A Comparative Performance Study of Adjusted BACT/ALERT^® iFA Plus for Growth Promotion and Antimicrobial Neutralization

2021 PDA Pharmaceutical Microbiology Conference, October 4-6, 2021 – Virtual Meeting

Introduction

Automated culture systems are widely used for rapid-real-time microbial contamination detection for pharmaceutical products including small molecule, bioproduction, and cell and gene therapy (CAGT)1,2,3. CAGT manufacturers have widely adopted automated growth-based technologies as an alternative to the compendial USP

<71> sterility test or by following the compendial EP 2.6.27 that includes automated growth-based methods for detection of contaminating microorganisms4,5. These therapies may contain residual antimicrobials from cell culture media, biopsy and tissue transport media, and cryoprotectants to mitigate contamination. The BACT/ALERT^® 3D (BTA) Microbial Detection System provides an automated non-destructive growth-based rapid microbial alternative to the 14-day traditional test method and is capable of detecting a variety of aerobic and anaerobic microorganisms including fungi6. The BTA method utilizes direct inoculation of ≤ 10 mL of product into

the BTA culture bottle consisting of supplemented Tryptic Soy Broth along with atmospheric conditions required for aerobic or anaerobic growth. The BTA culture bottles are available standard and with resin to neutralize residual antibiotics present in the sample.

The BACT/ALERT^® iFA Plus (BTA iFA Plus) is a neutralizing culture medium used with the BACT/ALERT^® 3D as an non-destructive rapid microbiological method. The iFA Plus medium was recently adjusted through the addition of trace elements to extend shelf-life from 10 months to 12 months from manufacturing date; and achieve a faster time-to-detection (TTD) for specific Candida species.