Venor® Mycoplasma qPCR

Venor® Mycoplasma qPCR
Product Description

Venor® Mycoplasma qPCR is a validated real-time RT-qPCR kit for the rapid, sensitive, and reliable detection of mycoplasma contamination in cell cultures, biopharmaceutical products, and advanced therapy medicinal products (ATMPs). The assay detects both RNA and DNA targets, providing enhanced sensitivity and robust detection performance for regulated quality control applications.

The kit is designed for easy handling and fast implementation in routine laboratory workflows. Lyophilized reagents simplify storage and logistics while reducing preparation time. Venor® Mycoplasma qPCR supports compliance with USP <63>, USP <77> draft, and current regulatory expectations for NAT-based mycoplasma testing.

The assay enables highly sensitive detection of more than 130 Mollicutes species and includes integrated Internal and Positive Controls to ensure assay reliability and result confidence.

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Minerva Biolabs GmbH

  • Country/Region:
    Germany
  • Founded:
    1999
  • On CPHI since:
    2026
  • Certificates:
    1
  • Employees:
    25 - 49
Company types
Biopharmaceutical company
Primary activities
Biopharmaceutical
Contract Manufacturer
Technology
View company profile
Categories
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Specifications
  • Details
    • Real-time RT-qPCR assay for rapid mycoplasma detection 
    • Detection of both RNA and DNA targets 
    • Detection limit: ≤10 CFU/ml and <100 GC/ml 
    • Detection spectrum: ≥130 Mollicutes species 
    • Suitable for QC release testing of biopharmaceuticals and ATMPs 
    • Compatible with standard qPCR cyclers (FAM™ / HEX™ channels) 
    • USP <63> and USP <77> draft compliant 
    • Time-to-result ≤3 hours 
    • Minimal hands-on time ≤30 minutes 
    • Lyophilized reagents for improved stability and simplified handling 
    • Includes Internal Control and Positive Control
  • Selling Points
    Product Features; Product Performance;
    • Compatible with common qPCR cyclers 
    • Clear result interpretation 
    • Includes Internal and Positive Controls 
    • Optimized for pharmaceutical quality control 
    • Supports NAT-based mycoplasma testing workflows
    • Designed for routine QC and release testing 
    • Suitable for cell cultures and ATMPs 
    • Validation documentation available
  • Model
    RT-qPCR Mycoplasma Detection Kit
  • Supplied from
    Germany
More specifications Fewer specifications

Minerva Biolabs GmbH

  • Country/Region:
    Germany
  • Founded:
    1999
  • On CPHI since:
    2026
  • Certificates:
    1
  • Employees:
    25 - 49
Company types
Biopharmaceutical company
Primary activities
Biopharmaceutical
Contract Manufacturer
Technology
View company profile

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Minerva Biolabs GmbH resources (2)

  • Minerva Biolabs Supports Compliance with the Updated EP 2.6.7 Requirements

    News Minerva Biolabs Supports Compliance with the Updated EP 2.6.7 Requirements

    The revised EP 2.6.7 chapter introduces new expectations for NAT-based mycoplasma testing. With validated PCR assays, extraction kits, and reference standards, Minerva Biolabs offers comprehensive solutions to help laboratories efficiently implement and validate compliant workflows according to the latest European Pharmacopoeia requirements.
    21 May 2026
  • Minerva Biolabs Company Brochure

    Brochure Minerva Biolabs Company Brochure

    Discover Minerva Biolabs’ portfolio of mycoplasma detection and cell culture contamination control solutions for pharmaceutical, biotechnology, and research applications.