Drug Discovery World

JANUARY 10, 2024

These therapies, which exhibit substantial long-term side effects, including genotoxicity and an increased predisposition to secondary cancers, have significantly higher rates of subsequent malignancies than the rate reported for patients following CAR-T cell immunotherapies.

Gene Therapy 57

Gene Therapy Genotoxicity Gene Genetics 57

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.

Development 130

Development Manufacturing Production Vaccination 130

Drug Discovery World

MAY 10, 2023

This stage is more highly regulated and consists of both preclinical testing and clinical trials. Specific guidelines set forth to regulate these testing processes are issued by the ICH, a non-profit organisation with representation from global regulatory agencies and pharmaceutical companies.

Bioassay 52

Bioassay Genotoxicity Drugs In-Vivo 52

The Pharma Data

MAY 13, 2021

The trans-fat ban–food regulation and long-term health. Exposure to sorbitol during lactation causes metabolic alterations and genotoxic effects in rat offspring. Regulation of glucose metabolism from a liver-centric perspective. The role of ghrelin in weight-regulation disorders: implications in clinical practice.

Insulin 52

Insulin Production Hormones Medicine 52