Identification of Low-Level Product-Related Variants in Filgrastim Products Presently Available in Highly Regulated Markets.

Anna HausbergerWilliam C LamannaMartin HartingerAndreas SeidlHansjoerg TollJohann Holzmann

Published in: BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy (2017)

This study demonstrates that filgrastim products already in widespread clinical use in highly regulated markets differ in low-level, product-related variants present at levels mostly below 1 % relative abundance. This study provides a comprehensive catalog of minor differences between filgrastim products and suggests that the filgrastim product-related variants described here are not clinically relevant when present at low abundance.

Keyphrases

copy number
transcription factor
wastewater treatment