Ever since the outbreak of variant Creutzfeldt-Jakob disease in the UK in the 1990s, the country has banned drugmakers from using UK-sourced blood plasma in their therapies. This ban has now been lifted, following an extensive review of the safety evidence. Abi Millar looks into the risk-benefit analysis of freeing up the UK life sciences sector to produce blood plasma domestically once more.
On 7 April, people in the UK were permitted to donate blood plasma for medicines for the first time in over 20 years. The plasma, which will be used to manufacture immunoglobulins, is being collected by NHS Blood and Transplant (NHSBT) at 14 sites as part of an initial three-month trial period.
“NHSBT already collects some plasma during whole blood donation but a dedicated plasmapheresis programme will greatly increase NHSBT’s ability to provide plasma at volume,” said NHSBT’s chief medical officer Dr Gail Miflin. “This will play an important part in reducing the UK’s reliance on plasma donated in the US.”
It’s a landmark moment for patients. For those whose immune systems aren’t working properly – either because of genetic disorders or cancer treatment – immunoglobulin (antibody-based) therapies can be lifesaving.
The same applies to those with a range of neurological, haematological and dermatological conditions, including Guillain-Barre syndrome, cytopenia and Kawasaki syndrome. Around 17,000 people in the UK needed immunoglobulin therapy in 2018/19, receiving 5.5 million doses overall.
Unfortunately, the NHS has long grappled with plasma shortages, and in turn a limited supply of medications. Since 1999, there has been a ban on using plasma from UK donors, as a preventative measure against variant Creutzfeldt-Jakob disease (vCJD).
Read the rest of this article in the July 2021 edition of Pharma Technology Focus