Zobrazeno 1 - 6
of 6
pro vyhledávání: '"Regina Kufer"'
Publikováno v:
mAbs, Vol 15, Iss 1 (2023)
ABSTRACTHost cell proteins (HCPs) are process-related impurities derived from the manufacturing of recombinant biotherapeutics. Residual HCP in drug products, ranging from 1 to 100 ppm (ng HCP/mg product) or even below sub-ppm level, may affect produ
Externí odkaz:
https://doaj.org/article/273decb2ae694d2098838e32ef9d9bf5
Autor:
Feng Yang, Delia Li, Regina Kufer, Lance Cadang, Jennifer Zhang, Lu Dai, Jia Guo, Stefanie Wohlrab, Midori Greenwood-Goodwin, Amy Shen, Dana Duan, Hong Li, Inn H. Yuk
Publikováno v:
Analytical Chemistry. 94:723-731
Residual host cell proteins (HCPs) in the drug product can affect product quality, stability, and/or safety. In particular, highly active hydrolytic enzymes at sub-ppm levels can negatively impact the shelf life of drug products but are challenging t
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9d84660b8b20b6464e3bfc2680f0a3b7
https://doi.org/10.1021/acs.analchem.1c03095
https://doi.org/10.1021/acs.analchem.1c03095
Autor:
Tobias Graf, Wenqiang Liu, Stefanie Wohlrab, Michael Leiss, Regina Kufer, Roberto Falkenstein, Bernhard Spensberger, Dana Duan, Franziska Edelmann, Inn H. Yuk, Anthony Tomlinson, Hong Li, Amy Shen
Publikováno v:
Journal of pharmaceutical sciences. 110(11)
Degradation of polysorbate (PS) by hydrolytically active host cell proteins (HCPs) in drug products may impair the protein-stabilizing properties of PS and lead to the formation of particles due to the accumulation of poorly soluble free fatty acids
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0df0806e6de58e763c65a9b6b7de6cf7
https://pubmed.ncbi.nlm.nih.gov/34224732
https://pubmed.ncbi.nlm.nih.gov/34224732
Publikováno v:
Analytical chemistry. 91(15)
Host cell proteins (HCPs) are the predominant class of impurities during manufacturing of therapeutic proteins. Previous reports have successfully shown that HCP characterization by LC-MS/MS ultimately leads to drug products of superior safety and qu
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ddd8236f818e83a7be2121993befa524
https://pubmed.ncbi.nlm.nih.gov/31260267
https://pubmed.ncbi.nlm.nih.gov/31260267
Publikováno v:
Molecular Biology of the Cell
Live-cell single-molecule imaging demonstrates that long-lasting telomerase–telomere interactions correspond to telomerase ribonucleoproteins that are engaged with the chromosome end. Furthermore, processive telomere elongation by telomerase is sho
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::822aa73228097082fc0603cf928e12f8
https://pubmed.ncbi.nlm.nih.gov/29386295
https://pubmed.ncbi.nlm.nih.gov/29386295
The reverse transcriptase telomerase adds telomeric repeats to chromosome ends to counteract telomere shortening and thereby assures genomic stability in dividing human cells. Key variables in telomere homeostasis are the frequency with which telomer
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e126a45be404e81156c27608a7b6ec7d
