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

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Displaying 1 - 25 of 136

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

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

February 29, 2020
Author(s)
Carl Simon Jr., 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

Comparison of Artificial Intelligence based approaches to cell function prediction

July 11, 2019
Author(s)
Sarala Padi, Petru S. Manescu, Nicholas Schaub, Nathan Hotaling, Carl G. Simon Jr., Peter Bajcsy
Predicting Retinal Pigment Epithelium (RPE) cell functions in stem cell implants using non-invasive bright field microscopy imaging is a critical task for clinical deployment of stem cell therapies. Such cell function predictions can be carried out either

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

forum Update May 31 2017

January 30, 2018
Author(s)
Carl G. Simon Jr.
Advanced Regenerative Manufacturing Institute (ARMI) The Department of Defense has announced an award of $80M to the non-profit Advanced Regenerative Manufacturing Institute (ARMI) located in Manchester, NH, led by Dean Kamen: www.armiusa.org. This award

Modeling, Validation and Verification of Three-Dimensional Cell-Scaffold Contacts from Terabyte- sized Images

December 1, 2017
Author(s)
Peter Bajcsy, Sowon Joy Yoon, Stephen Florczyk, Nathan Hotaling, Mylene H. Simon, Piotr Szczypinski, Nicholas J. Schaub, Carl G. Simon Jr., Mary C. Brady, Ram D. Sriram
Background: Cell-scaffold contact measurements are derived from pairs of co-registered volumetric fluorescent confocal laser scanning microscopy (CLSM) images (z-stacks) of stained cells and spun coat, large microfiber, and medium microfiber scaffolds. Our

3D Cellular Morphotyping of Cell Niches

August 31, 2017
Author(s)
Stephen J. Florczyk, Mylene H. Simon, Derek Juba, Patrick S. Pine, Sumona Sarkar, Desu Chen, Paula J. Baker, Subhadip Bodhak, Antonio Cardone, Mary C. Brady, Peter Bajcsy, Carl G. Simon Jr.
Three-dimensional (3D) cellular morphotyping is introduced for assessing and comparing the niches provided by biomaterial scaffolds. Many scaffold systems have been advanced to provide synthetic cell niches for tissue engineering and drug screening

FDA Approves First Genetically-Modified Cell Therapy to Treat Leukemia

March 1, 2017
Author(s)
Carl Simon Jr.
The FDA approved the first genetically-modified cell therapy for the treatment of leukemia on August 30, 2017 [1-2]. The treatment (tisagenlecleucel) is an "autologous genetically modified immunocellular therapy indicated for the treatment of pediatric and