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Manufacturing

Biomanufacturing

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Displaying 101 - 125 of 198

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

The role of human monoacylglycerol lipase (hMAGL) binding pocket in breakup of unsaturated phospholipid membranes

November 1, 2017
Author(s)
Ioannis L. Karageorgos, Vitalii I. Silin, nikolai zvonok, John P. Marino, David Janero, Alexandros Makriyannis
Human monoacylglycerol lipase (hMAGL) plays a key role in homeostatic tuning of the endocannabinoid signaling system and supports aggressive tumorogenesis, making this enzyme a promising therapeutic target. hMAGL features a membrane-associated lid domain

Non-Uniform Sampling for All: More Spectral Quality, Less Measurement Time

June 30, 2017
Author(s)
Frank Delaglio, Gregory S. Walker, Kathleen A. Farley, Raman Sharma, Jeffrey C. Hoch, Luke Arbogast, Robert Brinson, John Marino
Nuclear Magnetic Resonance (NMR) spectroscopy is an indispensable tool in pharmaceutical science, with uses in drug discovery, development, and manufacturing. Non-Uniform Sampling (NUS) is an acquisition method for NMR experiments with two or more

FDA Approves First Genetically-Modified Cell Therapy to Treat Leukemia

March 1, 2017
Author(s)
Carl Simon Jr.
The FDA approved the first genetically-modified cell therapy for the treatment of leukemia on August 30, 2017 [1-2]. The treatment (tisagenlecleucel) is an "autologous genetically modified immunocellular therapy indicated for the treatment of pediatric and

Variable Threshold Method for Determining the Boundaries of Imaged Subvisible Particles

February 15, 2017
Author(s)
Richard E. Cavicchi, Cayla Collett, Srivalli Telikepalli, Zhishang Hu, Michael J. Carrier, Dean C. Ripple
An accurate assessment of particle characteristics and concentrations in pharmaceutical products by flow imaging requires accurate particle sizing and morphological analysis. Analysis of images begins with the definition of particle boundaries from the

A new approach to quantification of mAb aggregates using peptide affinity probes

February 10, 2017
Author(s)
Crystal Cheung, Kyle Anderson, Pooja Patel, Keale Cade, Karen W. Phinney, Illarion Turko
Using mAbs as therapeutic molecules is complicated by the propensity of mAbs to aggregate at elevated concentrations, which can lead to a variety of adverse events in treatment. Here, we describe a proof-of-concept for new methodology to detect and

Application of 2D-NMR with Room Temperature NMR Probes for the Assessment of the Higher Order Structure of Filgrastim

January 15, 2017
Author(s)
Robert G. Brinson, Houman Ghasriani, Derek Hodgson, Adams Kristie, Ian McEwen, Kang Chen, Yves Aubin, John P. Marino
The higher order structure (HOS) of biotherapeutics is a critical quality attribute that can be evaluated by nuclear magnetic resonance (NMR) spectroscopy at atomic resolution. NMR spectral mapping of HOS can be used to establish HOS consistency of a

Analytical Gaps and Challenges for Particles in the Submicrometer Size Domain

November 30, 2016
Author(s)
Scott Aldrich, Shawn Cao, Andrea Hawe, Desmond Hunt, Linda Narhi, Dean C. Ripple, Satish Singh
This Stimuli article provides a technical discussion of the available technologies for submicrometer particle analysis, including consideration of the advantages, disadvantages, and technical gaps for each application. These methods can be used in the
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