Open Orphan subsidiary Hvivo has been chosen to lead a consortium on behalf of international researcher network HIC-Vac and and the Wellcome Trust to generate regulatory style guidelines on the manufacture of human challenge agents for use in controlled human infection studies.
HIC-Vac is a network of researchers who are developing human infection challenge studies to accelerate the development of vaccines against pathogens.
The consortium is aiming to develop international standards for the manufacturing and storage of challenge agents, extending the current general WHO guidelines relating to challenge studies. It intends to create guidance that meets Good Manufacturing Practice (GMP) requirements as much as is practically possible to ensure safety, quality and consistency are maintained, while allowing flexibility to manufacture challenge agents outside of GMP-certified premises.
"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 guideline," said Cathal Friel, executive chairman of Open Orphan.
“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.”
The guidance will be produced in consultation with a range of researchers currently working with different challenge agents as well as with input from regulatory experts, and regulatory or advisory bodies.
"Today's announcement shows the continued commitment of the infectious disease community in progressing designs and capabilities for research into bacteria, parasites and viruses," said Andrew Catchpole, chief scientific officer with Hvivo.