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Manufacturing

Biomanufacturing

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Displaying 1 - 25 of 378

Glucocorticoids Alter Bone Microvascular Barrier via MAPK/Connexin43 Mechanisms

January 20, 2025
Author(s)
Eun Jin Lee, Peter Lialios, Micaila Curtis, James Williams IV, Yoontae Kim, Paul Salipante, Steven Hudson, Mandy Esch, moshe levi, Joanna Kitlinska, Stella Alimperti
Glucocorticoids (GCs) are standard-of-care treatments for inflammatory and immune disorders, and their long-term use increases the risk of osteoporosis. Although GCs decrease bone functionality, their role in bone microvasculature is incompletely

Detecting Features of Antibody Structure Through Their Mediator-accessible Redox Activities

December 2, 2024
Author(s)
Dana Motabar, Eunkyoung Kim, Jinyang Li, Zhiling Zhao, Catherine Mouchahoir, David Travis Gallagher, John E. Schiel, Mamatha Garige, Carole Sourbier, Gregory F. Payne, William Bentley
Protein function relies on sequence, folding and post-translational modification and molecular measurements are commonly used to reveal these structural features. Here, we report an alternative approach that represents these molecular features as readily

Advancing Cell-Free Manufacturing: Challenges in Scale-up and Automation Workshop Report

November 20, 2024
Author(s)
Eugenia Romantseva, Fernanda Piorino Macruz de Oliveira, Chad Sundberg, G. Sitta Sittampalam, Elizabeth Strychalski
The workshop on Advancing Cell-free Manufacturing: Challenges in Scale-up and Automation sought to identify and prioritize actionable steps towards more reproducible, scalable, and automated cell-free systems for applications in bioengineering and

Simulated inter-filament fusion in embedded 3D printing

November 15, 2024
Author(s)
Leanne Friedrich, Ross Gunther
In embedded 3D printing (EMB3D), a nozzle extrudes continuous filaments inside of a viscoelastic support bath. Compared to other extrusion processes, EMB3D enables softer structures and print paths that conform better to the shape of the part. However

Variation of Site-Specific Glycosylation Profiles of Recombinant Influenza Glycoproteins

August 9, 2024
Author(s)
Zachary Goecker, Meghan Burke Harris, Concepcion Remoroza, Yi Liu, Yuri Mirokhin, Sergey Sheetlin, Dmitrii V. Tchekhovskoi, Xiaoyu (Sara) Yang, Stephen E. Stein
This work presents a detailed determination of site-specific N-glycan distributions of the recombinant influenza glycoproteins hemagglutinin (HA) and neuraminidase. Variation in glycosylation among recombinant glycoproteins is not predictable and can

Additive Manufacturing of Highly Entangled Polymer Networks

August 1, 2024
Author(s)
Abhishek Dhand, Matthew Davidson, Hannah Zlotnick, Thomas Kolibaba, Jason Killgore, Jason Burdick
Incorporation of polymer chain entanglements within a single network can synergistically improve stiffness and toughness, yet attaining such dense entanglements through vat photopolymerization additive manufacturing (e.g., digital light processing, DLP)

Mechanism of Action, Potency and Efficacy: Considerations for Cell and Gene Therapies

April 1, 2024
Author(s)
Carl Simon Jr., Anne L. Plant, Catherine Zander, Erich Bozenhardt, Christina Celluzzi, David Dobnik, Melanie Grant, John Hughes, Uma Lakshmipathy, Kok-Seong Lim, Laura Montgomery, Hesham Nawar, Thiana Nebel, Linda Peltier, James Sherley, Rouzbeh Taghizadeh, Eddie Tan, Sandrine Vessillier
One of the most challenging aspects of cell and gene therapy products (CGTPs) is defining mechanism of action (MOA), potency and efficacy of the product. This perspective examines these concepts and presents helpful ways to think about them through the

Comparison of N-glycopeptide to released N-glycan abundances and the influence of glycopeptide mass and charge state on N-linked glycosylation of IgG antibodies

March 7, 2024
Author(s)
Concepcion Remoroza, Meghan Burke Harris, Tytus Mak, Sergey Sheetlin, Yuri Mirokhin, Zachary Goecker, Brian T. Cooper, Mark Lowenthal, Xiaoyu (Sara) Yang, Guanghui Wang, Dmitrii V. Tchekhovskoi, Stephen E. Stein
We report the comparison of mass-spectral-based abundances of tryptic glycopeptides to fluorescence abundances of released labeled glycans and the effects of mass and charge state and in-source fragmentation on glycopeptide abundances. The primary

Quantification of mRNA in Lipid Nanoparticles Using Mass Spectrometry

December 26, 2023
Author(s)
Mark Lowenthal, Abigail Antonishek, Karen W. Phinney
Lipid nanoparticle-encapsulated messenger RNA (LNP-mRNA) holds great promise as a novel modality for treating a broad range of diseases. The ability to quantify mRNA accurately in therapeutic products helps to ensure consistency and safety. Here we

Single-Detector Double-Beam Modulation for High-Sensitivity Infrared Spectroscopy

October 25, 2023
Author(s)
Seongmin Kim, Yow-Ren Chang, Young Jong Lee
Balanced detection based on double beams is widely used to reduce common-mode noises, such as laser intensity fluctuation and irregular wavelength scanning, in absorption spectroscopy. However, employing an additional detector can increase the total system

Current challenges and recent advances on the path towards continuous biomanufacturing

June 21, 2023
Author(s)
Boonserm Kulvatunyou, Milos Drobnjakovic, Nenad Ivezic, Vijay Srinivasan, Roger Hart
Continuous biopharmaceutical manufacturing is currently a field of intense research due to its potential to make the entire production process more optimal for the modern, ever-evolving biopharmaceutical market. Compared to traditional batch manufacturing

Mechanical Regulation of Oral Epithelial Barrier Function

April 25, 2023
Author(s)
Eun Jin Lee, Paul Salipante, Anthony Kotula, Dana Graves, Stella Alimperti, Yoontae Kim
Epithelial cell function is modulated by mechanical forces imparted by the extracellular environment. The transmission of forces onto the cytoskeleton by modalities such as mechanical stress and matrix stiffness is necessary to address by the development

Monitoring Protein Complexation with Polyphosphazene Polyelectrolyte Using Automated Dynamic Light Scattering Titration and Asymmetric Flow Field Flow Fractionation and Protein Recognition Immunoassay

April 21, 2023
Author(s)
Michael Lueckheide, Alexander Marin, Harichandra Tagad, Nicholas Posey, Vivek Prabhu, Alexander Andrianov
Polyphosphazenes represent a class of intrinsically flexible polyelectrolytes with potent immunoadjuvant activity, which is enabled through non-covalent self-assembly with antigenic proteins by charge complexation. The formation of supramolecular complexes

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
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