Zobrazeno 1 - 10
of 18
pro vyhledávání: '"Sambit R. Kar"'
Publikováno v:
Journal of Pharmaceutical Sciences. 110:3188-3199
Low pH virus inactivation (VI) step is routinely used in antibody production manufacturing. In this work, a mimic of the VI step was developed to focus on evaluating adverse effects on product quality. A commercially available lab-scale glass reactor
Autor:
Magfur E. Alam, Thomas R. Slaney, Peter M. Tessier, Sambit R. Kar, Tapan K. Das, Anthony Leone, Lina Wu, Gregory V. Barnett
Publikováno v:
Journal of Pharmaceutical Sciences. 109:656-669
Monoclonal antibodies are attractive therapeutic agents because of their impressive biological activities and favorable biophysical properties. Nevertheless, antibodies are susceptible to various types of chemical modifications, and the impact of suc
Autor:
Wasfi Al-Azzam, Sambit R. Kar, Niclas Chiang Tan, Zhenyu Gu, Zoran Sosic, Crystal Cicchino, Alexandru C. Lazar, Paul Weisbach, Yite Robert Chou, Liqiang Lisa Zhou, Jennifer Halley, Santosh V. Thakkar, Smith John M, Magdalena Gauden, Elaine S.E. Stokes, Min Huang, Promod Mehndiratta, Vikas K. Sharma, Stephane Cornen
Publikováno v:
Journal of Pharmaceutical Sciences. 109:6-21
The BioPhorum Development Group is an industry-wide consortium enabling networking and sharing of common practices for the development of biopharmaceuticals. Forced degradation studies (FDSs) are often used in biotherapeutic development to assess cri
Autor:
Franziska Schleinzer, Dennis T. Yang, Dean C. Ripple, Nazar Filonov, Pascal Chalus, Tapan K. Das, Kurt D. Benkstein, Ashwinkumar A. Bhirde, Stefan Romeijn, Fook Chiong Cheong, Sambit R. Kar, Laura A. Philips, Christine Probst, Adam D. Grabarek, Nicole S. Gill, Maciej Jarzebski, Yoen Joo Kim, David L. Duewer, Miguel Saggu, Andrew D. Hollingsworth, Gurusamy Balakrishnan, Judith Hadley, Vikram Kestens, Yannic Ramaye, Anja Matter, Wesley W. Howard, Theodore W. Randolph, Ngoc Do, Jan Kuba Tatarkiewicz, David G. Grier, Heather Anne Wright, Patrick Garidel, Atanas Koulov, Wim Jiskoot, Jared R. Snell, Harshit Khasa
Publikováno v:
J Pharm Sci
Journal of Pharmaceutical Sciences
Journal of Pharmaceutical Sciences
The measurement of polydisperse protein aggregates and particles in biotherapeutics remains a challenge, especially for particles with diameters of ≈ 1 µm and below (sub-micrometer). This paper describes an interlaboratory comparison with the goal
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ebec099deb60130fdbf19d1d6774ab17
https://europepmc.org/articles/PMC9912188/
https://europepmc.org/articles/PMC9912188/
Autor:
Sambit R. Kar, Tapan K. Das, Xue Li, Sudhakar Voruganti, Jiahui Xu, Surinder M. Singh, Gurusamy Balakrishnan
Publikováno v:
Journal of pharmaceutical sciences. 110(2)
N-linked glycosylation is an important post translational modification that occurs on Asparagine 297 residue or a homologous position on the Fc portion of monoclonal antibodies (mAbs). mAb Fc glycans play important roles in antibody structure, stabil
Publikováno v:
Analytical Chemistry. 90:6959-6966
Methionine oxidation is a major degradation pathway in therapeutic proteins which can impact the structure and function of proteins as well as risk to drug product quality. Detecting Met oxidation in proteins by peptide mapping followed by liquid chr
Autor:
Dean C. Ripple, Karoline Bechtold-Peters, Rukman De Silva, E. Neil Lewis, Anja Matter, Olga Laskina, Linda O. Narhi, Roman Mathaes, Richard E. Cavicchi, John F. Carpenter, Sophia Kenrick, Ellen Koepf, Andrea Hawe, Sambit R. Kar
Publikováno v:
The AAPS journal. 22(1)
The phase-appropriate application of analytical methods to characterize, monitor, and control particles is an important aspect of the development of safe and efficacious biotherapeutics. The AAPS Product Attribute and Biological Consequences (PABC) f
Autor:
Surinder M. Singh, Julia Ding, Jeff Beckman, Rekha Tulsan, Zheng Jian Li, Ryan Knihtila, Jennifer Atsma, Sambit R. Kar, Qian Guan
Publikováno v:
Journal of Chromatography B. 1152:122230
Capillary gel electrophoresis (CGE) using sodium dodecyl sulfate (CGE-SDS or CE-SDS) is commonly used in the biotechnology industry to assess the purity of a complex therapeutic during manufacturing process optimization and also for commercial releas
Autor:
Tapan K. Das, Thomas R. Slaney, Yunping Huang, Sambit R. Kar, Anthony Leone, Gurusamy Balakrishnan, Li Tao, Gregory V. Barnett, Laurel Hoffman, Jacob Bongers, Naresh Chennamsetty
Publikováno v:
Journal of pharmaceutical sciences. 108(6)
Tryptophan (Trp) oxidation in proteins leads to a number of events, including changes in color, higher order structure (HOS), and biological activity. We describe here a number of new findings through a comprehensive characterization of 6 monoclonal
Publikováno v:
Pharmaceutical Research. 35
Characterizing submicron protein particles (approximately 0.1–1μm) is challenging due to a limited number of suitable instruments capable of monitoring a relatively large continuum of particle size and concentration. In this work, we report for th