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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. All packaged foods served or sold on transportation carriers (e.g., 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., 1, 2023, sesame.

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BE labeling Rule Challenge Largely Fails but Court Takes Issue with Electronic and Text Message Disclosure Options

FDA Law Blog

Plaintiffs challenged the use of the term bioengineered (rather than GMO or genetically engineered), the limitation of the mandatory disclosure being required only if the food contains detectable modified genetic material and the options of using a QR code disclosure or a text message for the disclosure statement.

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How single-use technologies can improve antibodies production  

Drug Discovery World

This means we are able to hijack the cell machinery to be even more efficient than before to produce more of what we want (mAb) and less of what we don’t want (impurities) through the different genetic editing tools for cell engineering.

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Novavax COVID-19 vaccine demonstrates 90% overall efficacy and 100% protection against moderate and severe disease in PREVENT-19 Phase 3 trial

The Pharma Data

“These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.

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Overcoming inefficiencies to improve access to cell and gene therapy 

Drug Discovery World

They can manufacture the drug substance and then pass it to a specialised fill-finish facility that will load it into its final sterile packaging.   Conversely, cell therapy manufacturing starts with a highly heterogeneous source material: human blood. Genetic Engineering & Biotechnology News. August 2020. April 4, 2022.