Roadmap to Implementation of a Rapid "Lab in a Pouch" NAT Method for Mycoplasma Testing.

Abstract

Mycoplasma testing is a mandatory assay for all cell-derived products as part of the microbial control strategy. The compendial methods include an indicator cell culture method and a culture assay. Because the culture assay takes 28 days, the time-to-result (TTR) is one of the longest in the microbiology laboratory. Besides this, the compendial Mycoplasma methods are highly complex, subjective, and need strict segregation of labs to avoid cross-contamination with Mycoplasma. The pharmaceutical industry is seeking faster solutions, like nucleic acid testing (NAT)-based methods. There are alternative and rapid NAT methods on the market enabling a reduction of the TTR to approximately 1 day (1). Although some of these NAT methods offer partial automated solutions (e.g., nucleic acid extraction), many of them still require strict separation of test areas to avoid false-positive results and provide only limited hands-on-time reduction and simplification. In contrast, the BioFire® Filmarray® technology is a NAT method that is easy to use thanks to a closed process-a so called "lab in a pouch"-and provides the result within only 2 hours, including sample preparation. Besides the risk reduction of human errors due to the limited manual work involved, the automation can also lead to improved data integrity compared to the compendial method. This paper describes the roadmap of implementation of the BioFire^® Filmarray^® technology. The approach from feasibility studies to validation and regulatory submission for a monoclonal antibody (mAb)-based product is provided. As a first, J&J received regulatory approval from several agencies (including the US FDA and the EMA) to apply this technology for a biopharmaceutical product and has started global roll-out to additional products and testing sites. Understanding the risk concomitant with introducing new methods is essential to develop an appropriate validation, implementation, and filing strategy. The process applied at J&J for the first product will be shared in this publication.