Explanipedia

Detecting Features of Protein Structure through their Mediator-Accessible Redox Activities Open

Dana Motabar, Eunkyoung Kim, Jinyang Li, Zhiling Zhao, Trina Mouchahoir , et al. · 2023

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 fe…

Managing integrated continuous bioprocesses in real time: Deviations in product quality Open

Gustavo Grampp, Allen D. Bosley, Maen Qadan, John E. Schiel, Andy Spasoff , et al. · 2023

The N‐mAb case study was produced by the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to support teaching and learning for both industry and regulators around adoption of advanced manufacturing process tec…

Characterizing Adeno-Associated Virus Capsids with both Denaturing and Intact Analysis Methods Open

Jack P. Ryan, Marius M. Kostelic, Chih‐Chieh Hsieh, Joshua B. Powers, Craig A. Aspinwall , et al. · 2023

Adeno-associated virus (AAV) capsids are among the leading gene delivery platforms used to treat a vast array of human diseases and conditions. AAVs exist in a variety of serotypes due to differences in viral protein (VP) sequences, with d…

Humanized monoclonal antibody IgG1k, NISTmAb RM 8671 summary of 5 year stability verification (5YSV) Open

Katharina Yandrofski, John E. Schiel, Trina Mouchahoir, Srivalli Telikepalli, Dean C. Ripple , et al. · 2023

NISTmAb RM 8671 is an IgG1k 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 perf…

Biomanufacturing readiness levels [BRL]—A shared vocabulary for biopharmaceutical technology development and commercialization Open

Sandeep B. Kedia, Jeffrey C. Baker, Ruben G. Carbonell, Kelvin H. Lee, Christopher J. Roberts , et al. · 2022

The Manufacturing Readiness Levels (MRLs) developed by the Department of Defense are well‐established tools for describing the maturity of new technologies resulting from government‐sponsored Research and Development programs, from the con…

Bioindustrial manufacturing readiness levels (BioMRLs) as a shared framework for measuring and communicating the maturity of bioproduct manufacturing processes Open

Michael J. Smanski, Aristos Aristidou, Ryan Carruth, John Erickson, Mark Gordon , et al. · 2022

Readiness level (RL) frameworks such as technology readiness levels and manufacturing readiness levels describe the status of a technology/manufacturing process on its journey from initial conception to commercial deployment. More importan…

Attribute Analytics Performance Metrics from the MAM Consortium Interlaboratory Study Open

Trina Mouchahoir, John E. Schiel, Rich Rogers, N. Alan Heckert, Benjamin J. Place , et al. · 2022

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 tr…

Interlaboratory Studies Using the NISTmAb to Advance Biopharmaceutical Structural Analytics Open

Katharina Yandrofski, Trina Mouchahoir, M. Lorna De Leoz, David L. Duewer, Jeffrey W. Hudgens , et al. · 2022

Biopharmaceuticals such as monoclonal antibodies are required to be rigorously characterized using a wide range of analytical methods. Various material properties must be characterized and well controlled to assure that clinically relevant…

A Sensitive and Controlled Data-Independent Acquisition Method for Proteomic Analysis of Cell Therapies Open

Camille Lombard‐Banek, Kerstin I. Pohl, Edward Kwee, John T. Elliott, John E. Schiel · 2022

Mass spectrometry (MS)-based proteomic measurements are uniquely poised to impact the development of cell and gene therapies. With the adoption of rigorous instrumental performance qualifications (PQs), large-scale proteomics can move from…

Ligand-Bound Forced Degradation as a Strategy to Generate Functionally Relevant Analytical Challenge Materials for Assessment of CQAs Open

John P. Giddens, John E. Schiel · 2022

Therapeutic monoclonal antibodies (mAbs) contain a variety of amino acids that are susceptible to enzymatic, chemical, and physical modifications. These modifications can happen throughout production, purification, formulation, and storage…

Metrological tools for the reference materials and reference instruments of the NIST Material Measurement Laboratory Open

Carlos Beauchamp, Johanna E Camara, Jennifer Carney, Steven J. Choquette, Kenneth D. Cole , et al. · 2021

