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U.S. FDA laws, regulations and guidance

WEBCellular & Gene Therapies (CGTs) are complex products, which have been key foci of the International Society for Cell & Gene Therapy (ISCT). For this ISCT North American …

Actived: 1 days ago

URL: https://www.isct-cytotherapy.org/article/S1465-3249(19)30387-1/fulltext

Review of flow cytometry as a tool for cell and gene therapy

WEBQuality control testing and analytics are critical for the development and manufacture of cell and gene therapies, and flow cytometry is a key quality control and …

Category:  Health Go Health

Tumorigenicity assessment of cell therapy products: The need for …

WEBPluripotent stem cells offer the potential for an unlimited source for cell therapy products. However, there is concern regarding the tumorigenicity of these products in humans, …

Category:  Health Go Health

The harmonization of World Health Organization International

WEBThe World Health Organization (WHO) assigns International Nonproprietary Names (INN) to pharmaceutical substances, including advanced therapy medicinal products, to …

Category:  Health Go Health

Medical societies, patient education initiatives, public debate and

WEBBusinesses marketing unproven stem cell interventions proliferate within the U.S. and in the larger global marketplace. There have been global efforts by scientists, …

Category:  Health Go Health

Current state of Health Canada regulation for cellular

WEBWe provide an overview of the regulatory framework, pathways and underlying regulatory authority for cell, gene and tissue-engineered therapies in Canada. …

Category:  Health Go Health

Current state of Health Canada regulation for cellular and …

WEBCurrent state of Health Canada regulation for cellular and gene therapy products: potential cures on the horizon JOLENE CHISHOLM1,2,*, CRYSTAL RUFF3,4,5,* & SOWMYA …

Category:  Health Go Health

Optimal umbilical cord blood collection, processing and

WEBW. Bill Young Cell Transplantation Program to treat patients who need a UCB transplant (https://bloodstemcell.hrsa.gov/about/con tracts/national-cord-blood-inventory-contract …

Category:  Health Go Health

Stem cell therapy in the Philippines

WEBThe Department of Health and Food Drug Administration is currently preparing the guidelines for the applications of Stem Cell therapy in the Philippines. Massive …

Category:  Food Go Health

An assessment of the hospital exemption landscape across …

WEBThe exact meaning of specific terms used within the HE criteria, in particular non-routine and specificqualitystandards, has been subject to divergent interpretation across …

Category:  Health Go Health

Stem cell-derived exosomes in bone healing: focusing on their …

WEBTo this end, stem cell-derived exosomes with angiogenic potency have been developed to improve fracture healing. This review summarizes the effects of stem cell-derived …

Category:  Health Go Health

Cell and gene therapy manufacturing capabilities in Australia and …

WEBThe term “cell therapy,” as commonly used, refers to the treatment of patients with cells, tissues or organs that have been prepared and administered for the purpose of treating …

Category:  Health Go Health

CAR-T cell therapy in India requires a paradigm shift in training

WEBChimeric antigen receptor (CAR)-T cell therapy has revolutionized the treatment of some kinds of cancers. Hundreds of companies and academic institutions …

Category:  Cancer Go Health

Assessment and comparison of viability assays for cellular …

WEBAccurate assessment of cell viability is crucial in cellular product manufacturing, yet selecting the appropriate viability assay presents challenges due to …

Category:  Health Go Health

Comparison of regulatory pathways for the approval of …

WEBtemporal variables was made only for common ATMPs approved in both regions. A two-tailed significance was set at a level of 0.05. The statistical analysis was performed …

Category:  Health Go Health

Comparison of new Brazilian legislation for the approval

WEBAdvanced therapy medicinal products (ATMPs) are a class of biological products for human use that are based on genes, cells and tissues. The first ATMP …

Category:  Health Go Health

Assessment and comparison of viability assays for cellular …

WEBBackground aims: Accurate assessment of cell viability is crucial in cellular product manufacturing, yet select-ing the appropriate viability assay presents challenges due to …

Category:  Health Go Health

Cell and gene therapy products in Malaysia: a snapshot of the …

WEBCell and gene therapy products (CGTPs) are anticipated to bring many benefits for the treatment of conditions with limited or no satisfactory treatment options. …

Category:  Health Go Health

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