Isct-cytotherapy.org

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 …

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

The harmonization of World Health Organization International

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

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. Canada's regulatory …

Category: Health Go Health

Nonclinical and quality assessment of cell therapy products: …

WEBThe 4th Asia Partnership Conference of Regenerative Medicine (APACRM) was held online on April 15, 2021, to promote regulatory harmonization of regenerative medicine …

Category: Medicine 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

Background and Application of the HE Pathway

WEBHospital exemption (HE) is a regulated pathway that allows the use of advanced therapy medicinal products (ATMPs) within the European Union (EU) under …

Category: Health Go Health

Leukapheresis guidance and best practices for optimal …

WEBE-mail address: [email protected] (M. Qayed). optimal leukapheresis product is critical for the success of manufacturing; therefore, understanding factors that may affect the …

Category: Health Go Health

A consensus introduction to serum replacements and serum …

WEBIn the past several years, efforts were made both by academia and industry to develop serum replacements for cell culture. Such replacements are commonly called serum …

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

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

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

Comparison of guidelines for biological ancillary materials …

WEBregenerative medicine by establishing a dialogue between industries and health authorities to identify common challenges. It is also expected to help expedite distribution of these …

Category: Medicine 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

Quantitative analysis of composite umbilical cord tissue

WEBUmbilical cord (UC) tissue can be collected in a noninvasive procedure and is enriched in progenitor cells with potential therapeutic value. Mesenchymal stromal cells …

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 …

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

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

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