New Product Launch | Yeasen: Compliant, Fast, and Versatile Mycoplasma qPCR Kit (2G)

In recent years, with the rapid development of biopharmaceuticals and the emergence of cell and gene therapies as well as mRNA vaccines during the pandemic, ensuring the safety and reliability of biological products has become a key focus and regulatory priority for governments and regulatory bodies worldwide. Mycoplasma is a common but often difficult-to-eliminate type of contamination. For bioprocesses involving cell culture, regulations require that 'there must be no mycoplasma contamination.

Points for Mycoplasma testing required by regulatory bodies

2.1 Cross-reactivity:

DNA from 14 strains of non-flexibacterial phyla and 6 engineering cells commonly used in biomedicine were selected, and none of the target channels peaked and the internal reference amplified normally.

Test Species

Staphylococcus epidermidis

Pseudohyphae

Clostridium perfringens

Salmonella enterica Enteritidis subsp. enterica

Clostridium acetobutylicum

Bacillus subtilis (bacillus subtilis)

Acinetobacter baumannii (immobile bacteria)

Bacillus cereus

Lactobacillus acidophilus

HEK293

Enterobacter aerogenes (taxonomic class of bacteria)

Vero

Micrococcus garciniae

CHO

streptococcus mutans

E.coli

Pseudomonas aeruginosa

HEK293T

Streptococcus pneumoniae

Sf9


2
.2 Some of the data are as follows:

  • Detection Limit

Nucleic acid extraction and detection of 10CFU/mL Mycoplasma standard strains were performed according to the instructions of the standard strains and the extraction and detection kits.

The NCS and NTC samples were tested at the same time in each experiment, and the results of 24 replicate wells of 10CFU/mL samples of each strain met the requirement that ≥23 of the 24 tests were positive when the NCS and NTC results were satisfactory.

Table 1 Information on validated strains

Serial No.

Mycoplasma name

Concentration of bacterial liquid

1

Mycoplasma arginini

10 CFU/mL

2

Mycoplasma orale

10 CFU/mL

3

Mycoplasma gallisepticum

10 CFU/mL

4

Mycoplasma pneumoniae

10 CFU/mL

5

Mycoplasma synoviae

10 CFU/mL

6

Mycoplasma fermentans

10 CFU/mL

7

Mycoplasma hyorhinis

10 CFU/mL

8

Acholeplasma laidlawii

10 CFU/mL

9

Spiroplasma citri

10 CFU/mL

10

Mycoplasma salivarium

10 CFU/mL

Table 2 Detection limit results

10 CFU/mL

Experiment 1

Experiment 2

Experiment 3

Detection Rate

8/8

8/8

8/8

Total

24/24

 

Product Information

Product

Catalog Number

Product Name

product specification

Sample pretreatment kit

18461ES

MolPure® Magnetic Residual DNA Sample Preparation Kit

25T/100T

18467ES

MolPure® Mag48 Sample Preparation Kit FN

3Ă—16T/ 6Ă—16T

Nucleic acid extraction instrument

80511ES

48-Channel Automated Nucleic Acid Extractor

48 Channel

Mycoplasma Detection Kit

40619ES

MycAway® Mycoplasma Real-time qPCR Detection Kit (2G)

25T/100T

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