Contamination Control Compass
Edition #05/2026

 

Regulatory Updates
USP <77> becomes official on October 1, 2026 – be ready with validated mycoplasma testing solutions

Photo of a person setting tubes in a PCR cycler

Photo: iStock.com | vkovalcik

With USP <77> Mycoplasma Nucleic Acid Amplification Tests becoming official on October 1, 2026, laboratories using molecular methods for mycoplasma detection will have a dedicated USP chapter for the validation and application of nucleic acid amplification techniques (NATs). USP <77> specifically addresses NAT-based mycoplasma testing for biotechnological products and cell-based materials, complementing the existing USP <63> framework with more targeted guidance for molecular assays.

For users, this means a stronger regulatory focus on validated NAT workflows, suitable controls and method suitability. Defined standards and controls will therefore become even more important for demonstrating assay performance and regulatory readiness.

Minerva Biolabs supports this transition with a dedicated portfolio of mycoplasma detection kits and standards. Our Venor® Mycoplasma qPCR, together with 100GC®, 10CFU®, and 100CFU® Mycoplasma Standards provide reliable solutions for NAT-based mycoplasma testing.

Whether you are preparing for USP <77>, aligning with revised EP 2.6.7 (12.2) requirements, or updating your internal quality control strategy, our products help you implement sensitive, robust, and regulation-ready mycoplasma testing workflows.

 

Meet us at LAB-SUPPLY Berlin

We will be exhibiting at LAB-SUPPLY Berlin on June 16, 2026 – the trade fair for the latest laboratory technologies, applications and equipment. We will answer all your questions about reliable solutions for contamination control.

Admission is free. We look forward to your visit!

 
Logo CPHI Shanghai Trade Fair

Meet us at CPHI China 2026

From contamination control to reliable mycoplasma testing, quality requirements in biopharma manufacturing continue to grow worldwide.

At CPHI China from June 16–19 in Shanghai, we look forward to discussing practical solutions for regulated workflows, ATMPs and QC challenges with you.

If you are attending, stop by and exchange ideas with our team.

 

Product Highlights
New USP <77> and EP 2.6.7 Update: New era for PCR-based mycoplasma testing

Photo of 100GC® Mycoplasma Standard packaging

The new USP <77> and the revised EP 2.6.7 (12.2) open up new possibilities for PCR-based mycoplasma testing. For PCR-based methods, a sensitivity limit of <100 genome copies (GC)/ml has now been introduced alongside the established requirement of ≤10 CFU/ml.


Genome copies are a PCR-appropriate unit that reflects the expectations of molecular laboratories and supports a more practical approach to method validation.


Our 100GC® Mycoplasma Standards are purified nucleic acid standards designed to support product-specific validation. They are available for 10 relevant mycoplasma species.

Key features:

  • Derived from native mycoplasma material

  • Non-infectious

  • Suitable for product-specific validation and use as an external positive control

  • Quantified by digital PCR

Discover 100GC® Mycoplasma Standards

Still relying on CFU-based reference material?

Discover our new 10CFU® Mycoplasma Standards – designed to support your validation needs in line with established CFU-based requirements.

 
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QUICK TIP

Separate PCR work areas

Strictly separate clean PCR setup areas from areas handling material containing target nucleic acids. Dedicated protective clothing, equipment and a one-way workflow help reduce carryover contamination.

 

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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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