Mutagenic Impurities: Precompetitive/Competitive Collaborative and Data Sharing Initiatives

Precompetitive and competitive collaborations have flourished during the development of the ICH M7 guidelines (mutagenic impurities). The majority of these interactions are “honest broker” type arrangements, where an autonomous, independent third party is tasked with coordinating the activities of the consortium. Sometimes, more than one “honest broker” can be involved in the activity. Lhasa has been at the center of many of these collaborative initiatives; i.e., Derek Nexus Pharmaceutical Intermediates, Excipients, Zeneth, Mirabilis. The Product Quality Research Institute (PQRI) coordinated activities allowing a mechanistic understanding of the reaction mechanism for the formation of sulfonate esters, which after the Viracept withdrawal had been at the forefront of regulatory thinking. Other “not for profit” organizations that have played a role in the advancement of the greater understanding of mutagenic impurities include the various trade organizations, i.e., the Pharmaceutical Research and Manufactur...