Mycoplasma Testing

Study Design

Assay consists of a culture method and an indicator cell test. Validation of the method using 6 strains is performed as part of the assay. Assay controls are selected according to product type, manufacturing process and customers’ specific needs. Both test methods meet the regulatory requirements listed under regulatory compliance.

• Data Sheet

Culture Test on Agar

• Inoculation in broth and agar media broth
• Several readings and sub-passages
• Incubation at 2 conditions

Cell Culture Method Using Indicator Cell

• Inoculation on indicator cell lines
• Detection of mycoplasma in cell culture by DNA fluorescence staining
• Examination for extra-nuclear fluorescence for mycoplasma

Regulatory Compliance

• EP 2.6.7 European Pharmacopoeia (2.6.7 Mycoplasmas)
• American guideline 21 CFR 610.30 Code of Federal Regulations 21 CFR Ch.1 (4-4-01 edition) § 610.30 Subpart D-mycoplasma
• Center for Biologicals Evaluation and Research, FDA, Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals.

Custom Assays