The global bioburden testing market for bio-pharma contamination is approximately $10B, with over 350M tests run annually. LexaGene provides early detection for mycoplasma, aiding in validating product quality for biopharmaceutical manufacturers.
Biomanufacturing is a type of biotechnology used to commercialize products such as vaccines, antigen treatments, and gene therapy. Cell-based growth occurs in highly sterile, bulk quantity conditions but has a high risk of contamination which can be introduced in multiple steps of the complex processes.
Mycoplasma Contamination Concerns
A single contamination event can cost millions of dollars, halt processes, require the disposal of all contaminated product, shut plants down, and delay shipment of critical pharmaceuticals.
Testing and Market Size
The need for testing is critical, and national and international regulatory groups impose strict regulations on acceptable microbial limits. Bioburden testing is frequently done on raw materials, in -process testing, the final product, and the manufacturing environment.
The global bioburden testing market for bio-pharma contamination is approximately $10B, with over 350M tests run annually.
Contaminant Culprits Include Mycoplasma
Typical contaminants include bacteria, viruses, and fungi. Common human transmitted bacteria include C. Acnes, viruses, and single cell fungi. A bacterium that is particularly difficult to detect and eliminate in the cell growth line are the genus Mycoplasma. These are organisms without a cell wall and are so small that they evade the standard inline 0.1 um sterile filtration, unlike E. Coli which are almost 10 x larger. Detection of these bacteria is also challenging due to their natural prevalence, slow growth rate, and limited effect on optical turbidity.1 It is thought that the incidence rate of mycoplasma in cell lines is between 15-35%. The majority of detected mycoplasma include M.orale, M. arginigni, and M. fermentans.
How Does Testing Work?
Accurate identification of mycoplasma is typically done offline, is time consuming, and requires highly specialized facilities and personnel.
Standard culture testing can take up to 2 weeks to grow sufficient bacterial colonies so trained personnel can optically identify a particular bacterium. In addition to culturing bacteria on an agar plate, intricate lab techniques require enrichment of the liquid broth, staining and fluorescence labeling. While this complex process is reliable, it is also time consuming and exceptionally manual.
The value of nucleic acid or genetic based testing methods such as qPCR are beginning to be recognized by leading edge testing specialists. Although providing a much faster time to answer than culture, classical PCR requires highly specialized facilities and skilled personnel to interpret the results.
MiQLab™ and PCR Can Help
LexaGene’s MiQLab is a commercialized, bench top PCR system that offers:
- Fully automated identification of multiple pathogens from a single sample
- At line testing in any bioprocessing site
- Rapid turnaround time to answer in ~2 hours
Thus, changes to a process can be made 360 x faster than waiting for culture results, reducing contamination risk. Testing costs can also be reduced since the automated system does not require specialized facilities or trained personnel to analyze and interpret the data.
Recent MiQLab Test Data
In a recent LexaGene study, a mycoplasma PCR test was designed to detect 5 common species of mycoplasma, including M. arginine and M. fermentans. Standard incubation of these cells was compared to the same samples run on MiQLab. The MiQLab successfully detected 3 species with a 100% detection rate. The other species were not detected because they were outside the threshold parameter ranges for both methods.
This study shows that MiQLab is a valid alternative to lengthy culture methods for mycoplasma detection. MiQLab is up to 300 times faster than traditional culture (2 hrs. vs 28 days) and has a very high specificity rate.
Learn more about how MiQLab can provide rapid, at-line, detection for mycoplasma, aiding in validating product quality for biopharmaceutical manufacturers.
Download LexaGene’s Application Note “Rapid Detection of Mycoplasmas, A Common Bioreactor Contaminant, Using MiQLab™ Mycoplasma Test.”