Zobrazeno 1 - 10
of 36
pro vyhledávání: '"Nripen Singh"'
Publikováno v:
Journal of Pharmaceutical Sciences. 110:3535-3539
The buffering component selection is a key criterion for the formulation development process for biopharmaceuticals. This decision for recombinant adeno-associated virus (rAAV) mediated gene therapies is receiving special attention due to their rise
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fefd6fcf65cc292adc5dbdd3c8106568
https://doi.org/10.1016/j.xphs.2021.06.019
https://doi.org/10.1016/j.xphs.2021.06.019
Autor:
Xuankuo Xu, Nripen Singh, Zheng Jian Li, Steven J. Traylor, Ohnmar Khanal, Abraham M. Lenhoff, Sanchayita Ghose, Chao Huang
Publikováno v:
Journal of Membrane Science. :464-471
Depth filtration is a commonly-used bioprocessing unit operation for harvest clarification that reduces the levels of process- and product-related impurities such as cell debris, host-cell proteins, nucleic acids and protein aggregates. Since depth f
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d3348f85c44f9d2090fcb2f020c138f1
https://doi.org/10.1016/j.memsci.2018.10.058
https://doi.org/10.1016/j.memsci.2018.10.058
Autor:
Nripen Singh, Caryn L Heldt
Publikováno v:
Current Opinion in Chemical Engineering. 35:100780
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::741ae030432e7813e49d0b82382dbed3
https://doi.org/10.1016/j.coche.2021.100780
https://doi.org/10.1016/j.coche.2021.100780
Publikováno v:
Biotechnology Progress. 34:1137-1148
This work examines the ultrafiltration behavior of partially retained proteins like lysozyme and completely retained proteins like monoclonal antibodies using single pass tangential flow filtration (SPTFF) modules with different screen channels and m
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a3828760aa976e3ad3d5e9241c4662d3
https://doi.org/10.1002/btpr.2671
https://doi.org/10.1002/btpr.2671
Autor:
Joon Chong Yee, Nesredin Mussa, Zhijun Tan, Nripen Singh, Anthony J. Cura, Cheng Du, Zheng Jian Li, Ameya Borwankar, Michael C. Borys, Sanchayita Ghose, Yunping Huang, Richard Ludwig
Publikováno v:
mAbs. 10:500-510
During large-scale monoclonal antibody manufacturing, disulfide bond reduction of antibodies, which results in generation of low molecule weight species, is occasionally observed. When this happens, the drug substance does not meet specifications. Ma
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fb85c2823356f34025a9e79933da25e3
https://doi.org/10.1080/19420862.2018.1424609
https://doi.org/10.1080/19420862.2018.1424609
Autor:
Nripen Singh, Ameya Borwankar, Zheng Jian Li, Li Tao, Michael Borys, Jay A. A. West, Yunping Huang, Zhijun Tan, Robert Martin, Richard Ludwig, Cheng Du, Sanchayita Ghose
Publikováno v:
Biotechnology and Bioengineering. 115:900-909
Process control for manufacturing biologics is critical for ensuring product quality, safety, and lot to lot consistency of therapeutic proteins. In this study, we investigated the root cause of the pink coloration observed for various in-process poo
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::13cdc298f0d70c8c7d3bea9c8e03103f
https://doi.org/10.1002/bit.26511
https://doi.org/10.1002/bit.26511
Autor:
Deyu Yang, Andrew L. Zydney, Abhiram Arunkumar, Nripen Singh, Sanchayita Ghose, Youngbin Baek, Zheng Jian Li
Publikováno v:
Biotechnology Progress. 33:1555-1560
Diafiltration is used for final formulation of essentially all biotherapeutics. Several studies have demonstrated that buffer/excipient concentrations in the final diafiltered product can be different than that in the diafiltration buffer due to inte
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::315a9972e544065f8f2fe59310599d8c
https://doi.org/10.1002/btpr.2544
https://doi.org/10.1002/btpr.2544
Publikováno v:
Journal of Pharmaceutical Sciences. 106:1978-1986
We describe a noninvasive method developed to make in situ measurements of protein concentration in frozen drug substance. This technique is based on fluorescence from artificially labeled protein and a charge-coupled device camera. Data collected us
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bb4ff453b4ca9f8d9ea614eb024006d6
https://doi.org/10.1016/j.xphs.2017.04.047
https://doi.org/10.1016/j.xphs.2017.04.047
Autor:
Andrew L. Zydney, Nripen Singh, Zheng J. Li, Youngbin Baek, Michael C. Borys, Abhiram Arunkumar
Publikováno v:
Biotechnology and Bioengineering. 114:2057-2065
Ultrafiltration (UF) is used for the final concentration and formulation of essentially all antibody-based therapeutics including both monoclonal antibodies (mAbs) and Fc-fusion proteins. The objective of this study was to quantitatively compare the
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::e7104e45859e6e33425e947336b023c3
https://doi.org/10.1002/bit.26326
https://doi.org/10.1002/bit.26326
Publikováno v:
Journal of Membrane Science. 528:171-177
Fc-fusion proteins are an important new class of biotherapeutics; however, there is currently little published data on the behavior of these proteins in downstream processing operations. The objective of this study was to evaluate the ultrafiltration
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::afe8a8435785a464142187102435c45d
https://doi.org/10.1016/j.memsci.2017.01.029
https://doi.org/10.1016/j.memsci.2017.01.029