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Minerva Biolabs

[Minerva Biolabs] 100CFU® Mycoplasma fermentans

Cat-No. 106-6001



Minerva Biolabs는 세포배양 및 바이오의약품에서의 mycoplasma, bacteria, virus를 검출/오염방지/제거 등 컨트롤할 수 있는 

고품질의 다양한 키트와 제품을 제공하는 독일 소재의 제조사입니다. 




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100CFU® Mycoplasma fermentans



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106-6001



제품 설명


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 category100CFU® Mycoplasma Standards
SpeciesMycoplasma fermentans
Sample typeInactivated mycoplasma particles (DNA/RNA-containing)
NCTC code10117
ATCC code19989
ApplicationNAT-based mycoplasma testing
Application areas
  • Method validation
  • External positive control
  • Assay performance evaluation
  • QC release and routine testing
Regulatory complianceEP 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
Storage2-8 °C
ShippingAmbient temperature
Shelf lifeSee 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

 


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