Minerva Biolabs Supports Compliance with the Updated EP 2.6.7 Requirements
Minerva Biolabs solutions for compliant NAT-based mycoplasma testing according to EP 2.6.7.
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.
The latest revision of EP 2.6.7 introduces significant updates for NAT-based mycoplasma testing in pharmaceutical quality control and bioprocessing applications. The guideline now includes more detailed requirements regarding assay validation, reference materials, sensitivity criteria, and matrix-specific suitability testing.
One of the key changes is the explicit recognition of both CFU-based and genome copy-based reference standards. In addition, assay sensitivity can now be demonstrated either by ≤10 CFU/ml or by <100 GC/ml. The revised chapter also introduces the “test for inhibitory substances,” emphasizing the importance of verifying assay performance directly within the relevant product matrix.
To support laboratories in addressing these evolving regulatory expectations, Minerva Biolabs provides a coordinated portfolio of validated NAT-based mycoplasma testing solutions. The Venor® Mycoplasma PCR product line, together with the Venor® Mycoplasma Extraction kit and the validated 100GC®, 10CFU®, and 100CFU® Mycoplasma Standards, enables reliable implementation of compliant workflows aligned with the updated EP 2.6.7 requirements.
By combining regulatory expertise with high-quality assay solutions, Minerva Biolabs helps customers simplify validation processes, improve workflow reliability, and maintain confidence in routine mycoplasma testing.
