Remove Clinical Development Remove Packaging Remove Protein Production
article thumbnail

Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input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

article thumbnail

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. The real cost is clinical development.