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Manufacturing

Biomanufacturing

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Displaying 176 - 200 of 377

Qualification of NISTmAb charge heterogeneity control assays

March 18, 2018
Author(s)
Abigail Turner, John E. Schiel
The NISTmAb is a monoclonal antibody Reference Material from the National Institute of Standards and Technology; it is a class-representative IgG1κ intended serve as a pre-competitive platform for harmonization and technology development in the

The NISTmAb Tryptic Peptide Spectral Library for Monoclonal Antibody Characterization

March 6, 2018
Author(s)
Qian Dong, Yuxue Liang, Xinjian Yan, Sanford Markey, Yuri Mirokhin, Dmitrii V. Tchekhovskoi, Tallat H. Bukhari, Stephen E. Stein
We describe the creation of a mass spectral library composed of all identifiable spectra derived from the tryptic digest of a therapeutic monoclonal antibody. The NISTmAb library is a unique reference peptide spectral library developed from a total of six

Development of an LC-MS/MS peptide mapping protocol for the NISTmAb

March 1, 2018
Author(s)
Catherine A. Mouchahoir, John E. Schiel
Peptide mapping is a component of the analytical toolbox used within the biopharmaceutical industry to aid in the identity confirmation of a protein therapeutic and to monitor degradative events such as oxidation or deamidation. These methods offer the

Large Field of View Quantitative Phase Imaging of Induced Pluripotent Stem Cells and Optical Pathlength Reference Materials

February 23, 2018
Author(s)
Edward J. Kwee, Alexander W. Peterson, Jeffrey R. Stinson, Michael W. Halter, Liya Yu, Michael P. Majurski, Joe Chalfoun, Peter Bajcsy, John T. Elliott
Induced pluripotent stem cells (iPSCs) are reprogrammed cells that can have heterogeneous biological potential. Quality assurance metrics of reprogrammed iPSCs will be critical to ensure reliable use in cell therapies and personalized diagnostic tests. We

Protein Adsorption and Layer Formation at the Stainless Steel - Solution Interface Mediates Shear-Induced Particle Formation for an IgG1 Monoclonal Antibody

February 9, 2018
Author(s)
Cavan K. Kalonia, Frank Heinrich, Joseph E. Curtis, Sid Raman, Maria A. Miller, Steven Hudson
Passage of specific protein solutions through certain pumps, tubing, and/or filling nozzles can result in the production of unwanted subvisible protein particles (SVP). In this work, surface mediated SVP formation was investigated. Specifically, the

Effects of Distal Residues Mutations on the Structure, Dynamics and Catalysis of Human Monoacylglycerol Lipase

January 29, 2018
Author(s)
Sergiy Tyukhtenko, Girija Rajarshi, Ioannis Karageorgos, Nikolai Zvonok, Elyssia S. Gallagher, Hongwei Huang, Kiran Vemuri, Jeffrey W. Hudgens, Alexandros Makriyannis
An understanding of how conformational dynamics modulates function and catalysis of human monoacylglycerol lipase (hMGL), an important pharmaceutical target, can facilitate the development of novel modulatory ligands. Here, we report the discovery and

Tissue Inhibitor of Metalloprotease-2: bioprocess development, physicochemical, biochemical and biological characterization of highly expressed recombinant protein

December 1, 2017
Author(s)
Ananda Chowdhury, Robert G. Brinson, Beiyang Wei, William G. Stetler-Stevenson
Tissue Inhibitor of Metalloprotease -2 (TIMP-2) is a secreted, 21 kDa, multifunctional protein. It was first described as an endogenous inhibitor of matrix metalloproteases (MMPs) that prevents protease-mediated breakdown of the extracellular matrix often
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