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Manufacturing

Biomanufacturing

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Displaying 1 - 25 of 206

Parameterizing modified nucleic acids for molecular simulations in the AMBER MD software environment

January 6, 2026
Author(s)
Olivia Love, Rodrigo Galindo-Murillo, Daniel Roe, Pablo D. Dans, Thomas E. Cheatham III, Akanksha Manghrani, Christina Bergonzo
Parameterizing modified nucleic acids is a difficult but necessary task for expanding the simulated space of oligonucleotides, including both naturally occurring structures and those with pharmaceutical relevance. In lieu of expensive and difficult

The structure and morphology of single-component oligomeric RNA delivery vectors derived from amphiphilic Charge-Altering Releasable Transporters

November 6, 2025
Author(s)
Paul Hurst, Yuan Jia, Summer Ramsay-Burrough, Rebecca McClellan, Joshua Arens, Samuel Khasnavis, Trevor del Castillo, Mahmoud AbdElwakil, Michael Lueckheide, Vivek Prabhu, Robert Waymouth
Recent advances in nucleic acid delivery have been inspired by efforts to mimic the function of natural viruses through the development of self-assemblies capable of transporting oligonucleotides across the cell and endosomal membranes. Lipid nanoparticles

NIST 2024 Rapid Microbial Testing Methods Workshop Report

September 25, 2025
Author(s)
Jason Kralj, Nancy Lin, Kirsten Parratt, Stephanie Servetas, Dawn Henke, Scott Jackson
The NIST-led Rapid Microbial Testing Methods (RMTM) Consortium launched in 2020 to develop standards and measurement-based solutions to advance the use of RMTMs in advanced therapy products. NIST hosted 4th annual workshop on RMTMs to update the community

Measurement quality metrics to improve absolute microbial cell counting

August 18, 2025
Author(s)
Kirsten Parratt, David Newton, Joy Dunkers, Jennifer Dootz, Monique Hunter, Alshae Logan, Laura Pierce, Sumona Sarkar, Stephanie Servetas, Nancy Lin
Total and viable microbial cell counts are increasingly important for applications including live biotherapeutic products, food safety, and probiotics. In microbiology, cells are quantified using methods such as colony forming unit (CFU), flow cytometry

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 therapies

May 2, 2024
Author(s)
Carl Simon, Anne 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
Abstract One of the most challenging aspects of developing advanced cell therapy products (CTPs) is defining the mechanism of action (MOA), potency and efficacy of the product. This perspective examines these concepts and presents helpful ways to think

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 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
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