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Search Publications by: Srivalli Telikepalli (Fed)

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Displaying 1 - 10 of 10

Humanized Monoclonal Antibody IgG1k, NISTmAb RM 8671 Summary of 5 Year Stability Verification (5YSV)

March 31, 2023
Author(s)
Katharina Yandrofski, John E. Schiel, Trina Mouchahoir, Srivalli Telikepalli, N. Alan Heckert, Dean C. Ripple, Paul C. DeRose, Karen W. Phinney, John Marino
NISTmAb RM 8671 is an IgG1κ monoclonal antibody that has been extensively characterized and released as the first of its kind biopharmaceutical reference material in 2016. This material was intended primarily for use in evaluating the performance of

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

Filling the Pharmacopeial Gaps of Visual Inspection Toward Standardization and Consistency of Visible Particle Testing

May 3, 2021
Author(s)
Linda Narhi, George M. Bou-Assaf, Kristen Gonzalez, Maryam Mazaheri, Steven Messick, Srivalli Telikepalli
The presence of visible particles that are not anticipated to be present in drug products is one of the most common causes of recalls, and warning letters1, 2. This critical quality attribute, which is typically determined during visual inspection (along

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

The NISTmAb Reference Material 8671 Value Assignment, Homogeneity, and Stability

March 1, 2018
Author(s)
John E. Schiel, Abigail Turner, Catherine A. Mouchahoir, Katharina S. Yandrofski, Srivalli Telikepalli, Jason King, Paul C. DeRose, Dean C. Ripple, Karen W. Phinney
The NISTmAb Reference Material (RM) 8671 is intended to be the common industry standard monoclonal antibody for pre-competitive research in harmonizing current state-of-the-art technology and designing next generation characterization technologies for

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