CRM197
CRM197 is a non-toxic mutant of diphtheria toxin used as a carrier protein carrier for polysaccharides and haptens enhancing their immunigenicity for vaccine applications.
To support its customers Xpress Biologics has developped a microbial expression system and a fully scalable industrial production process and provides High Quality recombinant CRM197
Production scale
Xpress Biologics recombinant CRM197 is produced as periplasmic protein using a proprietary E. coli BL21(T7) strain allowing milligrams for research to kilograms for commercial production.
Production Grade
- R&D : for in vitro and small animal assays
- GLP : for GLP preclinical assays
- GMP : for use in human (available in Q2 2022)
Product Sheet
| Tests | Control methods | Expected Values |
| Identity | SDS-PAGE in reducing conditions | Single band between 50-65 kDa |
| Western-Blot (WB) in reducing conditions | Single band between 50-65 kDa | |
|
RP-HPLC |
Rt similar to reference | |
| SE-HPLC | Rt similar to reference | |
| IEF | Single band between pI 5-6 | |
| Purity | SDS-PAGE in reducing conditions | > 95% CRM |
|
RP-HPLC |
> 95% CRM | |
| SE-HPLC | > 95% CRM | |
| Impurities | Residual E.coli host cell protein by WB | Absence of HCP bands |
| Residual E.coli host cell protein by ELISA | < 0.1% HCP | |
| Endotoxin content by LAL | < 20 EU/mg | |
| Genomic DNA quantification by qRT-PCR | < 0.1% w/w |