References | Transforming mycoplasma testing for faster biotherapeutic quality control

References

1. Zhang D, et al. Rapid and Sensitive Mycoplasma Detection In Antibody Bioprocessing Via RPA-CRISPR/Cas12a’, Journal of Pharmaceutical and Biomedical Analysis. 2025; 263, 116904.

2. EPC Adopts Mycoplasmas General Chapter and Monographs, Updated To Incorporate Latest Analytical Developments. [Internet] European Directorate for the Quality of Medicines & HealthCare (EDQM). 2025. Available from: https://www.edqm.eu/en/-/epc-adopts-mycoplasmas-general-chapter-and-monographs-updated-to-incorporate-latest-analytical-developments

3. Dos Santos S, Lespinasse E, Bonnet B. Basmaciogullari S. Simple, Specific, Rapid, and Pharmacopoeia-Compliant qPCR Approach For The Detection Of Mycoplasma in Biopharmaceuticals. Molecular Therapy – Methods & Clinical Development, 2025;33(3), 101572.

4. Yin R, et al. Development and Validation Of Universal PCR, Basic ERA, and qPCR Assays Targeting the 16S–23S rRNA Intergenic Spacer Region for Mycoplasma detection. Microbial Pathogenesis. 2025; 205, 107669.

5. Houssenaly CK, et al. Strategy for Validation Of New Mycoplasma Nucleic Acid Detection Closed System And It Use In Routine Biopharmaceutical Manufacturing. PDA Journal of Pharmaceutical Science and Technology, 2025; 79(6), 686–693.

6. Guo Y, et al. Establishment of Nucleic Acid Amplification Technology For The Detection of Mycoplasma in Biological Products. Molecules, 2026; 31(11), 1794.