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Manufacturing

Biomanufacturing

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Displaying 26 - 50 of 198

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

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

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

High-performance dual-gate graphene pH sensors

June 28, 2022
Author(s)
Son Le, Seulki Cho, Alexander Zaslavsky, Curt A. Richter, Arvind Balijepalli
High precision biophysical measurements that are portable and performed without prior labeling of the molecules can greatly benefit several areas of biotechnology and biophysics, but existing techniques often lack sufficient resolution. Field-effect

Engineering 3D Printed Scaffolds with Tunable Hydroxyapatite

June 15, 2022
Author(s)
Yoontae Kim, Eun Jin Lee, Anthony Kotula, Shozo Takagi, Laurence C. Chow, Styliani Alimperti
Bone grafting is a surgical procedure to bone repair due to trauma or diseases in the craniofacial and dental area. Current limitations of autogenous and allogeneic grafts are often associated with reduced host-graft integration due to geometrical confor

Interlaboratory Studies using the NISTmAb to Advance Biopharmaceutical Structural Analytics

May 5, 2022
Author(s)
Katharina Yandrofski, Trina Mouchahoir, M. Lorna De Leoz, David L. Duewer, Jeffrey W. Hudgens, Kyle Anderson, Luke Arbogast, Frank Delaglio, Robert Brinson, John Marino, Karen W. Phinney, Michael J. Tarlov, John E. Schiel
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 features and

Certification of Standard Reference Material(R) 3655 Glycans in Solution (Frozen)

April 12, 2022
Author(s)
Mark Lowenthal, Blaza Toman, Brian Lang, Karen W. Phinney
Standard Reference Material (SRM) 3655 is intended primarily for use as a calibration standard for the measurement of enzymatically released N-linked glycans. Applications of SRM 3655 include the benchmarking and comparability of analytical techniques, as

Testing Precision Limits of Neural Network-Based Quality Control Metrics in High-Throughput Digital Microscopy

January 26, 2022
Author(s)
Chris Calderon, Dean C. Ripple, Charudharshini Srinivasan, Youlong Ma, Michael J. Carrier, Theodore Randolph, Thomas O'Connor
Digital microscopy is used to monitor particulates such as protein aggregates within biologic pharmaceutical products. The digital images that result encode a wealth of information, but much of this image data is underutilized in pharmaceutical process

Quantitative Determination of Cell Viability Using Absorbance Microscopy

January 19, 2022
Author(s)
Greta Babakhanova, Stephen Zimmerman, Laura Pierce, Sumona Sarkar, Nicholas Schaub, Carl Simon Jr.
Cell viability is an essential measurement for cell therapy products. One of the most common tests is Trypan blue (TB) dye exclusion where blue-stained cells are counted via imaging. Typically, live and dead cells are counted based on pixel intensities of

AbsorbanceQ: An App for Generating Absorbance Images from Brightfield Images

January 4, 2022
Author(s)
Stephen Zimmerman, Carl Simon Jr., Greta Babakhanova
The AbsorbanceQ app converts brightfield microscope images into absorbance images that can be analyzed and compared across different operators, microscopes and time. Absorbance-based measurements are comparable, which is useful when the aim is to

Excipient Innovation Through Precompetitive Research

December 20, 2021
Author(s)
Bruce Yu, Marc Taraban, Katharine Briggs, Robert Brinson, John Marino
The mRNA COVID-19 vaccines developed by Pfizer/BioNTech and Moderna represent a triumph of vaccine development. The core mRNA component of these vaccines is now almost a household name. Unbeknownst to most people, however, is that each of the two mRNA

Improving end-user trust in the quality of commercial probiotic products

September 24, 2021
Author(s)
Scott Jackson, Jean Schoeni, Buffy Stahl
In a rapidly growing global probiotic market, end-users have difficulty distinguishing between high quality and poor quality products. This threatens consumer and healthcare provider trust in probiotic products. To address this problem, we recommend that

Site-Specific Glycan-Conjugated NISTmAb Antibody Drug Conjugate Standards

July 6, 2021
Author(s)
Brian Agnew, Shanhua Lin, Robert Aggeler, John E. Schiel, Catherine Mouchahoir
Antibody drug conjugates (ADCs) represent a rapidly growing modality for the treatment of numerous oncology indications. The complexity of analytical characterization method development is increased due to the potential for synthetic intermediates and

Comprehensive Analysis of Tryptic Peptides Arising from Disulfide Linkages in NISTmAb and Their Use for Developing a Mass Spectral Library

June 22, 2021
Author(s)
Qian Dong, Xinjian Yan, Yuxue Liang, Sanford Markey, Sergey L. Sheetlin, Concepcion Remoroza, William E. Wallace, Stephen Stein
This work presents methods for identifying and then creating a mass spectral library for disulfide-linked peptides originating from the NISTmAb. Analysis involved both partially- reduced and non-reduced proteins under neutral and weakly basic conditions
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