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Risk Assessment for use of Engineered Genetic Materials in Clinical Research

Advarra

This trend came to the forefront during the COVID-19 pandemic, as the three most popular vaccines developed in response to the coronavirus contained engineered genetic materials in the form of mRNA or a genetically engineered virus. Why Does the IBC Need to do a Risk Assessment?

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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. labeling of major food allergens in bulk foods, dietary supplements, protein-free ingredients, and foods produced through genetic engineering); and. 1, 2023, sesame.

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How Centralized IBC Review Can Benefit Gene Therapy Research

Advarra

Gene therapy research is booming in the clinical setting. In this blog, we summarize the growth, risks, and regulatory requirements for gene therapy research. We also discuss how a centralized biosafety review process can benefit this type of research.

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AstraZeneca-Oxford COVID-19 Vaccine Shows High Efficacy

XTalks

Developed by researchers at the University of Oxford, the COVID vaccine is an adenovirus vector-based vaccine derived from chimpanzees that contains a genetically engineered virus that causes the common cold in chimpanzees, along with the spike protein of the SARS-CoV-2 coronavirus.

Vaccine 97
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How Potential Changes to the NIH Guidelines Could Impact IBC Review

WCG Clinical

Originally released in 1976, the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules ( NIH Guidelines ) serve as the foundation of biosafety-focused oversight of research involving recombinant or synthetic nucleic acids (rsNA). Since then, however, certain genetic engineering technologies (e.g.,

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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.

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Pfizer/BioNTech COVID jab works against Brazil variant; lab study

pharmaphorum

The study suggests that serum taken from patients injected with the mRNA shot, also known as BNT162b2, was able to neutralise a genetically engineered version of SARS-CoV-2 with the P.1 The latest research is published in the New England Journal of Medicine. 1 – that is worrying health officials around the world. .