Z Geburtshilfe Neonatol 2013; 217 - V25_4
DOI: 10.1055/s-0033-1361352

Plasma collection for production of Tromplate®, a hyperimmune anti-HPA-1a for the prevention of foetal and neonatal alloimmune thrombocytopenia

K Järås 1, on behalf of the PROFNAIT consortium
  • 1PROFNAIT consortium, Tromsø, Norway

Aim: Foetal/Neonatal Alloimmune Thrombocytopenia (FNAIT) is a rare but potentially very serious condition that occurs in about 1 out of 2000 pregnancies. The condition is characterized by destruction of the platelets of the foetus or newborn due to maternal alloantibodies most commonly directed to the Human Platelet Antigen 1a (HPA-1a). The foetus or newborn becomes thrombocytopenic and is at risk of intracranial haemorrhage, which may result in lifelong disability or death. Currently no satisfactory preventive treatment exists for this rare but potentially life-threatening condition. The PROFNAIT consortium is an EU-funded collaboration between universities, hospitals and pharmaceutical industry with the aim to develop a medicinal product named Tromplate® for preventing FNAIT.

Methodology: The theory behind this prophylactic treatment is based on research that shows a closer similarity between FNAIT and Hemolytic Disease of the Foetus and Newborn (HDFN) than previously believed. The discovery opens for the possibility to prevent the development of maternal antibodies against HPA-1a, in the same manner as has been done to prevent the development of anti-Rh(D) antibodies related to HDFN since the mid-sixties. Tromplate® is intended to be given after birth to clear the foetal HPA-1a positive platelets from the mother's blood. This medicinal product will be produced from plasma collected from women who previously have had a pregnancy complicated with FNAIT.

Results: At date more than 350 liter of plasma including the rare plasma from HPA-1a negative women hosting anti-HPA-1a antibodies have been collected for manufacturing of the Tromplate® hyperimmune. This work describes the rational behind the collaborative plasma collection within the PROFNAIT project.

Conclusion: The PROFNAIT consortium has with internationally joint forces taken a first step towards the manufacturing of clinical trial material to develop a polyclonal antibody-based prophylaxis preventing FNAIT.