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Health

Pharmaceuticals

Search Publications

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Displaying 26 - 50 of 122

228Th breakthrough in 224Ra samples: what can we know and when can we know it?

April 6, 2020
Author(s)
Denis E. Bergeron, Ryan P. Fitzgerald, Leticia S. Pibida
Recent renewed interest in radium-224 (224Ra) as a radiotherapeutic agent prompted the development of a primary standard for activity at the National Institute of Standards and Technology (NIST). The 224Ra decay chain includes the emission four alpha

Highland games: A benchmarking exercise in predicting biophysical and drug properties of monoclonal antibodies from amino acid sequences

April 6, 2020
Author(s)
John E. Schiel, Coffman Jon, Bruno Marques, Griesbach Jan, Ambrose Williams, Gisela Ferreira, Rushd Khalaf, David Roush, Charles Haynes
Biopharmaceutical product and process development does not yet take advantage of predictive computational modeling to nearly the degree seen in industries based on smaller molecules. To assess and advance progress in this area, spirited coopetition was

The impact of the metal interface on the stability and quality of a therapeutic fusion protein

January 9, 2020
Author(s)
Adrian P. Defante, Steven D. Hudson, Cavan K. Kalonia, Emma Keegan, Steven Bishop, Paul Santacroce, Satish Hasige
Subvisible particle formation which occurs after the sterile filtration step of the fill/finish process is challenge that may occur during the development of biotherapeutics with complex molecular structures. Here, we show that a stainless-steel pump head

Sizing up the Next Generation of Nanomedicines

December 11, 2019
Author(s)
Jeffrey D. Clogston, Vincent A. Hackley, Adriele Prina-Mello, Sanyogitta Puri, Silvia Sonzini, Patrick Lim Soo
During the past two decades the field of nanomedicines has experienced significant progress. To date, over sixty nanoparticle (NP) formulations have been approved in the US and EU while many others are in clinical or preclinical development, indicating a

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

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

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

Identification of a mechanogenetic link between substrate stiffness and chemotherapeutic response in breast cancer

February 25, 2019
Author(s)
Brian G. Bush, Scott H. Medina, Emily Sevcik, Maggie Cam, Frank W. DelRio, Kaustav Nandy, Joel P. Schneider
Mechanical feedback from the tumor microenvironment regulates an array of processes underlying cancer biology. For example, increased stiffness of mammary extracellular matrix (ECM) drives malignancy and alters the phenotypes of breast cancer cells

Certification of Standard Reference Material 2365 BK Virus DNA Quantitative Standard

August 29, 2018
Author(s)
Megan H. Cleveland, Natalia Farkas, Kevin M. Kiesler, Blaza Toman, Peter M. Vallone
Standard Reference Material (SRM) 2365 is intended for use in the value assignment of BK virus deoxyribonucleic acid (DNA) to BK DNA controls and standards. A unit of SRM 2365 consists of a well characterized, linearized plasmid, containing BK virus DNA

Nanoscale partitioning of Paclitaxel in Hybrid Lipid-Polymer Membranes

August 6, 2018
Author(s)
Mohit Tuteja, Minjee Kang, Cecilia Leal, Andrea Centrone
Paclitaxel is a powerful drug against restenosis and many forms of cancer. However, its clinical application hinges on the ability to achieve suitable stabilized drug concentrations in an aqueous suspension while hindering drug crystallization. To engineer

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

Protein Adsorption and Layer Formation at the Stainless Steel - Solution Interface Mediates Shear-Induced Particle Formation for an IgG1 Monoclonal Antibody

February 9, 2018
Author(s)
Cavan K. Kalonia, Frank Heinrich, Joseph E. Curtis, Sid Raman, Maria A. Miller, Steven Hudson
Passage of specific protein solutions through certain pumps, tubing, and/or filling nozzles can result in the production of unwanted subvisible protein particles (SVP). In this work, surface mediated SVP formation was investigated. Specifically, the

Phase noise generated by vibration of bacteria adhered to a quartz resonator

September 22, 2017
Author(s)
Ward L. Johnson, Danielle C. France, F L. Walls, William T. Cordell, Nikki S. Rentz
An approach is presented for sensing mechanical fluctuations of bacteria, with potential application in monitoring microbial responses to changes in chemical environment, such as antimicrobial intervention. Bacteria are tethered to a quartz crystal

Small molecule inhibitors of DNA glycosylases as potential drugs in cancer therapy

August 31, 2017
Author(s)
M Miral Dizdar, Aaron C. Jacobs, Nathan Donley, Marcus J. Calkins, Ajit Jadhav, Dorjbal Dorjsuren, David Maloney, Anton Simeonov, Pawel Jaruga, Erdem Coskun, Amanda K. McCullough, R. S. Lloyd
Statement of the Problem: Most chemotherapeutic agents kill cancer cells by damaging DNA. Cancer cells overexpress DNA repair proteins and thus increase DNA repair capacity that can cause resistance to therapy by removing DNA lesions before they become

Conformational Changes in Active and Inactive States of Human PP2C? characterized by Hydrogen/Deuterium Exchange-Mass Spectrometry

May 8, 2017
Author(s)
Sharlyn Mazur, Elyssia S. Gallagher, Subrata Debnath, Stewart R. Durell, Kyle Anderson, Lisa M. Jenkins, Ettore Appella, Jeffrey W. Hudgens
PPM serine/threonine protein phosphatases function in signaling pathways and require millimolar concentrations of Mn2+ or Mg2+ ions for activity. Whereas the crystal structure of human PP2Cα displayed two tightly bound Mn2+ ions in the active site, recent
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