What is changing in mycoplasma testing Pharmacopeial guidance?

Recent updates to Ph. Eur. 2.6.7 and USP <77> clarify expectations for NAT validation, including full workflow performance, control strategy, and fit-for-purpose validation design.

Is NAT required for mycoplasma testing?

No—but it is increasingly accepted and widely used as a primary method when properly validated, especially in time-sensitive workflows.

What does “fit-for-purpose validation” actually mean?

It means proving the method performs reliably within its intended use conditions and sample matrices—not simply showing it matches culture-based methods one-to-one.

Why are controls receiving more attention now?

Because regulators are placing greater emphasis on demonstrating consistent assay performance and reliable results across the full workflow. Controls are basically the “receipts” of your validation strategy.

Life in the Lab

Company
This field is for validation purposes and should be left unchanged.
First Name
Last Name
Email*
Company
Select your country/region*
Pick a category*
*
- I would like to receive information about content, events, products, services and promotions from Thermo Fisher Scientific and its affiliates. I agree for the Thermo Fisher Scientific group (thermofisher.com/legalentities) to contact me by email and/or telephone to inform me of events, products, services and/or promotions offered in connection with the brands Thermo Scientific™, Applied Biosystems™, Invitrogen™, Gibco™, Ion Torrent ™, Unity Lab Services™, Fisher Scientifc™. I can withdraw my consent and unsubscribe at any time by emailing reply@thermofisher.com By submitting my data, I give consent to the collection, processing and use of my personal data in accordance with the Thermo Fisher Scientific Policy (thermofisher.com/privacypolicy).

What’s Changing in Mycoplasma Testing: NAT, Ph. Eur. 2.6.7, an...

Multiomics Workflow: How to Extract Protein, DNA and RNA from th...

From Gene Editing to Cell Elimination: How Cas12a2 Is Changing C...

How Can Biomanufacturers Actively Reduce Particulate Burden in T...

Beyond Protein A: Improving purification strategies for misbehav...

Single-Use Bioprocessing Sustainability: Reducing Carbon Footpri...

How incubator shakers support recombinant protein expression and...

20 Years of HyPerforma Single-Use Bioreactors: The People and Id...

PDAC Organoids: Advancing 3D Cancer Models at the Yeh Lab

When Bioinformatics Is the Bottleneck: Enabling Complex Viral An...