Harmonized USP <63> Mycoplasma Test

M-1400 Procedural Summary

Bionique’s M-1400 Harmonized USP Mycoplasma test was designed to comply with USP chapter Mycoplasma Tests, European Pharmacopoeia (Ph. Eur.) chapter 2.6.7 Mycoplasma, and the United States FDA’s 1993 Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (PTC) requirements.

The 28-day culture-based (broth, agar, and indicator cell) method is used to determine the presence or absence of agar-cultivable and non-cultivable mollicutes (mycoplasmas and acholeplasmas) in a test sample. The M-1400 test is intended to satisfy United States and European Union requirements for lot-release mycoplasma testing of unprocessed bulk harvest samples and cell bank samples. Other types of samples subject to regulatory scrutiny or any materials in which mycoplasma contamination is suspected may also be evaluated using this GMP-compliant test.

Note: As required by USP , a qualification study must be performed to test for the presence or absence of inhibitory substances for each product. This qualification study (Cat. No. M-1450) is recommended only once for any given product unless changes within the sample matrix or manufacturing process occur.

Shipping Instructions:

A 15-25mL sample aliquot should be frozen in a sterile 50mL polypropylene centrifuge tube or sterile 40mL Nalgene PETG screw cap bottle.

Place the sample vessel inside a plastic bag with crush proof packaging in an appropriate container. The frozen sample(s) should be shipped overnight in an insulated container with sufficient dry ice to keep frozen for a minimum period of 48 hours.

Please view our general sample submission instructions page for details on how to submit your sample(s) online.

Download Sample Submission Forms
GMP Service
Total Testing Time: 28 days
Sample Requirements: Minimum Test Volume = 15 mL

Specializing In

Real-Time PCR Testing

Bionique has optimized the MycoSEQ Real-Time PCR Detection Assay for mycoplasma testing.

PCR Testing Services Harmonized USP Testing