
GMP-Compliant Benzonase® Endonuclease Safety Plus Emprove® Expert Provides Enhanced Risk Mitigation
- GMP compliant manufacturing standards (ICH, Q7)
- Utilizes a origin chemically defined fermentation medium
- Additional quality testing to ensure absence of mycoplasma and adventitious viruses
- Tailgate samples facilitate incoming good control for large pack sizes adds a further layer of product safety
- Temperature strips on packages to monitor cold chain during shipping
Charactoristics | Standard Benzonase® endonuclease EMPROVE® Expert | New Benzonase® endonuclease Safety Plus EMPROVE® Expert |
---|---|---|
Origin | Serratia marcescens, Production: E. coli K12 strain W3110; 30 kDa; PI 6.85; sequence homology (LC-MS/MS) | |
Non-Animal-Origin (NAO), expressed in E.coli in chemically defined fermentation medium | No | Yes (animal-origin-free) |
Lot release in vitro test for absence of adventitious viruses (3 cell lines) and Mycoplasma test | No | Yes |
Lot release testing for Mycoplasma | No | Yes |
Tailgate samples | No | Yes (with 5M unit size) |
Shipment with temperature strips | No | Yes |
Microbial testing | < 10 CFU/100,000 U | < 10 CFU/100,000 U |
Endotoxins (LAL) | < 0.25 EU/1,000 U | < 0.25 EU/1,000 U |
GMP manufacturing according to ICH Q7 | Yes | Yes |
FDA Bulk Biological Master File (BBMF) | Yes | Yes |
Long term product availability | Both Benzonase® products will remain in our portfolio |