Quality Control
The quality control (QC) tests, indicated as ”Standard QC”, will be performed and documented during each manufacturing process and are included in the basic manufacturing price.
Standard QC
| No. | Test | Analytical Method |
|---|---|---|
1 |
Appearance |
Visual inspection |
2 |
DNA-concentration |
UV-Absorption (260 nm) |
3 |
DNA Purity |
UV-Scan (220 – 320 nm) |
4 |
Plasmid identity (1 enzyme, additional on request) |
Restriction digestion and AGE |
5 |
RNA |
Visual inspection after AGE |
6 |
DNA homogeneity (ccc monomer content) |
Densitometry after AGE |
7 |
Endotoxin (LPS) |
LPS assay |
AGE: agarose gel electrophoresis
ccc: covalently closed circular - supercoiled plasmid topology for the highest expression efficacy
Extended QC
| No. | Test | Analytical Method |
|---|---|---|
8 |
Bacterial chromosomal DNA |
Visual inspection after AGE |
9 |
Endotoxin (LPS) |
Quantitative LPS assay |
10 |
DNA homogeneity (total ccc content) |
Capillary Gel Electrophoresis (CGE) |
Additional QC options
| No. | Test | Analytical Method |
|---|---|---|
11 |
Bacterial chromosomal DNA |
Quantitative Real-Time-PCR |
12 |
Protein |
BCA assay (Bicinchoninic Acid) |
13 |
Purity (microorganism): Microbial Enumeration Tests* |
TAMC/TYMC |
14 |
Identity |
Sequencing |
15 |
Host Cell Protein |
ELISA |
*TAMC/TYMC according to EP, Ph. Eur., 6th Ed., Chapt. 2.6.12 and USP <61>
ATTENTON: Microbial Enumeration Tests require a part of the ordered DNA and additional purification steps are necessary. Please take this into account when ordering this QC. If you have any questions regarding this, please contact us.
The QC tests are performed according to documented procedures. Further QC test are available on request. Do not hesitate to contact us.
