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100GC® Mycoplasma hyorhinis
100GC® Mycoplasma Standards are purified nucleic acid standards designed as reference material for product-specific validation of PCR-based mycoplasma testing methods.
- Compliant with EP 2.6.7 (12.2) and USP <77>
- Defined concentration of ≤100 GC/ml
- Suitable for product-specific validation and for use as EPC/EIC
- Optimized for PCR-based applications
Cat. no.: 104-7001
$463.00
Tax excluded
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Validation Guide
Validation Guide for 100GC® Mycoplasma hyorhinis
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Product Description
Mycoplasmas represent one of the greatest contamination risks in cell cultures and in biopharmaceutical production (e.g. ATMPs). The US Pharmacopoeia (USP) <63> 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.
The new USP <77> will change the requirements: For PCR methods, a sensitivity limit of 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 positve control with defined concentration, fulfilling all new regulatory requirements.
Optionally, 10 CFU/ml standards remain available for comparability with classical culture methods.
Application-Specific Relevance
Mycoplasma hyorhinis is a porcine-associated mycoplasma species and is frequently reported as a contaminant in cell culture systems. The 100GC® Mycoplasma hyorhinis standard is therefore particularly relevant for manufacturing processes involving porcine-derived materials as well as for human cell culture systems and supports matrix-specific assessment of potential contamination risks.
Specification
| Product category | 100GC® Mycoplasma Standards |
|---|---|
| Species | Mycoplasma hyorhinis (Mesomycoplasma hyorhinis) |
| Sample type | Purified mycoplasma nucleic acids (DNA/RNA-containing) |
| NCTC code | 10130 |
| ATCC code | 17981 |
| Application | Mycoplasma detection |
| Use cases |
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| Contents |
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| Detection method |
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| Compliance | EP 2.6.7 and USP <77> |
| Required equipment & consumables |
|
| Concentration after reconstitution |
100 GC/ml |
| Storage | 2-8 °C |
| Shipping | Ambient temperature |
| Shelf life | See expiration date on package |
More Available Species
Cat. No. 104-1001: Mycoplasma arginini
Cat. No. 104-2001: Mycoplasma orale
Cat. No. 104-3001: Mycoplasma gallisepticum
Cat. No. 104-4001: Mycoplasma pneumoniae
Cat. No. 104-5001: Mycoplasma synoviae
Cat. No. 104-6001: Mycoplasma fermentans
Cat. No. 104-8001: Acholeplasma laidlawii
Cat. No. 104-9001: Spiroplasma citri
Cat. No. 104-1101: Mycoplasma salivarium