100GC® Mycoplasma Standards are non-infectious reference materials for matrix-specific validation of PCR-based mycoplasma tests.
- Compliant with EP 2.6.7 (12.2)
- Ready-to-use 100 GC/ml standards for reliable matrix-specific validation
- Non-infectious and regulatory safe
Mycoplasmas represent one of the greatest contamination risks in cell
cultures and in biopharmaceutical production (e.g. ATMPs). European
Pharmacopoeia (EP) 2.6.7 requires a validated test method for the
release of such products, capable of detecting both culturable and
non-culturable mycoplasmas. Nucleic acid amplification techniques (NAT)
have become the new gold standard, as they reliably detect both forms.
The previously applied sensitivity limit of 10 CFU/ml was based on
classical culture methods.
With the new edition 12.2 of EP 2.6.7, the requirements change: For
PCR methods, a sensitivity limit of less than 100 genome copies/ml
(GC/ml) is introduced. This PCR-appropriate unit is considered practical
for PCR laboratories and has long been expected as a standard for
determining the detection limit.
Our 100GC® Mycoplasma Standards are specifically designed to meet
these new requirements. They are non-infectious and therefore safe to
handle, titrated to 100 GC, and comply with the new regulatory guideline
for NAT standards. The standards are lyophilized and ready to use after
reconstitution. In addition, the standards can be used as an external
positive control with defined concentration, fulfilling all new
regulatory requirements.
Optionally, 10 CFU/ml standards remain available for comparability with classical culture methods.
| Application |
Mycoplasma detection |
|---|
| Use cases |
- Method validation according to EP 2.6.7
- External positive control for mycoplasma testing
- QC batch release and routine testing
|
| Contents |
- 3 vials each containing 100 GC (lyophilized)
- 1 vial PCR-grade water
|
| Detection method |
- PCR
- real-time PCR (qPCR)
- digital PCR (dPCR/ddPCR™)
|
| Compliance |
EP 2.6.7 |
Required equipment
& consumables |
- PCR thermal cycler
- PCR reaction tubes
- Centrifuge for 1.5 mL PCR tubes
- Pipettes
- Mycoplasma detection kit
|
Concentration after
reconstitution |
100 GC/ml |
| Sample type |
RNA-containing DNA standard |
| Storage |
2-8 °C |
| Shipping |
Ambient temperature |
| Shelf life |
See expiration date on package |
If you cannot find the answer to your problem then please contact us or telephone +44 (0)1954 210 200