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pro vyhledávání: '"Rob E. Warburton"'
Autor:
Robert W. Phelan, Michael R. De Felippis, Dayue Chen, Marie Murphy, Kelly R. Smith, Jay S. Bolden, Rob E. Warburton
Publikováno v:
Biologicals. 44:434-440
A phenomenon initially reported by Chen and Vinther in 2013 [1], and now commonly referred to as low endotoxin recovery (LER), has prompted the Food and Drug Administration (FDA) to request specific data demonstrating the capability of the LAL BET me
Autor:
Matthew K. Miner, Kelly R. Smith, Mark Eugene Claerbout, Marie Murphy, Jay S. Bolden, Rob E. Warburton
Publikováno v:
PDA journal of pharmaceutical science and technology. 68(5)
The inability to detect endotoxin using compendia methods is a potential safety concern for patients due to the lack of endotoxin removal capabilities at the fill–finish stage in typical aseptic biologic drug product manufacturing. We have successf