Business
Wellcome publication
Wellcome publication.
About this update from Hvivo Plc
[{"type":"text","content":"\n \n \n \n Open Orphan plc\n \n \n \n \n (\"Open Orphan\" or the \"Company\")\n \n \n \n \n \n \n \n Key considerations document for developing and manufacturing challenge agents published\n \n \n \n \n \n \n \n Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, notes a key considerations document for developing and manufacturing challenge agents published in the Wellcome Open Research Journal co-authored by Alex Mann, Senior Director of Clinical Research of hVIVOand the project lead, a subsidiary of Open Orphan plc, titled 'Considerations on the Principles of Development and Manufacturing Qualities of Challenge Agents For Use In Human Infection Models'.\n \n The project was funded by the Wellcome Trust and HIC-Vac, an international network of researchers who are developing human infection challenge (HIC) studies to accelerate the development of vaccines, based at Imperial College London. The considerations document was prepared by an hVIVO led consortium, involving engagement with global experts in the human challenge field and manufacturing. It outlines the key aspects of the development, characterisation and manufacture of infectious challenge agents. The aim of the document is to promote volunteer safety whilst maximising access to challenge agents and challenge models in low-income or middle-income countries (LMICs) and academic institutions globally.\n \n It is hoped that these considerations will be used across high-, middle- and low-income countries for the safe production of challenge agents by trained personnel with appropriate facilities, quality control measures and other best practices.\n \n The increase in human challenge studies being established in LMICs and the need for challenge agents to reflect naturally occurring and epidemiologically relevant pathogen strains means there is an increased likelihood that they will be manufactured in conditions where full Good Manufacturing Practice (\"GMP\") is not possible. This document fills the previous gap of clear guidance on the minimum requirements for high-quality and safe manufacture outside of GMP facilities.\n \n Challenge agents are the viruses, parasites, bacteria used...