Mycoplasma Release Testing Cell and Gene Therapy Product Samples Containing Cells in 1 Hour using a Closed-System Next Gen PCR

Introduction

Testing for mycoplasma contamination is a required release test for Cell & Gene Therapy (CGT) products as specified in the major pharmacopeias(1-3). Current compendial methods require ≥ 28 days to generate results and are not suitable for short shelf-life products. Alternative nucleic acid test (NAT) methods are available and can reduce the time to result to hours instead of days.

The BIOFIRE® Mycoplasma test is a closed system sample-to-answer presence/absence NAT that is designed to detect over 130 mycoplasma  species in less than an hour. It requires minimal hands-on time and contains everything needed to run a molecular test. A closed system NAT lowers the risk of contamination and answers the needs of CGT manufacturers for a fast & easy Mycoplasma release test.

Currently, a double centrifugation sample preparation protocol (Figure 3A) has been validated as a release test following current regulatory guidelines with a Limit Of Detection (LOD) of ≤ 10 CFU/mL(4). Although, this protocol is compatible with a wide range of Bioproduction and CGT matrices(5), it  excludes mammalian cells and therefore does not align with the new draft European pharmacopeia (EP) guideline(6).