|Place of Origin:||China, Shanghai|
|Certification:||NQA ISO 9001:2015|
|Model Number:||CAS: 9002-07-7|
|Minimum Order Quantity:||100mg|
|Packaging Details:||10mg, 100mg, 1g; ice packaging, carton|
|Supply Ability:||10g per day|
|Molecular Weight(SDS-PAGE):||24.0±2.4 KDa||Usage:||Vaccine Production|
cell culture 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
|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 conditions expected.
Contact Person: Miss Eland