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Search Publications by: Michael J. Carrier (Fed)

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Displaying 1 - 16 of 16

An Interlaboratory Study of Potential Visible Protein-Like Particle Standards

November 1, 2022
Author(s)
Srivalli Telikepalli, Michael J. Carrier, Dean C. Ripple
Visible protein-like particle standards can improve visual inspection and/or appearance testing practices used in the biotechnology industry. It will improve assay performance resulting in better alignment and more standardized training among different

Testing Precision Limits of Neural Network-Based Quality Control Metrics in High-Throughput Digital Microscopy

January 26, 2022
Author(s)
Chris Calderon, Dean C. Ripple, Charudharshini Srinivasan, Youlong Ma, Michael J. Carrier, Theodore Randolph, Thomas O'Connor
Digital microscopy is used to monitor particulates such as protein aggregates within biologic pharmaceutical products. The digital images that result encode a wealth of information, but much of this image data is underutilized in pharmaceutical process

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

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

Reference Material 8634: Ethylene Tetrafluoroethylene for Particle Size Distribution and Morphology

May 1, 2019
Author(s)
Dean C. Ripple, Srivalli Telikepalli, Kristen L. Steffens, Michael J. Carrier, Christopher B. Montgomery, Nicholas W. Ritchie, John Lu
Reference Material (RM) 8634 is a NIST particle standard produced from abraded ethylene tetrafluoroethylene (ETFE), a chemically inert polymer, that will help standardize and allow more accurate monitoring of subvisible proteinaceous particles in

Initiation of flash boiling of multicomponent miscible mixtures with application to transportation fuels and their surrogates

August 16, 2018
Author(s)
Charles T. Avedisian, Kyle Skyllingstad1, Richard E. Cavicchi, Corinne Lippe, Michael J. Carrier
This paper presents methodologies to predict thermodynamic conditions that initiate flash boiling by spontaneous nucleation of liquids consisting of hundreds of miscible liquids and their lower order surrogate mixtures. The methods are illustrated with a

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

Rapid evaporation at the superheat limit of methanol, ethanol, butanol and n-heptane on platinum films supported by low-stress SiN membranes

June 7, 2016
Author(s)
Eric J. Ching, C. T. Avedisian, Richard E. Cavicchi, Do H. Chung, Jeff Rah, Michael J. Carrier
The bubble nucleation temperatures of several organic liquids (methanol, ethanol, butanol,n-heptane) on stress-minimized platinum (Pt) films supported by SiN membranes is examined by pulse-heating the membranes for times ranging from 1 υs to 10 υs. The

Bubble Nucleation of Highly Superheated Water on Thin Film Platinum Films supported by SiN Membranes using a Low-Noise Bridge Circuit

December 1, 2014
Author(s)
Eric J. Ching, Michael J. Carrier, C. T. Avedisian, James R. Young, Bruce R. Land, Richard E. Cavicchi
This study describes the use of stress-minimized thin film platinum (Pt) membrane configurations (200 nm thick, 150 μm long, 10 μm wide) for promoting bubble nucleation of water near its superheat limit. The membrane designs consist of Pt films deposited

The Metrology of Counting Protein Particles

July 13, 2013
Author(s)
Dean C. Ripple, Michael J. Carrier, Richard E. Cavicchi, Christopher B. Montgomery, Zhishang Hu
A common degradation pathway for protein-based drugs is the growth of protein aggregates or particles. Counting and characterization of these particles is needed to assure the quality, efficacy, and safety of this type of drug. The unusual physical

The Metrology of Counting Protein Particles

March 18, 2013
Author(s)
Dean C. Ripple, Michael J. Carrier, Richard E. Cavicchi, Christopher B. Montgomery, Zhishang Hu
A common degradation pathway for protein-based drugs is the growth of protein aggregates or particles. Counting and characterization of these particles is needed to assure the quality, efficacy, and safety of this type of drug. The unusual physical

Standards for the Optical Detection of Protein Particulates

January 23, 2012
Author(s)
Dean C. Ripple, Michael J. Carrier, Joshua R. Wayment
Particulates in protein therapeutics, composed of agglomerated protein monomers, may cause an immunogenic response in patients. Consequently, industry and the FDA desire more accurate methods for counting and characterizing particulates. Unlike likely

Structure and Properties of Silica Nanoclusters at High Temperatures

June 1, 2002
Author(s)
I V. Schweigert, K E. Lehtinen, Michael J. Carrier, Michael R. Zachariah
The properties of silica clusters at temperatures from 1500 to 2800 K are investigated using classical molecular dynamics simulations for particles containing up to 1152 atoms. We found that atoms in the cluster were arranged in a shell-like structure at