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IN FOCUS: Solvias

Pharmaceutical Technology

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.

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Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

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.