Remove Containment Remove Genetic Engineering Remove Research
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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.

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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.,

Genome 52
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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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Novavax COVID-19 Vaccine Granted Fast Track Designation by U.S. FDA

The Pharma Data

President of Research and Development, Novavax. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

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mRNA Therapeutics and mRNA Vaccines Industry: Current Scenario and Future Trends

Roots Analysis

It is important in the process of protein synthesis because mRNA is responsible for transferring genetic information from DNA to ribosomes, which then decodes the genetic information into a protein. In the last few years, researchers have become interested in using in vitro transcribed (IVT) mRNA as a drug delivery agent.