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A standard established by the United States Pharmacopeial Convention (USP), USP chapter <787>, Subvisible Particulate Matter in Therapeutic Protein Injections, became official August 1, 2014.
It requires pharmaceutical and biopharmaceutical manufacturers making injections and infusions to follow rigorous rules regarding the quantity of particles present in final drug products. This regulation focuses specifically on the development of more costly protein formulations and the unique sensitivities inherent in producing protein-based therapeutics.
Chapter <787> evolved to address the limitations of USP for therapeutic proteins and provides a smaller-volume testing framework to address proteinaceous particles and the immunological effects of a sub-10-µm particle load.