U.S. flag

An official website of the United States government

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS
A lock ( ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

Manufacturing

Biomanufacturing

Search Publications

Search Title, Abstract, Conference, Citation, Keyword or Author
  • Published Date
Displaying 126 - 150 of 199

Rheology of clustering protein solutions

July 5, 2016
Author(s)
Vishnu Dharmaraj, P. Douglas Godfrin, Yun Liu, Steven Hudson
High viscosity is a major challenge with protein therapeutics at extremely high concentration. Understanding the relationship between the concentration of a protein solution and its viscosity as a function of shear rate and temperature is therefore

Strategies for Achieving Measurement Assurance for Cell Therapy Products

June 1, 2016
Author(s)
Carl G. Simon Jr., Anne L. Plant, Sumona Sarkar, John T. Elliott, Sheng Lin-Gibson
Cell therapy products (CTPs) need quantitative, validated, and robust assays to support informed decision making during their development, manufacturing, and regulation. These products, the materials involved in their production and the methods for

Large-scale Time-lapse Microscopy of Oct4 Expression in Human Embryonic Stem Cell Colonies

May 22, 2016
Author(s)
Kiran Bhadriraju, Michael Halter, Julien M. Amelot, Peter Bajcsy, Joe Chalfoun, Antoine Vandecreme, Barbara Mallon, Kye-yoon Park, John T. Elliott, Subhash Sista, Anne L. Plant
Identification of critical characteristics of therapeutically active cells, and quantification of those characteristics, are essential for assuring consistency and potency of cell therapy products. We have developed image analysis and visualization

3D Segmentation of Stem Cells from Thousands of Confocal Microscopy Images

March 1, 2016
Author(s)
Peter Bajcsy, Mylene H. Simon, Stephen J. Florczyk, Carl G. Simon Jr., Derek Juba, Mary C. Brady
We address the problem of estimating 3D segmentation performance when segmentation is applied to thousands of confocal microscopy images (z-stacks) of cells. With a very large number of z-stacks, manual inputs to validate each segmentation result are

Method Validation and Standards in Hydrogen/Deuterium Exchange Mass Spectrometry

March 1, 2016
Author(s)
Jeffrey W. Hudgens, Richard Y. Huang, Emma D'Ambro
The chapter examines method validation and measurement standards for measuring protein dynamics by hydrogen/deuterium exchange mass spectrometry. Topics examined include the rationale for a reference measurement system for HDX-MS, attaining high accuracy

Precision and Robustness of 2D-NMR for Structure and Assessment of Filgrastim Biosimilars

February 5, 2016
Author(s)
Houman Ghasriani, Derek Hodgson, Robert G. Brinson, Ian McEwen, Lucinda F. Buhse, Steven Kozlowski, John Marino, Yves Aubin, David Keire
The higher order structure of biotherapeutics is a critical quality attribute (CQA) that can be evaluated by nuclear magnetic resonance (NMR) spectroscopy at atomic resolution. NMR spectral "fingerprinting" can directly establish drug substance structural

Survey Statistics of Automated Segmentations Applied to Optical Imaging of Mammalian Cells

January 8, 2016
Author(s)
Peter Bajcsy, Antonio Cardone, Joe Chalfoun, Michael W. Halter, Derek Juba, Marcin Kociolek, Michael P. Majurski, Adele P. Peskin, Carl G. Simon Jr., Mylene H. Simon, Antoine Vandecreme, Anne L. Plant, Mary C. Brady
The goal of this survey paper is to overview cellular measurements using optical microscopy imaging followed by automated image segmentation. The cellular measurements of primary interest are taken from mammalian cells and their components. They are

QUANTITY: An Isobaric Tag for Quantitative Glycomics

November 30, 2015
Author(s)
Shuang Yang, Meiyao Wang, Lijun Chen, Illarion Turko, Karen W. Phinney, Shuwei Li
We describe the design and synthesis of a novel set of iso-baric tags for quantitative glycan profiling, which will have broad applications in carbohydrate based biomarker dis-covery, therapeutic protein characterization, and vaccine development.

Current and Emerging Technologies to Characterize the Higher-Order Structure of Monoclonal Antibodies

October 15, 2015
Author(s)
John Marino, Robert G. Brinson, Jane E. Ladner, David Travis Gallagher, Luke Arbogast, Richard Huang, Jeffrey W. Hudgens, Elyssia S. Gallagher
In contrast to small molecule therapeutics whose conformations can be absolutely defined by constitution and stereochemistry, biopharmaceuticals are distinguished by the requirement for folding into higher order structures (secondary, tertiary, and

Determination of the Primary Sequence/ Structure

October 15, 2015
Author(s)
Catherine A. Mouchahoir, Mellisa Ly, Michaella Levy, Lisa E. Kilpatrick, Scott C. Lute, Karen W. Phinney, Lisa Marzilli, Kurt A. Brorson, Michael T. Boyne, Darryl Davis, John E. Schiel
The primary sequence of a protein, including therapeutic monoclonal antibodies (mAbs), is a critical quality attribute that determines a great deal of its functionality and stability. Significant effort is devoted to determining the complete amino acid

Glycan Analysis of NIST mAb Reference Material

October 15, 2015
Author(s)
John E. Schiel, Catherine A. Mouchahoir
N-linked glycosylation is a common post-translational modification that imparts structural heterogeneity to recombinant monoclonal antibody therapeutics. The various oligosaccharides attached to the CH2 domains of IgG can impact the efficacy, safety and

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

Structural Elucidation of Chemical and Post-translational Modifications of Monoclonal Antibodies

October 15, 2015
Author(s)
Wenzhou Li, James L. Kerwin, John E. Schiel, Catherine A. Mouchahoir, Darryl Davis, Andrew Mahan, Sabrina A. Benchaar
Therapeutic monoclonal antibodies (mAbs), a rapidly growing class of therapeutic drugs, present a daunting challenge for structural characterization. They are heterodimers of separate light and heavy chains comprising over 1200 amino acid residues. During

Rheology and Dynamics of Colloidal Superballs

June 9, 2015
Author(s)
John R. Royer, George L. Burton, Daniel L. Blair, Steven D Hudson
Recent advances in colloidal synthesis make it possible to generate a wide array of precisely controlled, non-spherical, shaped particles. However, relatively little is known about the role that particle shape plays in the dynamics of colloidal suspensions
Was this page helpful?