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Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input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: Discovering Antibiotics with Deep Learning

Codon

This week: A way to measure a transgene’s expression in the brain using ultrasound, a DNA sequencing method that uses 1000x less reagents, and base editors get even smaller. An engineered version of this protein can convert DNA bases with efficiencies up to 92%. so this Digest will be published more irregularly.

DNA 52
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Codon Digest: Discovering Antibiotics with Deep Learning

Codon

This week: A way to measure a transgene’s expression in the brain using ultrasound, a DNA sequencing method that uses 1000x less reagents, and base editors get even smaller. An engineered version of this protein can convert DNA bases with efficiencies up to 92%. so this Digest will be published more irregularly.

DNA 52
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Beyond Steel Tanks

Codon

In the case of semaglutide, those cells are Saccharomyces cerevisiae— also known as Baker’s yeast — engineered to secrete a peptide precursor that is later purified, chemically modified, packaged into an injectable or tablet form, and then shipped around the world. Continuing this method may not scale.