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Risk Assessment for use of Engineered Genetic Materials in Clinical Research

Advarra

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. A key part of the IBC’s evaluation is assessing the risks posed by the engineered genetic materials.

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Researchers create new CRISPR tools to help contain mosquito disease transmission

Scienmag

Genetics toolkit targets less researched Culex mosquitoes, which transmit West Nile virus and avian malaria Credit: Gantz Lab, UC San Diego Since the onset of the CRISPR genetic editing revolution, scientists have been working to leverage the technology in the development of gene drives that target pathogen-spreading mosquitoes such as Anopheles and (..)

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This week in drug discovery (8-12 April) 

Drug Discovery World

The top stories: Genetically engineered dendritic cells enhance lung cancer therapy A study by researchers at the UCLA Health Jonsson Comprehensive Cancer Center in the US suggests that injecting engineered dendritic cells directly into cancerous lung tumours can help promote a stronger immune response.

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Kraft Heinz’s New Vegan Hot Dogs + How Precision Fermentation Could Revolutionize the Food Industry – Xtalks Food Podcast Ep. 151

XTalks

The products contain ingredients like bamboo fiber, pea protein and mushrooms. The study also highlights how genetically engineered microorganisms can inhibit the growth of foodborne pathogens. Additionally, the offerings have the distinctive “snap” of the outer casing and the savory smokiness of Oscar Mayer products.

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FDA Issues Two Guidance Documents on Food Allergen Labeling Requirements

FDA Law Blog

labeling of major food allergens in bulk foods, dietary supplements, protein-free ingredients, and foods produced through genetic engineering); and. Most notably, the draft guidance clarifies that the following food products are subject to the allergen labeling requirements: Bulk containers (e.g., 1, 2023, sesame.

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Safe Sharps Handling When Dispensing Investigational Products

Advarra

A loaded syringe can be safely capped using either: A safety engineered syringe. Tools or special sharp containers to remove the needle and replace with a fresh and already capped needle. All potentially infectious sharps must be disposed of in a biohazard sharps container immediately after use without recapping.

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Thinking About the Box: Considerations for Transport of Investigational Products

Advarra

Controlled Environment and IP Containment The potential for a release, and the risk associated with a genetically engineered IP, are part of the IBC’s assessment purview under National Institutes of Health (NIH) Guidelines. The containment must then prevent spills or leaks if the IP is dropped. Size matters.