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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

Where the bottlenecks of achieving higher cell density and higher titers were once thought to be issues of the past, hurdles have now shifted to achieving speed and scale in mAb production without sacrificing quality.

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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.

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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

It is packaged in a ready-to-use liquid formulation in 10-dose vials. The company’s proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. efficacy against the B.1.351