NOTICE: Due to a lapse in annual appropriations, most of this website is not being updated. Learn more.

Form submissions will still be accepted but will not receive responses at this time. Sections of this site for programs using non-appropriated funds (such as NVLAP) or those that are excepted from the shutdown (such as CHIPS and NVD) will continue to be updated.

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 76 - 100 of 198

Phase-Appropriate Application of Analytical Methods to Monitor Subvisible Particles Across the Biotherapeutic Drug Product Life Cycle

October 30, 2019
Author(s)
Roman Mathaes, Linda Narhi, Andrea Hawe, Anja Matter, Karoline Bechtold-Peters, Sophia Kenrick, Sambit Kar, Olga Laskina, John Carpenter, Richard E. Cavicchi, Ellen Koepf, Neil Lewis, Rukman De Sliva, Dean C. Ripple
The phase-appropriate application of analytical methods to characterize, monitor, and control particles is an important aspect of the development of safe and efficacious biotherapeutics. The AAPS Product Attribute and Biological Consequences (PABC) focus

Development of Protein-Like Reference Material for Semi-Quantitatively Monitoring Visible Proteinaceous Particles in Biotherapeutics

June 17, 2019
Author(s)
Srivalli Telikepalli, Kristen Gonzalez, Sonia Dragulin-Otto, Dean C. Ripple, Michael J. Carrier, M Khan
Visual inspection of biotherapeutics is required at various stages of drug production and manufacturing to ensure quality and consistency of drug products. Inherent particles, composed of aggregated protein from the drug-product, may potentially pose

Hydrogen-Deuterium Exchange Mass Spectrometry (HDX-MS) Centroid Data Measured between 3.6 degC and 25.4 degC for the Fab Fragment of NISTmAb

May 2, 2019
Author(s)
Jeffrey W. Hudgens, Elyssia S. Gallagher, Ioannis L. Karageorgos, Kyle W. Anderson, Richard Y. Huang, Guodong Chen, George M. Bou-Assaf, Alfonso Espada, Michael J. Chalmers, Edu Harguindey, Hui-Min Zhang, Benjamin T. Walters, Jennifer Zhang, John Venable, Caitlin Steckler, In Hee Park, Ansgar Brock, Xiaojun Lu, Ratnesh Pandey, Arun Chandramohan, Ganesh Srinivasan Anand, Sasidhar N. Nirudodhi, Justin Sperry, Jason C. Rouse, James A. Carroll, Kasper D. Rand, Ulrike Leurs, David D. Weis, Mohammed A. Al-Naqshabandi, Daniel Deredge, Patrick Wintrode, Malvina Papanastasiou, John D. Lambris, Sheng Li, Sarah Urata
The spreadsheet file reported herein provides centroid data, descriptive of deuterium uptake, for the Fab Fragment of NISTmAb (PDB: 5K8A) reference material, as measured by the bottom-up hydrogen-deuterium exchange mass spectrometry (HDX-MS) method. The

Interlaboratory Comparison of Hydrogen-Deuterium Exchange Mass Spectrometry (HDX-MS) MMeasurements of the Fab fragment of NISTmAb

May 2, 2019
Author(s)
Jeffrey W. Hudgens, Ioannis L. Karageorgos, Elyssia S. Gallagher, Kyle W. Anderson, James J. Filliben, Richard Y. Huang, Guodong Chen, Michael J. Chalmers, Benjamin T. Walters, Jennifer Zhang, John Venable, Caitlin Steckler, In Hee Park, Ansgar Brock, Xiaojun Lu, Ratnesh Pandey, Arun Chandramohan, Ganesh Srinivasan Anand, Sasidhar N. Nirudodhi, Justin Sperry, Jason C. Rouse, James A. Carroll, Kasper D. Rand, Ulrike Leurs, David D. Weis, Mohammed A. Al-Naqshabandi, Tyler S. Hageman, Patrick Wintrode, John D. Lambris, Sarah Urata, George M. Bou-Assaf, Alfonso Espada
Hydrogen-deuterium exchange mass spectrometry (HDX-MS) is an established, powerful tool for investigating protein-ligand interactions, protein folding, and protein dynamics. However, HDX-MS is still an emergent tool for quality control of

Reference Material 8634: Ethylene Tetrafluoroethylene for Particle Size Distribution and Morphology

May 1, 2019
Author(s)
Dean C. Ripple, Srivalli Telikepalli, Kristen L. Steffens, Michael J. Carrier, Christopher B. Montgomery, Nicholas W. Ritchie, John Lu
Reference Material (RM) 8634 is a NIST particle standard produced from abraded ethylene tetrafluoroethylene (ETFE), a chemically inert polymer, that will help standardize and allow more accurate monitoring of subvisible proteinaceous particles in

