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 213

THE GUT MICROBIOME AND XENOBIOTICS: IDENTIFYING KNOWLEDGE GAPS

July 1, 2020
Author(s)
Vicki L. Sutherland, Charlene A. McQueen, donna Mendrick, donna gulezian, Carl Cerniglia, Steven Foley, Samuel Forry, Sangeeta Khare, Xue Liang, Jose E. Manautou, Donald Tweedie, howard young, Alexander Aleksenkyo, frank burns, Rod Dietert, Katherine Karberg, alan wilson, connie chen
There is an increasing awareness that the gut microbiome plays a critical role in human health and disease, but mechanistic insights are often lacking. In June 2018, the Health and Environmental Sciences Institute (HESI) held a workshop, "The Gut

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

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

EcoFAB: Advancing microbiome science through standardized fabricated ecosystems

June 21, 2019
Author(s)
Karsten Zengler, Kirsten Hofmockel, Scott Behie, Hans Bernstein, James Brown, Jos? Dinneny, Sheri Floge, Samuel Forry, Matthias Hess, Scott Jackson, Stephen Lindemann, Jennifer Pett-Ridge, Elizabeth Shank, Ophelia Venturelli, Matthew Wallenstein, Nitin Baliga, Christer Jansson, Trent Northen
Microbiome science is arguably the fastest-advancing research field in biology today. However, current efforts are largely focused on disparate and often irreproducible experimental systems. Here we present the results of a one-and-a-half-day workshop that

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
Was this page helpful?