

The red blood cells from donations will continue to be used as normal, so there will be no impact on donor blood stocks. Plasma is the fluid and other cells and components of whole blood.

Each year about 17,000 people need immunoglobulin treatment, and the Commission on Human Medicines (CHM) has concluded that the risk of vCJD cases arising from the use of UK plasma for the manufacture of immunoglobulin medicinal products would be negligible.

The CHM advised that UK-sourced plasma is acceptably safe for the manufacture of immunoglobulin medicinal products provided the following risk-mitigation measures are adhered to:

  • All relevant risk-mitigation measures already in place for blood components for transfusion (the use of leucodepletion, deferral of high-risk donors and traceability between donor and recipient) should be applied to UK-sourced plasma for the manufacture of immunoglobulins.
  • Manufacturers should be required to submit an application to vary the terms of their existing licences to introduce the use of UK-sourced plasma. The product-specific risk assessment and an evaluation of the prion reduction capacity of the product manufacturing process, will be required. Each product will need to be individually reviewed and evaluated by the MHRA, and advice sought from the CHM’s Clinical Trials, Biologicals and Vaccines Expert Advisory Group and CHM.

Kat Jenkins

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