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Biotechnol Bioeng April 2023 PMID 36585356

Characterization and implications of host-cell protein aggregates in biopharmaceutical processing.

Young Hoon Oh, Matthew L Becker, Kerri M Mendola, Leila H Choe, Lie Min, Kelvin H Lee, Yinges Yigzaw, Alexander Seay, Jerome Bill, Xuanwen Li, David J Roush, Steven M Cramer, Stefano Menegatti, Abraham M Lenhoff

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Abstract in brief

  • The study finds that host cell protein (HCP) aggregates, which may not originate from chromatinderived sources, can significantly contribute to the persistence of HCPs in biopharmaceutical processes, potentially affecting product stability and safety.
  • These aggregates can interfere with current detection methods, making it harder to accurately identify and remove HCPs, especially those involved in processes like the unfolded protein response (UPR) such as chaperones.
  • Understanding the formation and behavior of these HCP aggregates can help improve purification techniques, leading to safer and more effective biopharmaceutical products.]
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