Drug Discovery World
JANUARY 10, 2024
ISCT, the global society of clinicians, researchers, regulators, technologists, and industry partners dedicated to the translation of cell and gene therapy (CGT) into safe and effective therapies to improve patients’ lives, aligns with the FDA in support of the need for thorough investigation and transparency.
Roots Analysis
MARCH 1, 2023
Genotoxicity testing refers to the evaluation of detrimental effects of chemical or physical agents on the genetic processes and related hereditary material of living cells. Mechanism of Genotoxicity / Mutagenicity The interaction of genotoxins / mutagens with the structure of DNA causes damage to the genetic material.
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Pharmaceutical Technology
DECEMBER 9, 2022
The move is particularly timely given the significant growth expected in global sales of cell and gene therapies. Dedicated experts in extractables and leachables and genotoxic impurities (GTIs) deploy organic trace analysis by liquid chromatography-mass spectrometry (LC-MS), as well as gas chromatography-mass spectrometry (GC-MS) equipment.
Drug Discovery World
MAY 10, 2023
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issues guidelines and develops testing strategies for evaluating carcinogenicity along with other risks such as genotoxicity, immunotoxicity, and reproductive toxicity.
The Pharma Data
MAY 13, 2021
Exposure to sorbitol during lactation causes metabolic alterations and genotoxic effects in rat offspring. Opiate-like effects of sugar on gene expression in reward areas of the rat brain. Proceedings of the National Academy of Sciences of the United States of America. 2012;109(16):5984-5988. DOI: 10.1073/pnas.1120794109. 1120794109.
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