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Determination of the extent of deamidation of TNK-tPA products.
| Deamidation / Products | N 58 (T8) | N 184 (T17) |
|---|---|---|
| Innovator | 13 (±2) % | 29 (±4) % |
| Follow-on | 28 (±3) % | 48 (±5) % |
Deamidated tryptic peptides and sites:
T8 (56–82): CFNGGT(Fu)CQQALYFSDFVCQCPEGFAGK (N58)
T17 (163–189): YSSEFCSTPACSEGNSDCYFGN(non-glycol)GSAYR (N184)
Average of 5 measurements
