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Early phase support for plasmid DNA supply to secure future manufacturing

Drug Discovery World

This paid-for advertorial by Catalent appeared in DDW Volume 24 – Issue 1, Winter 2022/2023 One significant challenge in the manufacturing of cell and gene therapies is the production of high-quality plasmid DNA (pDNA). Figure 1: The integrated development pathway for cell and gene therapies.

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Article FDA Thank You The next chapter in the ctDNA story: Still promising, not ready for prime time

Agency IQ

The next chapter in the ctDNA story: Still promising, not ready for prime time A recent workshop summed up the state of play for circulating tumor DNA. subsequent superior/inferior supportive care, lifestyle changes, and/or use of additional therapies). years before they would have been available otherwise.

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Advances in cell line development

Drug Discovery World

The market for cell line development is currently rising due to an increased focus by the life sciences sector on biopharmaceuticals and targeted therapies. According to Grand View Research, the global cell line development market was valued at $4.81 There are a lot of considerations to take when choosing a cell line.

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The path to improved safety of gene-based products

Drug Discovery World

Kerstin Pohl , Senior Global Marketing Manager, Gene Therapy & Nucleic Acid at SCIEX, looks at the application of liquid chromatography-mass spectrometry for analysing host cell proteins. In addition, their cumbersome developmental process limits their use for fast-tracked new modalities, such as DNA-based vaccines. 2022): 947.

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Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

Additionally, the plan aims to improve the quality of life for the over 12 million cancer survivors who benefited from earlier detection, effective therapies and supportive care. Briefly addressing companion diagnostics, the guideline advises that sponsors consider co-development of a companion diagnostic and the medicinal product.