Open Orphan PLC (LON:ORPH) said its hVIVO division has been selected to lead a consortium that has been tasked with generating regulatory style guidelines on the manufacture of human challenge agents for use in controlled human infection studies.
In doing so it will collaborate with HIC-Vac, an international network of researchers developing human infection challenge studies to accelerate the development of vaccines against pathogens, and the international medical charity, the Wellcome Trust.
hVIVO will help set international standards for challenge agent manufacture and storage, building on the current World Health Organisation guidelines.
The consortium is also working on guidance that on good manufacturing practice that stops short of GMP certification. Open Orphan said this will allow flexibility to manufacture challenge agents outside of GMP-certified premises, but with guidance to ensure safety, quality and consistency are maintained.
“We are proud to have been selected to work alongside HIC-Vac and the Wellcome Trust to lead the consortium on this important and much-needed guidelines,” said Open Orphan chairman Cathal Friel in a statement.
“hVIVO is at the forefront of human challenge studies and has world-leading capabilities, this collaboration is recognition of the work we do in the scientific community."