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Search Publications by: Carl G. Simon, Jr., Ph.D. (Fed)

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Displaying 1 - 25 of 265

Nondestructive, Longitudinal, 3D Cell Viability Assessment in a Multi-well Plate System Using Electron Paramagnetic Resonance Oxygen Imaging

May 1, 2024
Author(s)
Safa Hameed, Navin Viswakarma, Eliyas Siddiqui, Greta Babakhanova, Carl Simon Jr., Boris Epel, Mrignayani Kotecha
Cell viability is an essential measurement for cell therapy, tissue engineered medical products (TEMPs), drug development, and many other biological processes and products. These systems rely on viable, healthy, and functional cells to work as intended

Mechanism of Action, Potency and Efficacy: Considerations for Cell and Gene Therapies

April 1, 2024
Author(s)
Carl Simon Jr., Anne L. Plant, Catherine Zander, Erich Bozenhardt, Christina Celluzzi, David Dobnik, Melanie Grant, John Hughes, Uma Lakshmipathy, Kok-Seong Lim, Laura Montgomery, Hesham Nawar, Thiana Nebel, Linda Peltier, James Sherley, Rouzbeh Taghizadeh, Eddie Tan, Sandrine Vessillier
One of the most challenging aspects of cell and gene therapy products (CGTPs) is defining mechanism of action (MOA), potency and efficacy of the product. This perspective examines these concepts and presents helpful ways to think about them through the

Three-dimensional, label-free cell viability measurements in tissue engineering scaffolds using optical coherence tomography

March 14, 2023
Author(s)
Greta Babakhanova, Anant Agrawal, Deepika Arora, Allison Horenberg, Jagat Budhathoki, Joy Dunkers, Joe Chalfoun, Peter Bajcsy, Carl Simon Jr.
In the field of tissue engineering, 3D scaffolds and cells are often combined to yield constructs that are used as therapeutics to repair or restore tissue function in patients. Viable cells are required to achieve the intended mechanism of action for the

Biglycan regulates bone development and regeneration

February 16, 2023
Author(s)
Reut Shainer, Vardit Kram, Tina Kilts, Andrew Doyle, Inbal Shainer, Carl Simon Jr., Jinyang Zeng-Brouwers, Liliana Schaefer, Marian Young
Endochondral bone development and regeneration relies on activation and proliferation of periosteum derived cells (PDCs). Biglycan (Bgn), an extracellular matrix component, is known to be expressed in bone and cartilage, however little is known about its

Orthogonal and complementary measurements of properties of drug products containing nanomaterials

January 6, 2023
Author(s)
Bryant C. Nelson, Elijah Petersen, Carl Simon Jr., Sven-Even Borgos, Luigi Calzolai, Jeremie Parot, Matthias Roesslein, Fanny Caputo, Xiaoming Xu
Quality control of pharmaceutical and biopharmaceutical products, and verification of their safety and efficacy, depends on reliable measurements of critical quality attributes (CQAs). The task becomes particularly challenging for drug products and

Measuring Dimensionality of Cell-Scaffold Contacts of Primary Human Bone Marrow Stromal Cells Cultured on Electrospun Fiber Scaffolds

January 1, 2023
Author(s)
Carl Simon Jr., Peter Bajcsy, Joe Chalfoun, Michael Paul Majurski, Mary C. Brady, Mylene Simon, Nathan Hotaling, Nick Schaub, Allison Horenberg, Piotr Szczypinski, Dongbo Wang, Veronica DeFelice, Soweon Yoon, Stephanie Florczyk
The properties and structure of the cellular microenvironment can influence cell behavior. Sites of cell adhesion to the extracellular matrix (ECM) initiate intracellular signaling that direct cell functions such as proliferation, differentiation and

Quantitative Determination of Cell Viability Using Absorbance Microscopy

January 19, 2022
Author(s)
Greta Babakhanova, Stephen Zimmerman, Laura Pierce, Sumona Sarkar, Nicholas Schaub, Carl Simon Jr.
Cell viability is an essential measurement for cell therapy products. One of the most common tests is Trypan blue (TB) dye exclusion where blue-stained cells are counted via imaging. Typically, live and dead cells are counted based on pixel intensities of

AbsorbanceQ: An App for Generating Absorbance Images from Brightfield Images

January 4, 2022
Author(s)
Stephen Zimmerman, Carl Simon Jr., Greta Babakhanova
The AbsorbanceQ app converts brightfield microscope images into absorbance images that can be analyzed and compared across different operators, microscopes and time. Absorbance-based measurements are comparable, which is useful when the aim is to

Tissue Engineering Measurands

August 26, 2020
Author(s)
Greta Babakhanova, Carl Simon Jr., 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

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 Jr., 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