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Optimized PCR-based Detection of Mycoplasma
Published on: June 20, 2011
54.2K
Roadmap to Implementation of a Rapid "Lab in a Pouch" NAT Method for Mycoplasma Testing.
Philip Breugelmans1, Karen de Roy1, Orm Nieuwenhuizen2
1Janssen Pharmaceutica NV, a Johnson & Johnson company, Turnhoutseweg 30, 2340 Beerse, Belgium.
PDA Journal of Pharmaceutical Science and Technology
|August 29, 2025
Summary
Mycoplasma testing is mandatory for cell products. A new, rapid nucleic acid test (NAT) method significantly reduces testing time from 28 days to 2 hours, improving accuracy and efficiency in microbial control.
Area of Science:
- Microbiology
- Biotechnology
- Pharmaceutical Science
Background:
- Mycoplasma testing is critical for cell-derived products.
- Compendial methods are time-consuming (28 days TTR), complex, and subjective.
- There's a need for faster, more reliable Mycoplasma testing solutions.
Purpose of the Study:
- To describe the implementation roadmap of the BioFire® Filmarray® technology for Mycoplasma testing.
- To detail the validation and regulatory submission process for a mAb-based product.
- To share the experience of J&J in implementing this novel NAT method.
Main Methods:
- Utilized the BioFire® Filmarray® technology, a closed "lab in a pouch" NAT system.
- Conducted feasibility studies, validation, and regulatory submissions.
- Implemented a comprehensive risk assessment for method introduction.
Main Results:
- Achieved a drastically reduced TTR of approximately 2 hours.
- Demonstrated ease of use, reduced manual work, and improved data integrity.
- Received regulatory approval from FDA and EMA for biopharmaceutical product testing.
Conclusions:
- The BioFire® Filmarray® technology offers a rapid, automated, and reliable alternative to compendial Mycoplasma testing.
- Successful implementation and regulatory approval pave the way for broader adoption.
- This technology enhances microbial control strategies in the pharmaceutical industry.
