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Displaying 26 - 50 of 378

Solid-state NMR characterization of lyophilized formulations of monoclonal antibody therapeutics.

January 26, 2023

Author(s)

Jacqueline Perodeau, Luke Arbogast, Andrew Nieuwkoop

Monoclonal antibodies (mAbs) are an important and growing class of biotherapeutic drug. Methods development for characterization of critical quality attributes, including higher order structure (HOS), of mAbs remains an area of active inquiry. Recently

Correlated Analytical and Functional Evaluation of Higher Order Structure Perturbations from Oxidation of NISTmAb

January 22, 2023

Author(s)

Tsega Solomon, Frank Delaglio, John Giddens, John Marino, Yihua Bruce Yu, Marc Taraban, Robert Brinson

The clinical efficacy and safety of protein-based drugs such as monoclonal antibodies (mAbs) rely on the integrity of the protein higher order structure (HOS) during product development, manufacturing, storage, and patient administration. As mAb-based

Effects of Salts and Surface Charge on the Biophysical Stability of a low pI Monoclonal Antibody

November 15, 2022

Author(s)

Kelvin B. Rembert, Young Jong Lee, Jifeng Zhang

The impact of five representative Hofmeister salts (NaCl, KCl, MgCl2, Na2SO4, and NaSCN) on the thermal stability and aggregation kinetics of a slightly acidic monoclonal antibody (mAb) were investigated under different pH conditions. The thermal stability

A history of adventitious agent contamination and current methods for the detection and prevention of pharmaceutical product contamination.

November 5, 2022

Author(s)

William Valiant, Kang Cai, Peter Vallone

Preventing adventitious agents from contaminating pharmaceutical products has been an important goal of regulatory agencies and industry for decades. Contamination of these products does not only erode consumer trust but also can have potentially serious

Fire Burn and Cauldron Bubble: What is in your Genome Editing Brew?

October 28, 2022

Author(s)

Simona Patange, Samantha Maragh

Genome editing is a rapidly evolving biotechnology with the potential to transform many sectors of industry such as agriculture, biomanufacturing, and medicine. This technology is enabled by an ever-growing portfolio of biomolecular reagents that span the

Sensor Technologies for Quality Control in Engineered Tissue Manufacturing

October 27, 2022

Author(s)

Mary Clare McCorry, Marcie Black, Chrysanthi Williams, Greta Babakhanova, Sumona Sarkar, Nathan Swami, Katherine A. Mirica, Sarah Boermeester, Abbie Underhill

The use of engineered cells, tissues, and organs has the opportunity to change the way injuries and diseases are treated. Commercialization of these groundbreaking technologies has been limited in part by the complex and costly nature of their manufacture

Applying the Cytocentric Principles to Regenerative Medicine for Reproducibility

October 18, 2022

Author(s)

Carl Simon Jr.

We establish here a set of cytocentric principles to improve use of cells for regenerative medicine (RM) applications. The five cytocentric principles are cells need 1) full-time protection from contamination, 2) physiologic simulation, 3) proper

Structural Fingerprinting of Antisense Oligonucleotide Therapeutics by Solution NMR Spectroscopy

October 4, 2022

Author(s)

Owen Becette, John Marino, Robert Brinson

Purpose. Antisense oligonucleotide (ASO) therapeutics are an emerging class of biopharmaceuticals to treat and prevent diseases, particularly those involving "undruggable" protein targets. Impurities generated throughout the ASO drug manufacturing and

Biomanufacturing Readiness Levels (BRL) - A Shared Vocabulary for Biomanufacturing Technology Development and Commercialization

September 7, 2022

Author(s)

John E. Schiel, Kelley Rogers, Sandeep Kedia, Jeffery Baker, Ruben Carbonell, Kelvin Lee, Christopher Roberts, John Erickson, Gene Schaefer, Stephanie Pluschkell

