Acceptable changes in quality attributes of glycosylated biopharmaceuticals

@article{Schiestl2011AcceptableCI,
  title={Acceptable changes in quality attributes of glycosylated biopharmaceuticals},
  author={Martin Schiestl and Thomas Stangler and Claudia Torella and Tadej {\vC}epeljnik and Hansj{\"o}rg Toll and Roger Grau},
  journal={Nature Biotechnology},
  year={2011},
  volume={29},
  pages={310-312}
}
To the Editor: Since the first marketing approvals of recombinant biopharmaceuticals, the question of which changes in quality attributes, which comprise identity, strength and purity, are acceptable in the life cycle of these products without changing the product label has been debated extensively1. This question is especially important in the context of manufacturing process changes, which happen quite frequently and for various reasons (e.g., process improvements, scale changes or site… CONTINUE READING
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