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Manufacturing

Biomanufacturing

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Displaying 51 - 75 of 198

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

Improving patient outcomes with regenerative medicine: How to move the needle forward in cell manufacturing, standards, 3D bioprinting, AI enabled automation, education and training

June 17, 2020
Author(s)
Carl Simon, Josh Hunsberger, Claudia Zylberberg, Preveen Ramamoorthy, Thomas Tubon, Crystal Ruff, Ram Bedi, Kurt Gielen, Lynn Fisher, Jed Johnson, Priya Barankiak, Behzad Mahdavi, Michael Hadjisavas, Shannon Eaker, Cameron Miller
Regenerative Medicine Manufacturing Society (RMMS), is the first and only professional society dedicated specifically towards advancing manufacturing solutions for the field of regenerative medicine. RMMS' vision is to provide greater patient access to

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

Quantitative Bright-Field Microscopy Combined with Deep Neural Networks Predict Live Tissue Function

February 29, 2020
Author(s)
Carl Simon, Nicholas J. Schaub, Petru S. Manescu, Sarala Padi, Mylene Simon, Peter Bajcsy, Nathan A. Hotaling, Joe Chalfoun, Mohamed Ouladi, Qin Wan, Kapil Bharti, Ruchi Sharma
Progressive increases in the number of cell therapies in the preclinical and clinical phases has prompted the need for reliable and non-invasive assays to validate transplant function in clinical biomanufacturing. Here, we developed a robust

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

Strategies for Development of a Next-Generation Protein Sequencing Platform

January 1, 2020
Author(s)
Nicholas Callahan, Jennifer A. Tullman, John Marino, Zvi Kelman
Proteomic analysis can be a critical bottleneck in cellular characterization. The current paradigm relies primarily on mass spectrometry of peptides and affinity reagents (i.e. antibodies), both of which require a priori knowledge of the sample. A non

Establishing Standards and Methods for Qualification and Validation of New Particle Measurement Technologies

November 12, 2019
Author(s)
Srivalli Telikepalli, Dean C. Ripple, Kurt D. Benkstein, Kristen L. Steffens, Michael J. Carrier, Christopher B. Montgomery
Numerous particle sizing and counting methods exist for measuring particles in the submicrometer, subvisible, and visible size range. This article will briefly describe some key aspects that need to be considered for the most commonly used methods in order

Selective spin inversion in solution by magic field cross polarization

November 1, 2019
Author(s)
Joel Tolman, Luke Arbogast
A pulsed element is proposed allowing the selective inversion of a single 1H nucleus, without regard to the presence of other degenerate 1H nuclei, provided that it is coupled to a heteronuclear spin with adequate chemical shift resolution in a 2D
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