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100CFU® Mycoplasma fermentans (Illustration similar or symbolic)
Illustration similar or symbolic

100CFU® Mycoplasma fermentans

100CFU® Mycoplasma Standards are inactivated, lyophilized mycoplasma particles suitable for method validation and for use as an External Positive Control in NAT-based mycoplasma testing.
- EP 2.6.7 (12.2), USP <77>, and JP 18 G3 compliant
- ≤100 CFU/ml, <10 GC:CFU
- Non-infectious, lyophilized

Cat. No.: 106-6001

€690.00
Tax excluded excl. Shipping costs
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Manual.pdf
Compliance Information.pdf
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Product Description

Mycoplasma contamination represents one of the major 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 reliably detecting both cultivable and non-cultivable mycoplasma.

100CFU® Mycoplasma Standards were specifically developed to meet these regulatory requirements and are particularly intended for use as an External Positive Control (EPC). 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 robust assessment of assay performance under routine conditions and to support Limit of Detection (LOD) determination.

Application-Specific Relevance

Mycoplasma fermentans is a human-associated mycoplasma species and has been repeatedly reported as a contaminant in human cell culture systems. The 100CFU® Mycoplasma fermentans standard is therefore particularly relevant for manufacturing processes involving human cell substrates and supports matrix-specific assessment of potential contamination risks in human cell culture and biopharmaceutical production processes.

Specification

Product category 100CFU® Mycoplasma Standards
Species Mycoplasma fermentans
Sample type Inactivated mycoplasma particles (DNA/RNA-containing)
NCTC code 10117
ATCC code 19989
Application NAT-based mycoplasma testing
Application areas
  • Method validation
  • External positive control
  • Assay performance evaluation
  • QC release and routine testing
Regulatory compliance EP 2.6.7 (12.2), USP <77>, JP 18 G3
Contents
  • 3 vials ≤100 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 ≤100 CFU/ml
Storage 2-8 °C
Shipping Ambient temperature
Shelf life See package labeling

More Available Species

Cat. No. 106-1001: Mycoplasma arginini
Cat. No. 106-2001: Mycoplasma orale
Cat. No. 106-3001: Mycoplasma gallisepticum
Cat. No. 106-4001: Mycoplasma pneumoniae
Cat. No. 106-5001: Mycoplasma synoviae
Cat. No. 106-7001: Mycoplasma hyorhinis
Cat. No. 106-8001: Acholeplasma laidlawii
Cat. No. 106-9001: Spiroplasma citri
Cat. No. 106-1101: Mycoplasma salivarium