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

Endotoxine (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.