U.S. flag

An official website of the United States government

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS
A lock ( ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

Manufacturing

Biomanufacturing

Search Publications

Search Title, Abstract, Conference, Citation, Keyword or Author
Published Date
Displaying 51 - 75 of 213

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

Fabrication of 3D Printed Hydroxyapatite Composite Scaffolds for Bone Regeneration

May 19, 2021
Author(s)
Yoontae Kim, Eun-Jin Lee, Albert Davydov, Stanislav Frakhtbeyen, Jonathan Seppala, Laurence Chow, Tagaki Shozo, Stella Alimperti
Additive biomanufacturing has been adapted in a wide variety of biomedical and tissue engineering applications, including orthopedics. The ability to print biocompatible, patient-specific geometries with controlled porosity, mechanical strength has made

New Peak Detection Performance Metrics from the MAM Consortium Interlaboratory Study

March 12, 2021
Author(s)
Catherine A. 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, Helena Maria Barysz, Michael Jahn, Ben Niu, Jihong Wang, 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, Hamakshi 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) 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 emerging ultra-high

Report of the 2019 NIST-FDA Workshop on Standards for Next Generation Sequencing Detection of Viral Adventitious Agents in Biologics and Biomanufacturing

February 22, 2021
Author(s)
Megan Cleveland, Bharathi Anekella, Mike Brewer, Pei-Ju Chin, Heather Couch, Eric Delwart, Jim Huggett, Scott Jackson, Javier Martin, Serge Monpoeho, Tom Morrison, Siemon Ng, David Ussery, Arifa Khan
Adventitious virus testing assures product safety by demonstrating the absence of viruses that may have been unintentionally introduced during the manufacturing process. The capabilities of next-generation or high-throughput sequencing (NGS/HTS) for broad

Grand Challenges in Pharmaceutical Research Series: Ridding the Cold Chain for Biologics

February 8, 2021
Author(s)
Yihua B. Yu, Katharine T. Briggs, Marc B. Taraban, Robert Brinson, John Marino
Biologics are complex pharmaceuticals that include formulated proteins, plasma products, vaccines, cell and gene therapy products, and biological tissues. These products are fragile and typically require cold chain for their delivery and storage

Recent Industrial Roadmaps to Enable Smart Manufacturing of Biopharmaceuticals

January 29, 2021
Author(s)
Sheng Lin-Gibson, Vijay Srinivasan
Biopharmaceutical manufacturing is an evolving industry with great potential to improve public health, but laden with technical and operational challenges. It has many features that are similar to other smart manufacturing industries, but it also has some

Conformational gating, dynamics and allostery in human monoacylglycerol lipase

October 28, 2020
Author(s)
Sergiy Tyukhtenko, Girija Rajarshi, Ioannis Karageorgos, Nikolai Zvonok, Kiran Vemuri, Jeffrey W. Hudgens, Xiaoyu Ma, Mahmoud L. Nasr, Alexandros Makriyannis, Kyle Anderson, Jason J. Guo, Gerhard Wagner
Inhibition of human Monoacylglycerol Lipase (hMGL) offers a novel approach for treating neurological diseases. The design of inhibitors, targeting active-inactive conformational transitions of the enzyme, can be aided by understanding the interplay between

Tissue Engineering Measurands

August 26, 2020
Author(s)
Greta Babakhanova, Carl Simon, Deepika Arora
A measurand is defined as the quantity that one intends to measure. As tissue engineering research translates into medical products, companies must prepare regulatory filings that contain many different types of measurement data that are collected about

Principal Component Analysis for Automated Classification of 2D Spectra and Interferograms of Protein Therapeutics: Influence of Noise, Reconstruction Details, and Data Preparation

July 22, 2020
Author(s)
Robert Brinson, Wade Elliott, Luke Arbogast, David Sheen, John Giddens, John Marino, Frank Delaglio
Protein therapeutics must retain their proper three-dimensional fold without forming aggregates for safe and effective use in the clinic. Therefore, the ability to monitor protein higher order structure (HOS) can be valuable throughout the lifecycle of a
Was this page helpful?