Mycoplasma detection and elimination is critical for biologicals produced for clinical investigation and as licensed therapeutics including:
• Monoclonal Antibodies
• Viral vaccines (live and inactivated)
• Recombinant Proteins
BioReliance research professionals have performed thousands of mycoplasma detection tests for clients in Biopharma under cGMP and validated to current ICH guidelines. We have recently updated our mycoplasma detection assays to meet or exceed USP, EP, and PTC standards including USP <63>.
The combined assay includes optimal:
• Mycoplasma growth conditions
• Growth media
• Incubation conditions
• Sub-culture schedule
• Indicator cells for non-cultivable mycoplasma
Our methods and CRO technicians ensure fast turnaround time and the highest quality testing to produce biological therapeutics that are contamination free and safe for use in humans.
Download our USP 63 Mycoplasma White Paper to learn more about the details of how this regulation effects your therapeutic production process.
To find the mycoplasma detection assay you need, use the search tool to the right or click here.
What types of assays are used for mycoplasma detection?
Mycoplasma contamination in a cell line is difficult to detect and are not visible to standard microscopy, even at very high concentrations. Further, they do not cause typical contamination changes to growth media.
BioReliance offers a variety of mycoplasma assays:
• Agar and semi-solid broth methods
• Detection of both cell dependent and cell associated mycoplasma
• Indicator cell lines
• Quantitative PCR
These assays offer a wide detection range for a large number of mycoplasma species. Our experts can consult with your team to help determine the methods and criteria required by various regulatory agencies including positive control selection, recovery and inoculum volume.
To see a full list of mycoplasma detection assays use the search tool to the right or click here.
What effects can mycoplasma contamination have on a cell?
Mycoplasma are very small bacteria that do not have a cell wall. They are found in all varieties of organisms from plants to human cells. It has been suggested that a large percentage of continuous cell lines are contaminated with mycoplasma. Once one plate is contaminated, it quickly spreads to other cell lines by cross-contamination.
Mycoplasma contamination can have a drastic effect on cellular processes including:
• Altered gene expression
Mycoplasma can also infect humans causing various diseases including atypical pneumonia. Mycoplasma detection testing can avoid the production of a contaminated and unsafe biological. Mycoplasma free cell cultures make for reliable manufacturing and production of therapeutics.
• Inhibition of cell growth
• Cell death
• Reduced transfection efficiency
• Virus production rates