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Minerva Biolabs

[Minerva Biolabs] 10CFU® Mycoplasma pneumoniae

Cat-No. 105-4001



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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10CFU® Mycoplasma pneumoniae



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105-4001



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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 pneumoniae is a human-associated mycoplasma species and is phylogenetically related to other clinically relevant human mycoplasmas. The 10CFU® Mycoplasma pneumoniae standard is therefore particularly suitable for risk-based validation of NAT-based mycoplasma testing in human cell culture and biopharmaceutical manufacturing processes.

Specification

Product category10CFU® Mycoplasma Standards
SpeciesMycoplasma pneumoniae
Sample typeInactivated mycoplasma particles (DNA/RNA-containing)
NCTC code10119
ATCC code15531
ApplicationNAT-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 complianceEP 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
Storage2-8 °C
ShippingAmbient temperature
Shelf lifeSee package labeling

More Available Species

Cat. No. 105-1001: Mycoplasma arginini
Cat. No. 105-2001: Mycoplasma orale
Cat. No. 105-3001: Mycoplasma gallisepticum
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

 


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