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The agency identified concerns involving peptide-related impurities, aggregation and finished-product quality

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Limited proteolysis was performed by enzymatic digestion at 37 C adding bovine trypsin (Sigma-Aldrich, Italy) or proteinase K (Sigma-Aldrich, Italy) to protein extract at a ratio 1:100 enzyme/substrate (w/w)

A serial dilution of proteins from 500 to 50 ng from the PC3- hTERT cell line (telomerase-positive prostate cancer cell) was used to construct a standard curve of telomerase activity (supplementary data)

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