Identification and characterization of a residual host cell protein hexosaminidase B associated with N ‐glycan degradation during the stability study of a therapeutic recombinant monoclonal antibody product-Reference-Cited by-同舟云学术

Identification and characterization of a residual host cell protein hexosaminidase B associated with N ‐glycan degradation during the stability study of a therapeutic recombinant monoclonal antibody product

Published:2021-03-12 Issue:3 Volume:37 Page:
ISSN:8756-7938
Container-title:Biotechnology Progress
language:en
Short-container-title:Biotechnol Progress

Author:

Li Xuanwen¹^ORCID,An Yan²,Liao Jing¹,Xiao Li³,Swanson Michael⁴,Martinez‐Fonts Kirby²,Pavon Jorge Alexander²,Sherer Edward C.³,Jawa Vibha⁴,Wang Fengqiang²,Gao Xinliu¹,Letarte Simon¹,Richardson Douglas D.¹

Affiliation:

1. Analytical Research & Development Mass Spectrometry, Merck & Co., Inc. Kenilworth New Jersey USA

2. Biologics Analytical Research & Development, Merck & Co., Inc. Kenilworth New Jersey USA

3. Computational and Structural Chemistry, Merck & Co., Inc. Kenilworth New Jersey USA

4. Predictive and Clinical Immunogenicity, Merck & Co., Inc. Kenilworth New Jersey USA

Publisher

Wiley

Subject

Biotechnology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/btpr.3128

Reference25 articles.

1. Experience with host cell protein impurities in biopharmaceuticals

2. The future of host cell protein (HCP) identification during process development and manufacturing linked to a risk‐based management for their control

3. Specific Immune Response to Phospholipase B-Like 2 Protein, a Host Cell Impurity in Lebrikizumab Clinical Material

4. Polysorbates 20 and 80 Degradation by Group XV Lysosomal Phospholipase A 2 Isomer X1 in Monoclonal Antibody Formulations

5. Knockout of a difficult‐to‐remove CHO host cell protein, lipoprotein lipase, for improved polysorbate stability in monoclonal antibody formulations

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