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Manufacturing

Biomanufacturing

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Displaying 101 - 125 of 210

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 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

The NISTmAb Tryptic Peptide Spectral Library for Monoclonal Antibody Characterization

March 6, 2018
Author(s)
Qian Dong, Yuxue Liang, Xinjian Yan, Sanford Markey, Yuri Mirokhin, Dmitrii V. Tchekhovskoi, Tallat H. Bukhari, Stephen E. Stein
We describe the creation of a mass spectral library composed of all identifiable spectra derived from the tryptic digest of a therapeutic monoclonal antibody. The NISTmAb library is a unique reference peptide spectral library developed from a total of six

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

March 1, 2018
Author(s)
Catherine A. Mouchahoir, John E. Schiel
Peptide mapping is a component of the analytical toolbox used within the biopharmaceutical industry to aid in the identity confirmation of a protein therapeutic and to monitor degradative events such as oxidation or deamidation. These methods offer the

Large Field of View Quantitative Phase Imaging of Induced Pluripotent Stem Cells and Optical Pathlength Reference Materials

February 23, 2018
Author(s)
Edward J. Kwee, Alexander W. Peterson, Jeffrey R. Stinson, Michael W. Halter, Liya Yu, Michael P. Majurski, Joe Chalfoun, Peter Bajcsy, John T. Elliott
Induced pluripotent stem cells (iPSCs) are reprogrammed cells that can have heterogeneous biological potential. Quality assurance metrics of reprogrammed iPSCs will be critical to ensure reliable use in cell therapies and personalized diagnostic tests. We

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

Effects of Distal Residues Mutations on the Structure, Dynamics and Catalysis of Human Monoacylglycerol Lipase

January 29, 2018
Author(s)
Sergiy Tyukhtenko, Girija Rajarshi, Ioannis Karageorgos, Nikolai Zvonok, Elyssia S. Gallagher, Hongwei Huang, Kiran Vemuri, Jeffrey W. Hudgens, Alexandros Makriyannis
An understanding of how conformational dynamics modulates function and catalysis of human monoacylglycerol lipase (hMGL), an important pharmaceutical target, can facilitate the development of novel modulatory ligands. Here, we report the discovery and

Tissue Inhibitor of Metalloprotease-2: bioprocess development, physicochemical, biochemical and biological characterization of highly expressed recombinant protein

December 1, 2017
Author(s)
Ananda Chowdhury, Robert G. Brinson, Beiyang Wei, William G. Stetler-Stevenson
Tissue Inhibitor of Metalloprotease -2 (TIMP-2) is a secreted, 21 kDa, multifunctional protein. It was first described as an endogenous inhibitor of matrix metalloproteases (MMPs) that prevents protease-mediated breakdown of the extracellular matrix often

The role of human monoacylglycerol lipase (hMAGL) binding pocket in breakup of unsaturated phospholipid membranes

November 1, 2017
Author(s)
Ioannis L. Karageorgos, Vitalii I. Silin, nikolai zvonok, John P. Marino, David Janero, Alexandros Makriyannis
Human monoacylglycerol lipase (hMAGL) plays a key role in homeostatic tuning of the endocannabinoid signaling system and supports aggressive tumorogenesis, making this enzyme a promising therapeutic target. hMAGL features a membrane-associated lid domain
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