Impurity Profile of Recombinant Trypsin , Specific Activity ≥ 3800
USP units/mg pro.
Impurity compounds may originate from two different sources:
1) Residuals from the manufacturing process
Due to recombinant trypsin is produced with recombinannt E.coli, impurities from the manufacturing process are mainly from the
strain. Host cell protein and endotoxin are three main possible
impurities, the detection methods have been established and
These residuals are not influenced trypsin effect, and the content
is very limited.
2) Degradation products
Trypsin is easily self-degradated during the production process.
Specific activity is a critical purity criteria for enzymes. For
the recombinant trypsin, the specific activity is determined as NLT
3800 USP/mg pro, which is more higher than CP and USP trypsin
standard 2500 USP/mg of extracted trypsin from porcine or bovine
pancreas. And NLT 3800 USP/mg is a criteria of recombinant trypsin
on USP 39.
Impurity Profile of Recombinant Trypsin
|Impurities||Detection Method||Limited Content||Comments|
|Host cell proteins||ELISA||≤ 0.1%||Annual Test|
|Other protein impurities (media)||Specific Activity and SDS-PAGE|
≥ 3800 USP units/mg pro.
Single major band
Recombinant Trypsin have been validated for use in the manufacture
of therapeutics approved for human use. The materials of
construction have been in use for several decades.
For recombinant Trypsin, YaxinBio recommends that users undertake
characterization studies under the specific use and process