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Minerva Biolabs

[Minerva Biolabs] Venor® Mycoplasma qPCR

Cat-No. 111-9025



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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Venor® Mycoplasma qPCR



제품 번호

 

111-9025



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Product Description

Mycoplasmas are among the most significant contamination risks in cell culture and biopharmaceutical manufacturing (e.g., ATMPs). EP 2.6.7 requires a validated testing method for the release of such products.

The Venor® Mycoplasma qPCR Kit is specifically designed for use in QC and GMP laboratories. Compared to classical culture methods, it reduces detection time from several weeks to ≤ 3 hours and enables reliable release testing of biopharmaceuticals and ATMPs. The PCR-based method offers the advantage of detecting both culturable and non-culturable mycoplasmas, making it superior to traditional culture tests.

Detection is based on amplification of a highly conserved 16S rRNA coding region in the mycoplasma genome, enabling reliable identification of all mycoplasma, acholeplasma, and spiroplasma species listed in EP 2.6.7, as well as over 130 additional mollicutes. By combining reverse transcriptase and DNA polymerase, both RNA (as cDNA) and DNA are amplified, significantly increasing sensitivity. The assay has been validated according to current regulatory requirements EP 2.6.7 (Edition 12.2) and in compliance with ICH Q2(R2), meeting criteria for specificity, robustness, and sensitivity with detection limits of ≤ 10 CFU/ml and < 100 GC/ml. Positive control as well as internal and process controls further ensure the reliability of results and provide maximum security in routine testing.

The external positive control with defined concentration, as required by the new EP 2.6.7, can be obtained directly from us. Our 100GC® Mycoplasma Standards serve both as reference material for validation and as an external positive control in routine testing.

Specifications

ApplicationMycoplasma detection
Application areas
  • QC release of biopharmaceuticals and ATMPs
  • QC of cell cultures
Contents
  • Mycoplasma Mix (lyophilized)
  • Positive Control (lyophilized)
  • Internal Control (lyophilized)
  • PCR grade Water
ComplianceEP 2.6.7
Validation reportavailable
PCR typeRT-qPCR
Compatible devicesqPCR cyclers
Detection limit (LOD)≤ 10 CFU/ml
< 100 GC/ml
Detection spectrum≥ 130 mollicutes
Control system
  • Positive control
  • Internal control
Number of reactions
  • 111-9025: 25 reactions
  • 111-9100: 100 reactions
Price per reaction
  • 111-9025: €31.96
  • 111-9100: €28.90
Required equipment
and consumables
  • qPCR cycler (FAM™ and HEX™ alternatively VIC™ or JOE™)
  • PCR tubes
  • centrifuge for 1.5 ml PCR tubes
  • pipettes
Storage2-8 °C; ≤ –18 °C after opening or rehydration
ShippingAmbient temperature
Shelf life (max.)18 months

 


Minerva Biolabs의 모든 제품을 만나보세요!


Cell Culture Contamination Control

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Pharma / ATMP

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