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10CFU® Mycoplasma orale (Illustration similar or symbolic)
Illustration similar or symbolic

10CFU® Mycoplasma orale

10CFU® Mycoplasma Standards are inactivated, lyophilized mycoplasma particles for product- and matrix-specific validation of NAT-based mycoplasma tests.
- EP 2.6.7 (12.2), USP <77>, and JP 18 G3 compliant
- ≤10 CFU/ml, <10 GC:CFU
- Non-infectious, lyophilized

Cat. No.: 105-2001

€429.00
Tax excluded excl. Shipping costs
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Manual.pdf Manual.pdf
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Product Description

Mycoplasma contamination represents one of the most critical risks in cell culture systems and biopharmaceutical manufacturing, including ATMPs. The European Pharmacopoeia (EP) 2.6.7, the United States Pharmacopeia (USP) <77>, and the Japanese Pharmacopoeia (JP) 18 G3 require validated test methods capable of detecting both cultivable and non-cultivable mycoplasma.

10CFU® Mycoplasma Standards were specifically developed to meet these regulatory requirements. Manufactured in accordance with EP 2.6.7 (edition 12.2), the standards are non-infectious and safe to handle. After reconstitution, defined quantities of the standard are spiked into the respective product or sample matrix to enable Limit of Detection (LOD) determination and use as an External Positive Control (EPC) with a defined concentration.

Application-Specific Relevance

Mycoplasma orale is among the most frequently reported contaminants of human cell lines. The 10CFU® Mycoplasma orale standard is therefore particularly suitable for risk-based validation of NAT-based mycoplasma testing in human cell culture and vaccine manufacturing processes.

Specification

Product category 10CFU® Mycoplasma Standards
Species Mycoplasma orale
Sample type Inactivated mycoplasma particles (DNA/RNA-containing)
NCTC code 10112
ATCC code 23714
Application NAT-based mycoplasma testing
Application areas
  • Method validation
  • Test for Inhibitory Substances (EP 2.6.7)
  • Method Suitability Test (USP <77>)
  • External positive control
  • QC release and routine testing
Regulatory compliance EP 2.6.7 (12.2), USP <77>, JP 18 G3
Contents
  • 3 vials ≤10 CFU (lyophilized)
  • 1 vial PCR-grade water
Detection method
  • PCR
  • real-time PCR (qPCR)
  • digital PCR (dPCR/ddPCR™)
Required equipment
& consumables
  • PCR reaction tubes
  • Centrifuge for 1.5 ml PCR reaction tubes
  • Pipettes
  • Mycoplasma detection kit
Concentration ≤10 CFU/ml
Storage 2-8 °C
Shipping Ambient temperature
Shelf life See package labeling

More Available Species

Cat. No. 105-1001: Mycoplasma arginini
Cat. No. 105-3001: Mycoplasma gallisepticum
Cat. No. 105-4001: Mycoplasma pneumoniae
Cat. No. 105-5001: Mycoplasma synoviae
Cat. No. 105-6001: Mycoplasma fermentans
Cat. No. 105-7001: Mycoplasma hyorhinis
Cat. No. 105-8001: Acholeplasma laidlawii
Cat. No. 105-9001: Spiroplasma citri
Cat. No. 105-1101: Mycoplasma salivarium