Contamination Control Compass
10CFU® & 100CFU® Mycoplasma Standards

10CFU and 100CFU Mycoplasma Standards now available

Fully aligned with EP 2.6.7 (12.2), USP <77> and JP 18 G3

Mycoplasma contamination remains one of the most critical risks in cell culture systems and biopharmaceutical manufacturing, including ATMPs. With the revision of EP 2.6.7 (12.2) and the introduction of USP <77>, nucleic acid amplification techniques (NAT) now operate within a clearly defined regulatory framework.

Our new 10CFU® and 100CFU® Mycoplasma Standards were developed to fully support these updated regulatory requirements.

Key features:

  • Manufactured from native mycoplasma material

  • Inactivated mycoplasma particles containing ≤10 CFU/ml or ≤100 CFU/ml

  • GC/CFU ratio <10

  • Absolute quantification by digital PCR

  • Lyophilized format improves stability

  • Optimized cultivation with reduced clustering

  • Manufacturing process based on precisely defined master batches

The standards are suitable for method validation, revalidation, and regulatory applications, as well as for quality control and routine testing. They are intended for NAT-based methods, including PCR, qPCR, dPCR and RT-based PCR assays. Due to the defined concentration, no customer-side dilution is required.

Application:

10CFU® Mycoplasma Standards

  • Test for Inhibitory Substances (EP 2.6.7)

  • Method Suitability Test (USP <77>)

  • External positive control at the detection limit

100CFU® Mycoplasma Standards

  • External Positive Control (EPC) close to sensitivity limit for EP 2.6.7

  • Extraction Inhibition Control (EIC) for USP <77>

  • Assay performance evaluation

  • Preliminary tests to detect inhibitions caused by product matrix

Discover 10CFU®
Discover 100CFU®

Prefer working with genome copies instead of CFU?

The revised EP 2.6.7 opens new possibilities – explore our new 100GC® Mycoplasma Standards.

For PCR-based methods, a sensitivity limit of <100 GC/ml has been introduced alongside the existing ≤10 CFU/ml, a PCR-appropriate unit that reflects what molecular laboratories have been using and expecting for years.

All 100GC® Mycoplasma Standards provide non-infectious, quantitative reference materials designed to support product-specific validation.

Key features:

  • RNA-containing DNA standard with 100 GC/vial

  • For product-specific validation and as external positive control

  • Ready-to-use

  • Lyophilized format improves stability

Get 100GC® Mycoplasma Standards
 

You want to order from the US?

Visit our online shop exclusively for our customers from the United States.

Shop standards in US now
 

Informative article

Still confused about the revised EP 2.6.7 requirements?

Minerva Biolabs product packages of 100GC, 10CFU, 100CFU Standards and Venor® Mycoplasma qPCR

Photo PCR: iStock.com | vkovalcik

The updated chapter introduces several important changes that impact mycoplasma testing and existing validation strategies.

In our latest update, we explain:

  • The revised NAT requirements

  • The introduction of the GC/CFU acceptance criterion

  • The key differences between the previous 10CFU®/100CFU® Sensitivity Standards and the new 10CFU®/100CFU® Mycoplasma Standards

We also discuss what these changes mean for existing validations.

Read the full explanation and stay compliant with EP 2.6.7
 

Here's to clean cultures and reliable results!


Warm regards,

Your MB Team

 

Do you need technical support or have questions regarding our products? Please contact support@minerva-biolabs.com. Any feedback or suggestions? Write an email to newsletter@minerva-biolabs.com.

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