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Manufacturing

Biomanufacturing

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Displaying 151 - 175 of 198

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

Bioreactor Process Parameter Screening Utilizing a Plackett-Burman Design for a Model Monoclonal Antibody

March 11, 2015
Author(s)
John E. Schiel, Cyrus D. Agarabi, Scott C. Lute, Brittany K. Chavez, Michael T. Boyne, Kurt A. Brorson, Mansoor A. Kahn, Erik K. Read
Consistent high quality antibody yield is a key goal for cell culture bioprocessing. This endpoint is typically achieved in commercial settings through product and process engineering of bioreactor parameters during development. When the process is complex

2D 1HN, 15N Correlated NMR Methods at Natural Abundance for Obtaining Structural Maps and Statistical Comparability of Monoclonal Antibodies

March 1, 2015
Author(s)
Luke Arbogast, Robert G. Brinson, Catherine A. Mouchahoir, James T. Hoopes, John Marino
Purpose High-resolution nuclear magnetic resonance spectroscopy (NMR) provides a robust approach for producing unique spectral signatures of protein higher order structure at atomic resolution. Such signatures can be used as a tool to establish consistency

Mapping Monoclonal Antibody Structure by 2D 13C NMR at Natural Abundance

March 1, 2015
Author(s)
Luke Arbogast, Robert G. Brinson, John Marino
Monoclonal antibodies (mAbs) represent an important and rapidly growing class of biotherapeutics. Correct folding of a mAb is critical for drug efficacy, while misfolding can impact safety by eliciting unwanted immune or other off-target responses. Robust

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

Characterization of AlgMsp, an Alginate Lyase from Microbulbifer sp. 6532A

November 19, 2014
Author(s)
Jeffrey W. Hudgens, Steven M. Swift, Ryan D. Heselpoth, Patrick M. Bales, Daniel C. Nelson
Alginate is a polysaccharide produced by certain seaweeds and bacteria that consists of mannuronic acid and guluronic acid residues. Seaweed alginate is used in food and industrial chemical processes, while the biosynthesis of bacterial alginate is

Pairwise Alignment of Chromatograms using a Fisher-Rao Metric

September 2, 2014
Author(s)
William E. Wallace, Anuj Srivastava, Kelly H. Telu, Yamil Simon
A new approach to aligning chromatograms is introduced and applied to examples of metabolite identification by liquid chromatography mass spectrometry (LC MS). A square root representation of the chromatogram’s derivative coupled with a Fisher Rao

Trends in QconCATs for targeted proteomics

May 1, 2014
Author(s)
Junjun J. Chen, Illarion Turko
Targeted proteomics has received much attention because of the highly-sensitive, quantitative detection of proteins and post-translational modifications (PTMs). Quantification by targeted proteomics relies on mass spectrometry and isotope-labeled internal

Certification of Total Arsenic in Blood and Urine Standard Reference Materials by Radiochemical Neutron Activation Analysis and Inductively Coupled Plasma Mass Spectrometry

March 1, 2014
Author(s)
Rick L. Paul, William C. Davis, Karen E. Murphy, Colleen E. Bryan Sallee, Lee L. Yu, William F. Guthrie, Dennis D. Leber, Thomas W. Vetter
A newly developed procedure for determination of arsenic by radiochemical neutron activation analysis was used to measure arsenic in SRM 955c Toxic Elements in Caprine Blood and SRM 2668 Toxic Elements in Frozen Human Urine for the purpose of providing

Metabolite Profiling of a NIST Standard Reference Material for Human Plasma (SRM 1950) GC/MS, LC/MS, NMR and Clinical Laboratory Analyses, Libraries and Web-based resources

October 22, 2013
Author(s)
Yamil Simon, Mark S. Lowenthal, Lisa E. Kilpatrick, Maureen L. Sampson, Kelly H. Telu, Paul A. Rudnick, William G. Mallard, Daniel W. Bearden, Tracey B. Schock, Dmitrii V. Tchekhovskoi, Niksa Blonder, Xinjian Yan, Yuxue Liang, Yufang Zheng, William E. Wallace, Pedatsur Neta, Karen W. Phinney, Alan T. Remaley, Stephen E. Stein
Recent progress in metabolomics and the development of increasingly sensitive analytical techniques have renewed interest in global profiling, i.e., semi-quantitative monitoring of all chemical constituents of biological fluids. In this work, we have

Effects of Desialylation on Human alpha1-Acid Glycoprotein-Ligand Interactions

September 16, 2013
Author(s)
Richard Y. Huang, Jeffrey W. Hudgens
Human α1-Acid Glycoprotein (AGP), an acute phase glycoprotein, exists predominantly in blood. With its ability to bind basic, lipophilic, and acidic drugs, AGP has served as a drug carrier. It has been shown that the carbohydrate composition of AGP changes

Segmented chirped-pulse Fourier transform submillimeter spectroscopy for broadband gas analysis

August 15, 2013
Author(s)
Justin L. Neill, Brent J. Harris, Amanda L. Steber, Kevin O. Douglass, David F. Plusquellic, Brooks H. Pate
Chirped-pulse Fourier transform spectroscopy has recently been extended to millimeter wave spectroscopy as a technique for the characterization of room-temperature gas samples. Here we present a variation of this technique that significantly reduces the

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
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