Bridging communities in the field of nanomedicine

April 30, 2019
Author(s)
Blanka Halamoda-Kenzaoui, Simon Baconnier, Thierry Bastogne, Didier Bazile, Patrick Boisseau, Gerrit Borchard, Sven E. Borgos, Luigi Calzolai, Karin Cederbrant, Gabriella di Felice, Tiziana Di Francesco, Marina Dobrovolskaia, Rog?rio Gaspar, Bel?n Gracia, Vincent A. Hackley, Lada Leyens, Neill Liptrott, Margriet Park, Anil Patri, Gert Roebben, Matthias Roesslein, Ren? Th?rmer, Patricia Urb?n L?pez, Val?rie Zuang, Susanne Bremer-Hoffmann
The workshop "Bridging communities in the field of nanomedicine" was hosted by the European Commission Joint Research Centre on 27-28 September 2017. It gathered experts from regulatory bodies, research institutions and industry to discuss the main

Enabling adoption of 2D-NMR for the higher order structure assessment of monoclonal antibody therapeutics

January 1, 2019
Author(s)
Robert G. Brinson, John P. Marino, Frank Delaglio, Luke W. Arbogast, Ryan M. Evans, Anthony J. Kearsley, Yves Aubin, Gregory Pierens, Xinying Jia, David Keizer, Jonas Stahle, Goran Widmalm, Chad Lawrence, Patrick Reardon, John Cort, Koichi Kato, Stuart Parnham, Andreas Blomgren, Torgny Rundlof, Kang Chen, David Keire, Thea Suter-Stahel, Gerhard Wider, Donna Baldisseri, Julie Wu, Mats Wikstrom, Medhi Mobli
Of the top ten drugs on the global market in 2016, seven of them are biologics with a combined market value of over US$60 billion. Moreover, around 2,800 biopharmaceuticals, many of them monoclonal antibodies (mAbs), are in some stage of clinical

3D Printing in Cell Culture Systems and Medical Applications

December 18, 2018
Author(s)
Max J. Lerman, Josephine Lembong, John G. Gillen, John P. Fisher
3D printing serves an important role in various biomedical research applications, including but not limited to culture systems and implantable devices. In this review, we discuss recent development in the applications of 3D printing technologies for

Combinatorial Cassettes for Higher-Throughput Screening of Osteogenesis

October 4, 2018
Author(s)
Carl G. Simon Jr., Subhadip Bodhak, Hariharan K. Iyer, Luis Fernandez de Castro Diaz, Pam Robey, Azusa Maeda, Sergei Kuznetsov
Animal models are the most biologically relevant method for measuring the osteogenic capability of bone graft formulations. However, animal experiments are slow, tedious and the results can be highly variable, even when conducted within the same lab. In

Platform development for expression and purification of stable isotope labeled monoclonal antibodies in Escherichia coli

October 1, 2018
Author(s)
Prasad T. Reddy, Robert G. Brinson, James T. Hoopes, Colleen McClung, Na Ke, Lila Kashi, Mehmet Berkmen
Proteins labeled with stable isotopes play an important role in structural and biophysical studies including nuclear magnetic resonance, small angle neutron scattering, neutron reflectometry, quantitative mass spec and more. The most common and cost

Platform development for expression and purification of stable isotope labeled monoclonal antibodies in Escherichia coli

October 1, 2018
Author(s)
Robert Brinson, James T. Hoopes, Colleen McClung, Na Ke, Lila Kashi, Mehmet Berkmen, Zvi Kelman, Prasad T. Reddy
Proteins labeled with stable isotopes play an important role in structural and biophysical studies including nuclear magnetic resonance, small angle neutron scattering, neutron reflectometry, quantitative mass spec and more. The most common and cost

NIST Spectroscopic Measurement Standards

May 1, 2018
Author(s)
Paul C. DeRose, Kenneth D. Cole, Aaron Urbas, Steven J. Choquette, Evelyn Solis, Erica V. Stein, John E. Schiel, Brian Lang, Hua-Jun He
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) 2082as a pathlength standard for UV

The role of mass spectrometry in the characterization of biologic protein products

April 25, 2018
Author(s)
Deepali Rathore, John E. Schiel, Anneliese Faustino, Eric Pang, Michael Boyne, Sarah M. Rogstad
Introduction: Mass spectrometry (MS) is widely used in the characterization of biomolecules including peptide and protein therapeutics. These biotechnology products have seen rapid growth over the past few decades and continue to dominate the global

Qualification of NISTmAb charge heterogeneity control assays

March 18, 2018
Author(s)
Abigail Turner, John E. Schiel
The NISTmAb is a monoclonal antibody Reference Material from the National Institute of Standards and Technology; it is a class-representative IgG1κ intended serve as a pre-competitive platform for harmonization and technology development in the
Was this page helpful?