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.

Culture Test on Agar

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

Assay Duration: 28 – 35 days

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

Assay Duration: 7 – 10 days
Sample Requirement: Dependent upon customer supplied product.

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

We understand that no production plant is identical and that every process is unique. Using a combination of practical experience and a scientific approach, we will customize mycoplasma testing methods to meet your specific requirements including scientifically sound data that will be accepted by regulatory authorities around the globe.

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