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Displaying 26 - 50 of 160

Development of Orthogonal NISTmAb Size Heterogeneity Control Methods

February 10, 2018
Author(s)
Abigail Turner, Katharina S. Yandrofski, Srivalli Telikepalli, N. Alan Heckert, James J. Filliben, Dean C. Ripple, John E. Schiel
The NISTmAb is an innovative monoclonal antibody reference material from the National Institute of Standards and Technology; it is a class-representative IgG1κ intended to serve as a pre-competitive platform for harmonization and technology development in

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

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

SRM 1967a: High-Purity Platinum Thermoelement

March 9, 2016
Author(s)
Karen M. Garrity, Weston L. Tew, Dean C. Ripple
Consisting of a 1 m long piece of 0.5 mm diameter platinum wire, SRM 1967a meets the requirements for a thermoelectric reference material for temperatures from 196 °C up to approximately 1700 °C. We have tested the thermoelectric emf of four SRM 1967a

Protein Particles (0.1 ym to 100 ym)

October 15, 2015
Author(s)
Dean C. Ripple, Linda Narhi
Protein molecules in solution can form proteinaceous particles by a variety of aggregation processes. The size and concentration of these particles is an important quality attribute for therapeutic MAb solutions. In this chapter, we describe the techniques

Sub-visible (2 mm to 100 mm) particle analysis during biotherapeutic drug product development: Part 1, considerations and strategy

April 1, 2015
Author(s)
Dean C. Ripple, Linda Narhi, Natliya Afonina, Satish Singh, Andrea Herre, Patrick Garidel, Atanas Koulov, Vincent Corvari, Thomas Spitznagel, Paolo Mangiagalli, Irene Cecchini, Klaus Wuchner, Tony Lubiniecki, Hanns-Christian Mahler, Roland Schmidt, Alla Polozova, Patricia Cash, Andrew Weiskopf, Douglas Nesta, Mara Rossi, Robert Simler
Measurement and characterization of particles in the 1 µm to 100 µm range (sub-visible particles), including protein aggregates, is an important part of every stage of protein therapeutic development. The tools used and the ways in which the information

The Use of Index-Matched Beads in Optical Particle Counters

January 8, 2015
Author(s)
Dean C. Ripple
Although multiple methods are available for counting and sizing of protein particles over a broad range of sizes, differences in physical properties between common polystyrene-bead reference materials and the actual protein particles of interest result in