<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Isabelle Bekeredjian-Ding</style></author><author><style face="normal" font="default" size="100%">Jean-Hugues Trouvin</style></author><author><style face="normal" font="default" size="100%">Hilde Depraetere</style></author><author><style face="normal" font="default" size="100%">Carine La</style></author><author><style face="normal" font="default" size="100%">Akamol E Suvarnapunya</style></author><author><style face="normal" font="default" size="100%">Alan Bell</style></author><author><style face="normal" font="default" size="100%">Alex Mann</style></author><author><style face="normal" font="default" size="100%">Pauline Meij</style></author><author><style face="normal" font="default" size="100%">Jeffrey M Bethony</style></author><author><style face="normal" font="default" size="100%">Linda Schellhaas</style></author><author><style face="normal" font="default" size="100%">Nazziwa, Winfred Badanga</style></author><author><style face="normal" font="default" size="100%">Eric Karikari-Boateng</style></author><author><style face="normal" font="default" size="100%">Prachumsri, Jetsumon Sattabongkot</style></author><author><style face="normal" font="default" size="100%">Paula Salmikangas</style></author><author><style face="normal" font="default" size="100%">Dean Smith</style></author><author><style face="normal" font="default" size="100%">Peter Stjärnkvist</style></author><author><style face="normal" font="default" size="100%">Wim Van Molle</style></author><author><style face="normal" font="default" size="100%">Marc Baay</style></author><author><style face="normal" font="default" size="100%">Neels, Pieter</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain.</style></title><secondary-title><style face="normal" font="default" size="100%">Biologicals</style></secondary-title></titles><dates><year><style  face="normal" font="default" size="100%">2021</style></year><pub-dates><date><style  face="normal" font="default" size="100%">2021 Nov</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">74</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;There is an increasing need to establish quality principles for designing, developing and manufacturing challenge agents as currently these agents are classified differently by various jurisdictions. Indeed, considerations for challenge agent manufacturing vary between countries due to differences in regulatory oversight, the categorization of the challenge agent and incorporation into medicinal/vaccine development processes. To this end, a whitepaper on the guidance has been produced and disseminated for consultation to researchers, regulatory experts and regulatory or advisory bodies. This document is intended to discuss fundamental principles of selection, characterization, manufacture, quality control and storage of challenge agents for international reference. In the development phase, CMC documentation is needed for a candidate challenge agent, while standard operating procedure documentation is needed to monitor and control the manufacturing process, followed by use of qualified methods to test critical steps in the manufacturing process, or the final product itself. These activities are complementary: GMP rules, which intervene only at the time of the routine manufacturing of batches, do not contribute to the proper development and qualification of the candidate product. Some considerations regarding suitability of premises for challenge manufacturing was discussed in the presentation dedicated to &quot;routine manufacturing&quot;.&lt;/p&gt;
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