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Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Agency IQ

Cell-based assays , while more complex to develop and use, offer another option for characterizing product activity at a slightly higher level, allowing sponsors to measure the further downstream effects of products (e.g., morphological cell changes or alterations in protein production or expression).

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Codon Digest: Bacteria Resist Every Virus

Codon

🧪 Papers AI + Bio Protein-specific signal peptides for mammalian vector engineering. Evolutionary-scale prediction of atomic-level protein structure with a language model. Biological Engineering Generation of functional oocytes from male mice in vitro. Metabolic Engineering. Metabolic Engineering.

Virus 52
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Beyond Steel Tanks

Codon

In the first real test of delivering a complex biomolecule to over a billion people, little has changed from how Genentech first approached manufacturing in the 1980s; Cells are genetically engineered and then grown in steel tanks. To make matters worse, many companies struggled with engineering problems on the path to scale.

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Elasmogen announces a panel of novel, potent, anti-COVID-19 therapeutic candidates identified through collaboration with U.S. research partners

The Pharma Data

Dr Caroline Barelle (CEO and CSO, Elasmogen Ltd) explained: “These robust little proteins have their origins in the immune systems of sharks and over 400 million years of evolution have been tailor-made to recognise pockets and grooves in proteins as part of the animals defence against infections.