| Category | Testing Item | BRC Method | Regulatory Compliance |
|---|---|---|---|
| Viability | Cell Vialbility | Cell Counting | |
| Cell Morphylogy | Microscopic Examination | ||
| Identity | CO1 Barcoding | Multiplex PCR Sanger Seqencing |
USP, EP, ChP |
| Purity | Sterility |
Direct Inoculation Method Membrane Filtration Method Rapid Ster |
USP, EP, ChP |
| Mycoplasma |
Agar & Non-agar Cultivation qPCR Rapid Testing |
USP, EP, ChP | |
| Mycobacterium |
in vitro Indicate Cell-based Assay in vivo Assay NGS-based Assa |
||
| Safety | Adventitious Viruses | in vitro Indicate Cell-based Assay in vivo Assay NGS-based Assa |
USP, EP, ChP |
| Retrovirus | Cell-based Infectivity Assay Transmission Electron Microscopy (TEM) PERT Assay |
USP, EP, ChP | |
| Rodent-specific Pathogens |
Antibody Production Test (MAP, HAP, RAP) Rodent Pathogen qPCR Panel Targeted NGS* |
USP, EP, ChP | |
| Bovine & Porcine Pathogens |
Cell-based Infectivity Assay Bovine & Porcine Pathogens qPCR Panel |
9CFR | |
|
* NGS-based Assay and Targeted NGS are conducted on BRC NGenius®
Platform
|
|||
What type of antibody expression systems and products can you evaluate?
Since E. coli used for plasmid production is a live culture, the viability of the bacterial bank directly affects the production performance of plasmid products and the passage stability of the manufacturing. According to FDA guidance (Recommendations for Microbial Vectors used for Gene Therapy), bacterial viability in the bank must be no less than 60%, and viability must be explicitly determined for both the Master Cell Bank (MCB) and the Working Cell Bank (WCB). Plate dilution methods or flow cytometry are recommended for measuring bacterial viability.
What type of antibody expression systems and products can you evaluate?
Since E. coli used for plasmid production is a live culture, the viability of the bacterial bank directly affects the production performance of plasmid products and the passage stability of the manufacturing. According to FDA guidance (Recommendations for Microbial Vectors used for Gene Therapy), bacterial viability in the bank must be no less than 60%, and viability must be explicitly determined for both the Master Cell Bank (MCB) and the Working Cell Bank (WCB). Plate dilution methods or flow cytometry are recommended for measuring bacterial viability.
What type of antibody expression systems and products can you evaluate?
Since E. coli used for plasmid production is a live culture, the viability of the bacterial bank directly affects the production performance of plasmid products and the passage stability of the manufacturing. According to FDA guidance (Recommendations for Microbial Vectors used for Gene Therapy), bacterial viability in the bank must be no less than 60%, and viability must be explicitly determined for both the Master Cell Bank (MCB) and the Working Cell Bank (WCB). Plate dilution methods or flow cytometry are recommended for measuring bacterial viability.
What are viability tests?
Since E. coli used for plasmid production is a live culture, the viability of the bacterial bank directly affects the production performance of plasmid products and the passage stability of the manufacturing. According to FDA guidance (Recommendations for Microbial Vectors used for Gene Therapy), bacterial viability in the bank must be no less than 60%, and viability must be explicitly determined for both the Master Cell Bank (MCB) and the Working Cell Bank (WCB). Plate dilution methods or flow cytometry are recommended for measuring bacterial viability.
