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Manufacturing

Biomanufacturing

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Displaying 126 - 150 of 377

Strategies for Development of a Next-Generation Protein Sequencing Platform

January 1, 2020
Author(s)
Nicholas Callahan, Jennifer A. Tullman, John Marino, Zvi Kelman
Proteomic analysis can be a critical bottleneck in cellular characterization. The current paradigm relies primarily on mass spectrometry of peptides and affinity reagents (i.e. antibodies), both of which require a priori knowledge of the sample. A non

Establishing Standards and Methods for Qualification and Validation of New Particle Measurement Technologies

November 12, 2019
Author(s)
Srivalli Telikepalli, Dean C. Ripple, Kurt D. Benkstein, Kristen L. Steffens, Michael J. Carrier, Christopher B. Montgomery
Numerous particle sizing and counting methods exist for measuring particles in the submicrometer, subvisible, and visible size range. This article will briefly describe some key aspects that need to be considered for the most commonly used methods in order

Selective spin inversion in solution by magic field cross polarization

November 1, 2019
Author(s)
Joel Tolman, Luke Arbogast
A pulsed element is proposed allowing the selective inversion of a single 1H nucleus, without regard to the presence of other degenerate 1H nuclei, provided that it is coupled to a heteronuclear spin with adequate chemical shift resolution in a 2D

Phase-Appropriate Application of Analytical Methods to Monitor Subvisible Particles Across the Biotherapeutic Drug Product Life Cycle

October 30, 2019
Author(s)
Roman Mathaes, Linda Narhi, Andrea Hawe, Anja Matter, Karoline Bechtold-Peters, Sophia Kenrick, Sambit Kar, Olga Laskina, John Carpenter, Richard E. Cavicchi, Ellen Koepf, Neil Lewis, Rukman De Sliva, Dean C. Ripple
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) focus

Development of Protein-Like Reference Material for Semi-Quantitatively Monitoring Visible Proteinaceous Particles in Biotherapeutics

June 17, 2019
Author(s)
Srivalli Telikepalli, Kristen Gonzalez, Sonia Dragulin-Otto, Dean C. Ripple, Michael J. Carrier, M Khan
Visual inspection of biotherapeutics is required at various stages of drug production and manufacturing to ensure quality and consistency of drug products. Inherent particles, composed of aggregated protein from the drug-product, may potentially pose

Hydrogen-Deuterium Exchange Mass Spectrometry (HDX-MS) Centroid Data Measured between 3.6 degC and 25.4 degC for the Fab Fragment of NISTmAb

May 2, 2019
Author(s)
Jeffrey W. Hudgens, Elyssia S. Gallagher, Ioannis L. Karageorgos, Kyle W. Anderson, Richard Y. Huang, Guodong Chen, George M. Bou-Assaf, Alfonso Espada, Michael J. Chalmers, Edu Harguindey, Hui-Min Zhang, Benjamin T. Walters, Jennifer Zhang, John Venable, Caitlin Steckler, In Hee Park, Ansgar Brock, Xiaojun Lu, Ratnesh Pandey, Arun Chandramohan, Ganesh Srinivasan Anand, Sasidhar N. Nirudodhi, Justin Sperry, Jason C. Rouse, James A. Carroll, Kasper D. Rand, Ulrike Leurs, David D. Weis, Mohammed A. Al-Naqshabandi, Daniel Deredge, Patrick Wintrode, Malvina Papanastasiou, John D. Lambris, Sheng Li, Sarah Urata
The spreadsheet file reported herein provides centroid data, descriptive of deuterium uptake, for the Fab Fragment of NISTmAb (PDB: 5K8A) reference material, as measured by the bottom-up hydrogen-deuterium exchange mass spectrometry (HDX-MS) method. The
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