Recombinant Trypsin, Specific Activity ≥ 3800 USP units/mg pro., Impurity Free

Recombinant Trypsin, Specific Activity ≥ 3800 USP units/mg pro., Impurity Free

Recombinant Trypsin

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 detected annual.

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

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 conditions expected.