Open Orphan plc (LON:ORPH), a rapidly growing specialist CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals using human challenge clinical trials, has announced that its subsidiary hVIVO has been selected to lead a consortium, on behalf of HIC-Vac, an international network of researchers who are developing human infection challenge studies to accelerate the development of vaccines against pathogens, and the Wellcome Trust, to generate regulatory style guidelines on the manufacture of human challenge agents for subsequent use in controlled human infection studies.
· This consortium aims to develop international standards that pertain to challenge agent manufacture and storage, extending the current general WHO guidelines relating to challenge studies.
· The consortium intends to create guidance fulfilling Good Manufacturing Practice (GMP) requirements to as much as is practically possible without necessarily being GMP certified, ‘GMP-like’ guidance. This will allow flexibility to manufacture challenge agents outside of GMP-certified premises, but with guidance to ensure safety, quality and consistency are maintained.
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, where possible, regulatory or advisory bodies (such as the WHO). There will also be wider engagement beyond the core consortium members with the specific intent of aiming to ensure its’ full applicability to all currently used challenge agents and its potential for wide adoption globally by local regulatory bodies and non-governmental institutions involved in the provision of guidance associated with CHIM studies. Learn more about the consortium at hvivo.com/aboutus/clinical-trial-consortium/
Cathal Friel, Executive Chairman of Open Orphan, said:
‘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. 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.”
Andrew Catchpole, Chief Scientific Officer, hVIVO, said:
“We are delighted to be collaborating with the members of the international consortium with specific input from low-to-Middle income countries (LMIC’s).
Today’s announcement shows the continued commitment of the infectious disease community in progressing designs and capabilities for research into bacteria, parasites and viruses.”
CHIM – controlled human infection studies are when a well-characterised strain of an infectious agent is given to carefully selected adult volunteers in order to better understand human diseases, how they spread, and find new ways to prevent and treat them. These studies play a vital role in helping to develop vaccines for infectious diseases.
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.