Publications by authors named "Krishnan Sampathkumar"

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Analytical control strategy for biologics. Part II: Roadmap for development and implementation.
Krishnan Sampathkumar, Brent S Kendrick, John P Gabrielson, Da Ren

J Pharm Sci· August 2025

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Analytical control strategy for biologics. Part I: Foundations.
Brent S Kendrick, Krishnan Sampathkumar, John P Gabrielson, Da Ren

J Pharm Sci· July 2025

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Roadmap for Drug Product Development and Manufacturing of Biologics.
Krishnan Sampathkumar, Bruce A Kerwin

J Pharm Sci· February 2024

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Rational design of lyophilized high concentration protein formulations-mitigating the challenge of slow reconstitution with multidisciplinary strategies.
Wenjin Cao, Sampathkumar Krishnan, Margaret Speed Ricci, Liang-Yu Shih, Dingjiang Liu

Eur J Pharm Biopharm· October 2013

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Effect of pH and excipients on structure, dynamics, and long-term stability of a model IgG1 monoclonal antibody upon freeze-drying.
Jihea Park, Karthik Nagapudi, Camille Vergara, Ranjini Ramachander, Jennifer S Laurence, Sampathkumar Krishnan

Pharm Res· April 2013

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IgG1 aggregation and particle formation induced by silicone-water interfaces on siliconized borosilicate glass beads: a model for siliconized primary containers.
Pinaki Basu, Sampathkumar Krishnan, Renuka Thirumangalathu, Theodore W Randolph, John F Carpenter

J Pharm Sci· March 2013

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Influence of process conditions on the crystallization and transition of metastable mannitol forms in protein formulations during lyophilization.
Wenjin Cao, Yong Xie, Sampathkumar Krishnan, Hong Lin, Margaret Ricci

Pharm Res· January 2013

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Development of stable lyophilized protein drug products.
Richard L Remmele, Sampathkumar Krishnan, William J Callahan

Curr Pharm Biotechnol· March 2012

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Elucidation of degradants in acidic peak of cation exchange chromatography in an IgG1 monoclonal antibody formed on long-term storage in a liquid formulation.
Sejal Gandhi, Da Ren, Gang Xiao, Pavel Bondarenko, Christopher Sloey, Sampathkumar Krishnan

Pharm Res· January 2012

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Silicone oil- and agitation-induced aggregation of a monoclonal antibody in aqueous solution.
Renuka Thirumangalathu, Sampathkumar Krishnan, Margaret Speed Ricci, David N Brems, Theodore W Randolph

J Pharm Sci· September 2009

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Multistep aggregation pathway of human interleukin-1 receptor antagonist: kinetic, structural, and morphological characterization.
Sampathkumar Krishnan, Andrei A Raibekas

Biophys J· January 2009

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Characterization of mannitol polymorphic forms in lyophilized protein formulations using a multivariate curve resolution (MCR)-based Raman spectroscopic method.
Yong Xie, Wenjin Cao, Sampathkumar Krishnan, Hong Lin, Nina Cauchon

Pharm Res· October 2008

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Oxidation of methionine residues in recombinant human interleukin-1 receptor antagonist: implications of conformational stability on protein oxidation kinetics.
Renuka Thirumangalathu, Sampathkumar Krishnan, Pavel Bondarenko, Margaret Speed-Ricci, Theodore W Randolph

Biochemistry· May 2007

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Differentiation and quantitative determination of surface and hydrate water in lyophilized mannitol using NIR spectroscopy.
Wenjin Cao, Chen Mao, Wendy Chen, Hong Lin, Sampathkumar Krishnan

J Pharm Sci· September 2006

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Effects of pH, temperature, and sucrose on benzyl alcohol-induced aggregation of recombinant human granulocyte colony stimulating factor.
Renuka Thirumangalathu, Sampathkumar Krishnan, David N Brems, Theodore W Randolph, John F Carpenter

J Pharm Sci· July 2006

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Active dimer of Epratuzumab provides insight into the complex nature of an antibody aggregate.
Richard L Remmele, William J Callahan, Sampathkumar Krishnan, Linda Zhou, Pavel V Bondarenko

J Pharm Sci· January 2006

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Mechanism for benzyl alcohol-induced aggregation of recombinant human interleukin-1 receptor antagonist in aqueous solution.
Ye Zhang, Shouvik Roy, Latoya S Jones, Sampathkumar Krishnan, Bruce A Kerwin

J Pharm Sci· December 2004

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Optimizing storage stability of lyophilized recombinant human interleukin-11 with disaccharide/hydroxyethyl starch mixtures.
William Garzon-Rodriguez, Rebecca L Koval, Suchart Chongprasert, Sampathkumar Krishnan, Theodore W Randolph

J Pharm Sci· March 2004

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Physical stability of proteins in aqueous solution: mechanism and driving forces in nonnative protein aggregation.
Eva Y Chi, Sampathkumar Krishnan, Theodore W Randolph, John F Carpenter

Pharm Res· September 2003

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Roles of conformational stability and colloidal stability in the aggregation of recombinant human granulocyte colony-stimulating factor.
Eva Y Chi, Sampathkumar Krishnan, Brent S Kendrick, Byeong S Chang, John F Carpenter

Protein Sci· May 2003

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Oxidative dimer formation is the critical rate-limiting step for Parkinson's disease alpha-synuclein fibrillogenesis.
Sampathkumar Krishnan, Eva Y Chi, Stephen J Wood, Brent S Kendrick, Cynthia Li

Biochemistry· January 2003

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Aggregation of granulocyte colony stimulating factor under physiological conditions: characterization and thermodynamic inhibition.
Sampathkumar Krishnan, Eva Y Chi, Jonathan N Webb, Byeong S Chang, Daxian Shan

Biochemistry· May 2002

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