A Rapid and Sensitive Nucleic Acid Amplification Technique for Mycoplasma Screening of Cell Therapy Products

Area of Science:

• Microbiology and Cell Biology
• Biotechnology and Bioprocessing

Background:

• Mycoplasma species contamination poses a significant risk to cell therapy products and recipients.
• Conventional Mycoplasma testing methods are sensitive but require a lengthy 28-day turnaround time, delaying critical treatment decisions.
• Nucleic acid amplification technique (NAT) methods offer a faster and specific alternative for Mycoplasma detection.

Purpose of the Study:

• To develop and qualify a rapid NAT-based assay for Mycoplasma detection.
• To ensure the NAT method meets or exceeds the sensitivity of traditional compendial testing.
• To provide a timely screening tool for clinical cell therapy products.

Main Methods:

• A novel nucleic acid amplification technique (NAT) was developed for Mycoplasma detection.
• The assay was qualified using Mycoplasma species genomic DNA, eliminating the need for live organisms.
• The lower limit of detection was determined and compared against regulatory requirements.

Main Results:

• The developed NAT method demonstrated a lower limit of detection exceeding Health Canada's regulatory requirements.
• The assay provides rapid and specific detection of Mycoplasma contamination.
• The method has been successfully implemented for screening clinical cell therapy products.

Conclusions:

• This NAT-based assay offers a faster and reliable alternative for Mycoplasma testing in cell therapy.
• Qualification using genomic DNA simplifies the testing procedure while maintaining high sensitivity.
• The assay enhances the safety and quality of manufactured cell therapy products.