The National Institute of Standards and Technology (NIST), formerly the National Bureau of Standards, was established by the U.S. Congress in 1901 and charged with establishing a measurement foundation to facilitate U.S. and international …

New Peak Detection Performance Metrics from the MAM Consortium Interlaboratory Study Open

Trina Mouchahoir, John E. Schiel, Rich Rogers, N. Alan Heckert, Benjamin J. Place , et al. · 2021

The Multi-Attribute Method (MAM) Consortium was initially formed as a venue to harmonize best practices, share experiences, and generate innovative methodologies to facilitate widespread integration of the MAM platform, which is an emergin…

Mass Spectrometry Advances and Perspectives for the Characterization of Emerging Adoptive Cell Therapies Open

Camille Lombard‐Banek, John E. Schiel · 2020

Adoptive cell therapy is an emerging anti-cancer modality, whereby the patient’s 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 rec…

Cyberbiosecurity for Biopharmaceutical Products Open

Jennifer L. Mantle, Jayan Rammohan, Eugenia F. Romantseva, Joel Welch, Leah R. Kauffman , et al. · 2019

Cyberbiosecurity is an emerging discipline that addresses the unique vulnerabilities and threats that occur at the intersection of cyberspace and biotechnology. Advances in technology and manufacturing are increasing the relevance of cyber…

Antigenicity and Immunogenicity of Differentially Glycosylated Hepatitis C Virus E2 Envelope Proteins Expressed in Mammalian and Insect Cells Open

Richard A. Urbanowicz, Ruixue Wang, John E. Schiel, Zhen–Yong Keck, Melissa C. Kerzic , et al. · 2019

The development of a vaccine for hepatitis C virus (HCV) remains a global health challenge. A major challenge for vaccine development is focusing the immune response on conserved regions of the HCV envelope protein, E2, capable of elicitin…

Heterologous recombinant expression of non-originator NISTmAb Open

Lila Kashi, Katharina Yandrofski, Renae J. Preston, Luke W. Arbogast, John P. Giddens , et al. · 2018

The successful development and regulatory approval of originator and biosimilar therapeutic proteins requires a systems approach to upstream and downstream processing as well as product characterization and quality control. Innovation in p…

The NISTmAb Reference Material 8671 lifecycle management and quality plan Open

John E. Schiel, Abigail Turner · 2018

Development of orthogonal NISTmAb size heterogeneity control methods Open

Abigail Turner, Katharina Yandrofski, Srivalli Telikepalli, Jason King, N. Alan Heckert , et al. · 2018

Qualification of NISTmAb charge heterogeneity control assays Open

Abigail Turner, John E. Schiel · 2018

The NISTmAb Reference Material 8671 value assignment, homogeneity, and stability Open

John E. Schiel, Abby Turner, Trina Mouchahoir, Katharina Yandrofski, Srivalli Telikepalli , et al. · 2018

The NISTmAb Reference Material (RM) 8671 is intended to be an industry standard monoclonal antibody for pre-competitive harmonization of best practices and designing next generation characterization technologies for identity, quality, and …

Development of an LC-MS/MS peptide mapping protocol for the NISTmAb Open

Trina Mouchahoir, John E. Schiel · 2018

NIST Spectroscopic Measurement Standards. Open

Kenneth D. Cole, Paul C. DeRose, Hua‐Jun He, Erica V. Stein, Brian E. Lang , et al. · 2018

Ultraviolet (UV) absorbance measurements provide a rapid and reliable method to determine protein concentrations. the National Institute of standards and technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pa…

Multivariate Analysis of Two-Dimensional <sup>1</sup>H, <sup>13</sup>C Methyl NMR Spectra of Monoclonal Antibody Therapeutics To Facilitate Assessment of Higher Order Structure Open

Luke W. Arbogast, Frank Delaglio, John E. Schiel, John P. Marino · 2017

Two-dimensional (2D) ¹H-¹³C methyl NMR provides a powerful tool to probe the higher order structure (HOS) of monoclonal antibodies (mAbs), since spectra can readily be acquired on intact mAbs at natural isotopic abund…

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