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John E. Schiel, Coffman Jon, Bruno Marques, Griesbach Jan, Ambrose Williams, Gisela Ferreira, Rushd Khalaf, David Roush, Charles Haynes
Biopharmaceutical product and process development does not yet take advantage of predictive computational modeling to nearly the degree seen in industries based on smaller molecules. To assess and advance progress in this area, spirited coopetition was
Adoptive cell therapy is an emerging anti-cancer modality, whereby the patients own immune cells are engineered to express T-cell receptor (TCR) or chimeric antigen receptor (CAR). CAR-T cell therapies have advanced the furthest, with recent approvals of
Tytus D. Mak, Maryam Goudarzi, Evagelia C. Laiakis, Stephen E. Stein
In the past decade, the field of LC-MS based metabolomics has transformed from an obscure specialty into a major -omics platform for studying metabolic processes and biomolecular characterization. However, as a whole the field is still very fractured, as
Carl Simon, Nicholas J. Schaub, Petru S. Manescu, Sarala Padi, Mylene Simon, Peter Bajcsy, Nathan A. Hotaling, Joe Chalfoun, Mohamed Ouladi, Qin Wan, Kapil Bharti, Ruchi Sharma
Progressive increases in the number of cell therapies in the preclinical and clinical phases has prompted the need for reliable and non-invasive assays to validate transplant function in clinical biomanufacturing. Here, we developed a robust
Andrey Galkin, Yajing Chen, Sijy O'Dell, Roderico Acevedo, James Steinhardt, Yimeng Wang, Richard Wilson, Chi-I Chiang, Alexander Grishaev, John Mascola, Yuxing Li
Elicitation of broadly neutralizing Ab (bNAb) responses toward the conserved HIV-1 envelope (Env) CD4 binding site (CD4bs) by vaccination is an important goal for vaccine development and yet to be achieved. The outcome of previous immunogenicity studies
Xingjian Xu, Raquel Ruiz, Kaylin Adipietro, Christopher Peralta, Danya Ben-Hail, Kristen Varney, Mary Cook, Braden Roth, Paul Wilder, Thomas Cleveland, Alexander Grishaev, Heather Neu, Sarah Michel, Wenbo Yu, Dorothy Beckett, Richard Rustandi, Alex MacKerell, Amedee des Georges, Edwin Pozharski, David Weber
Targeting Clostridium difficile infection is challenging because treatment options are limited, and high recurrence rates are common. One reason for this is that hypervirulent C. difficile strains often have a binary toxin termed the C. difficile toxin, in
Cellular DNA damage is implicated in the etiology and progression of many different types of human disorders and diseases. Much of the current research in the DNA damage field is devoted towards understanding the mechanisms and biological implications of
Kaleb J. Duelge, Jeremie Parot, Vincent A. Hackley, Michael R. Zachariah
Protein aggregation is a significant concern in bioprocessing and end use applications. Here the thermal aggregation kinetics of bovine serum albumin (BSA) and α-chymotrypsinogen A (α- chymo) were measured over a range of concentrations and temperatures by
Nicholas Callahan, Jennifer A. Tullman, John Marino, Zvi Kelman
Proteomic analysis can be a critical bottleneck in cellular characterization. The current paradigm relies primarily on mass spectrometry of peptides and affinity reagents (i.e. antibodies), both of which require a priori knowledge of the sample. A non
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
Dan Bearden, David A. Sheen, Yamil Simon, Bruce A. Benner Jr., Werickson Fortunato de Carvalho Rocha, Niksa Blonder, Katrice A. Lippa, Richard Beger, Laura Schnackenberg, Jinchun Sun, Khyati Mehta, Amrita Cheema, Haiwei Gu, Ramesh Marupaka, Nagana Gowda, Daniel Raftery
There is a lack of experimental reference materials and standards for metabolomics measurements, such as urine, plasma, and other human fluid samples. Reasons include difficulties with supply, distribution, and dissemination of information about the
A pulsed element is proposed allowing the selective inversion of a single 1H nucleus, without regard to the presence of other degenerate 1H nuclei, provided that it is coupled to a heteronuclear spin with adequate chemical shift resolution in a 2D
David T. Gallagher, Robert G. Brinson, John P. Marino, nazzareno dimasi
Antibody-drug conjugates (ADCs) are a class of biotherapeutic drugs designed as targeted therapies for the treatment of cancer. Among the challenges in generating an effective ADC is the choice of an effective conjugation site on the IgG. One common method
Dynamic imaging analysis instruments are used for sizing particles of different types that might appear in a biopharmaceutical. These instruments are calibrated using polystyrene latex microspheres in water, which is a significantly different system than
Erik M. Leith, William Brad O'Dell, Na Ke, Colleen McClung, Mehmet Berkmen, Christina Bergonzo, Robert G. Brinson, Zvi Kelman
Monoclonal antibodies (mAbs) represent an important platform for the development of biotherapeutic products. While most mAbs are produced in mammalian cells, there are several examples of mAbs made in Escherichia coli, including therapeutic fragments. When
At the request of the National Institutes of Healths (NIHs) Office of Dietary Supplements (ODS) and in conjunction with the Centers for Disease Control and Prevention (CDC), in 2017 the National Institute of Standards and Technology (NIST) conducted the
Yang Yang, Parinaz Fathi, Glenn Holland, Dipanjan Pan, Nam Wang, Mandy Esch
We have developed a pumpless cell culture platform that can recirculate small amounts of cell culture medium (400 µL) in a unidirectional or bidirectional flow pattern. The device produces an average wall shear stress of up to 0.587 Pa ± 0.006 Pa without
Chi Zang, Debadrita Paria, Stephen Semancik, Ishan Barman
Biosensing based on localized surface plasmon resonance (LSPR) relies on concentrating light to a nanometeric spot and leads to a highly enhanced electromagnetic field near a metal nanostructure. Here, we present a design of plasmonic nanostructures based
Recently, fluorescence imaging using shortwave-wavelength infrared light (SWIR, 1,000-2,000 nm) has been proposed as having advantage over conventional near-infrared fluorescence (NIRF) imaging due to the reduced tissue scattering, negligible
Leona D. Scanlan, Pawel Jaruga, Sanem Hosbas Coskun, Christopher Sims, Shannon Hanna, Jamie L. Almeida, David N. Catoe, Bryant C. Nelson, Miral M. Dizdar, Erdem Coskun
Caenorhabditis elegans (C. elegans) is used as a medical and systems toxicity model organism for environmental and developmental assays that include high-throughput methods and genetic studies. However, little is known about background levels of
Yamil Simon, Ramesh Marupaka, Xinjian Yan, Yuxue Liang, Kelly H. Telu, Yuri Mirokhin, Stephen E. Stein
A large fraction of ions observed in electrospray liquid chromatography–mass spectrometry (LC–ESI-MS) experiments of biological samples remain unidentified. One of the main reasons for this is that spectral libraries of pure compounds fail to account for
The DNA sequencing technologies in use today produce either highly accurate short reads or less-accurate long reads. We report the optimization of circular consensus sequencing (CCS) to improve the accuracy of single-molecule real-time (SMRT) sequencing
Joshua Hunsberger, Martha Lundberg, Julie Allickson, Claudia Zylberberg, Sarah Beachy, Carl Simon
This perspective article is inspired by a workshop entitled "Cell and Tissue Manufacturing Innovation" that was held at the Tissue Engineering and Regenerative medicine Society (TERMIS). Five main concepts are discussed: 1) the US National Academies' Forum