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Search Publications by: Katharina Yandrofski (Fed)

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Displaying 1 - 7 of 7

Operationalizing Digital Twins in Biomanufacturing through Interoperable Process Analytical Technology

July 16, 2026
Author(s)
Abhijeet Satwekar, Cyndell Gracieux-Singleton, Veerabhadraiah Palakollu, Monica Acerbi, Ryan Barton, Chris Cummings, Allie Horton, Sandeep Kedia, Thomas Cornish, Katharina Yandrofski, Roger Hart, Dannielle Berlinghieri, James Saylor, Kelvin H. Lee
The integration of Process Analytical Technologies (PAT) within digital twin architectures represents a critical advancement in biopharmaceutical manufacturing. While existing literature has separately addressed digital twin dimensions, interoperability

NIST Biomanufacturing Reference Materials: Development, Applications and Impact

June 16, 2025
Author(s)
Katharina Yandrofski, Megan Cleveland, Zvi Kelman, Michael Tarlov, John Marino
Monoclonal antibody (mAb) therapeutics, currently the most successful platform class of biologic medicines, harness the naturally evolved specificity of adaptive immunity to treat a variety of conditions such as cancer, autoimmune disorders, and infectious

Recommended Nomenclature Convention for the NISTCHO Cell Line and Its Product Monoclonal Antibody, cNISTmAb.

April 11, 2025
Author(s)
Megan Cleveland, Ioannis Karageorgos, John Marino, Michael Tarlov, Katharina Yandrofski, Rebecca Zangmeister, Zvi Kelman
A Chinese hamster ovary (CHO) cell line expressing the same amino acid sequences of the heavy and light chains of the NIST monoclonal antibody, NISTmAb Reference Material 8671, was generated by MilliporeSigma to be developed by NIST as a reference material

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

Interlaboratory Studies using the NISTmAb to Advance Biopharmaceutical Structural Analytics

May 5, 2022
Author(s)
Katharina Yandrofski, Trina Mouchahoir, M. Lorna De Leoz, David L. Duewer, Jeffrey W. Hudgens, Kyle Anderson, Luke Arbogast, Frank Delaglio, Robert Brinson, John Marino, Karen W. Phinney, Michael J. Tarlov, John E. Schiel
Biopharmaceuticals such as monoclonal antibodies are required to be rigorously characterized using a wide range of analytical methods. Various material properties must be characterized and well controlled to assure that clinically relevant features and

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
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