Open AccessHuman infection studies: Key considerations for challenge agent development and production
Author(s) -
Shobana Balasingam,
Sarah Meillon,
Cecilia Chui,
Alex Mann,
Carine La,
Charlotte Weller,
Deborah King,
Emma Smith
Publication year - 2022
Publication title -
wellcome open research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.298
H-Index - 21
ISSN - 2398-502X
DOI - 10.12688/wellcomeopenres.17869.1
Subject(s) - good manufacturing practice , risk analysis (engineering) , production (economics) , quality (philosophy) , business , isolation (microbiology) , process (computing) , key (lock) , selection (genetic algorithm) , manufacturing process , process management , computer science , operations management , engineering , computer security , marketing , economics , biology , bioinformatics , supply chain , artificial intelligence , philosophy , materials science , epistemology , composite material , macroeconomics , operating system
Human infection (or challenge) studies involve the intentional administration of a pathogen (challenge agent) to volunteers. The selection, isolation, development and production of the challenge agent is one of the first steps in developing a challenge study and critical for minimising the risk to volunteers. Regulatory oversight for this production differs globally. Manufacturing agents within a Good Manufacturing Practice (GMP) facility reduces the risk of the manufacturing process by including processes such as confirming the identity of the challenge agent and ascertaining that it’s pure and free from impurities. However, in some cases it’s not possible or feasible to manufacture to GMP standards, for example where the challenge agent requires an intermediate vector for growth. There is lack of clear guidance on what the minimum requirements for high-quality safe manufacture outside of GMP facilities should be and here we describe the development of a considerations document for the selection and production of challenge agents to meet this need.