The Manufacturing Readiness Levels (MRLs) developed by the Department of Defense (DoD), are well established tools for describing the maturity of new technologies resulting from government sponsored Research and Development (R&D) programs, from the concept

Simulated stress mitigation strategies in embedded 3D bioprinting

August 30, 2022

Author(s)

Leanne Friedrich, Ross Gunther, Jonathan Seppala

Extrusion-based 3D bioprinting is a powerful tool for fabricating complex cell-laden constructs. Embedded Ink Writing (EIW) is an extrusion-based printing technique wherein a nozzle embedded into a support bath writes continuous filaments. Because it

Interlaboratory Attribute Analytics Metrics from the MAM Consortium Round Robin Study

August 26, 2022

Author(s)

Trina Mouchahoir, John E. Schiel, Rich Rogers, N. Alan Heckert, Benjamin Place, Aaron Ammerman, Xiaoxiao Li, Tom Robinson, Brian Schmidt, Chris M. Chumsae, Xinbi Li, Anton V. Manuilov, Bo Yan, Gregory O. Staples, Da Ren, Alexander J. Veach, Dongdong Wang, Wael Yared, Zoran Sosic, Yan Wang, Li Zang, Anthony M. Leone, Peiran Liu, Richard Ludwig, Li Tao, Wei Wu, Ahmet Cansizoglu, Andrew Hanneman, Greg W. Adams, Irina Perdivara, Hunter Walker, Margo Wilson, Arnd Brandenburg, Nick DeGraan-Weber, Stefano Gotta, Joe Shambaugh, Melissa Alvarez, X. Christopher Yu, Li Cao, Chun Shao, Andrew Mahan, Hirsh Nanda, Kristen Nields, Nancy Nightlinger, Ben Niu, Jihong Wang, Wei Xu, Gabriella Leo, Nunzio Sepe, Yan-Hui Liu, Bhumit A. Patel, Douglas Richardson, Yi Wang, Daniela Tizabi, Oleg V. Borisov, Yali Lu, Ernest L. Maynard, Albrecht Gruhler, Kim F. Haselmann, Thomas N. Krogh, Carsten P. Sonksen, Simon Letarte, Sean Shen, Kristin Boggio, Keith Johnson, Wenqin Ni, Himakshi Patel, David Ripley, Jason C. Rouse, Ying Zhang, Carly Daniels, Andrew Dawdy, Olga Friese, Thomas W. Powers, Justin B. Sperry, Josh Woods, Eric Carlson, K. Ilker Sen, St John Skilton, Michelle Busch, Anders Lund, Martha Stapels, Xu Guo, Sibylle Heidelberger, Harini Kaluarachchi, Sean McCarthy, John Kim, Jing Zhen, Ying Zhou, Sarah Rogstad, Xiaoshi Wang, Jing Fang, Weibin Chen, Ying Qing Yu, John G. Hoogerheide, Rebecca Scott, Hua Yuan

The multi-attribute method (MAM) was conceived as a single assay to potentially replace multiple single-attribute assays that have long been used in process development and quality control (QC) for protein therapeutics. MAM is rooted in traditional peptide

Rapid identification of short oligonucleotide impurities using lithium adduct consolidated MALDI-TOF mass spectrometry

August 8, 2022

Author(s)

Owen Becette, Anh Tran, Jace Jones, John Marino, Robert Brinson

Nucleic acids are an increasingly popular platform for the development of pharmaceuticals to treat and prevent multiple diseases including those where traditional small molecule and protein-based drug development efforts have failed. Short oligonucleotide

Structural Fingerprinting of siRNA Therapeutics by Solution NMR Spectroscopy

August 4, 2022

Author(s)

Owen Becette, Anh Tran, Jace Jones, John Marino, Robert Brinson

Nucleic acids are an increasingly popular platform for the development of biotherapeutics to treat a wide variety of illnesses, including diseases where traditional drug development efforts have failed. To date, there are 14 short oligonucleotide