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Minerva Biolabs

[Minerva Biolabs] 100CFU® Mycoplasma salivarium

Cat-No. 106-1101



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 salivarium



제품 번호

 

106-1101



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 salivarium is a human-associated mycoplasma species and part of the normal oral microbiota. It may occur as a contaminant in human cell culture systems. The 100CFU® Mycoplasma salivarium standard is therefore particularly relevant for manufacturing processes involving human cell substrates and supports matrix-specific assessment of potential contamination risks.

Specification

Product category100CFU® Mycoplasma Standards
SpeciesMycoplasma salivarium
Sample typeInactivated mycoplasma particles (DNA/RNA-containing)
NCTC code10113
ATCC code23064
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. 106-6001: Mycoplasma fermentans
Cat. No. 106-7001: Mycoplasma hyorhinis
Cat. No. 106-8001: Acholeplasma laidlawii
Cat. No. 106-9001: Spiroplasma citri



Minerva Biolabs의 모든 제품을 만나보세요!


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