Get QC Results for Advanced Therapy Medicinal Products (ATMPs) Before Treatment with the Microsart^® ATMP Sterile Release kit

ATMPs are tested using qPCR that detects a broad range of gram-positive and gram-negative bacterial and fungal contaminants.

Avoid lengthy 14-day cultivation protocols and save time. TaqMan^® probes ensure the highest level of qPCR specificity. No need to perform uncertain melting curve analysis.

Validation standards for required bacterial and fungal species in Microsart^® ATMP Sterile Release are lyophilized to render them non-infectious. We provide step-by-step, matrix-specific validation guidance from Sartorius qPCR experts. Avoid the risk of cross-contamination with individually packaged, sample-specific vials.

Microsart^® ATMP Sterile Release kits were developed in close cooperation with authorities, and are validated according to EP 5.1.6 and USP <1223> for sensitivity, specificity, and robustness.

This test is not a replacement for the classic sterility test according to USP<71> or EP 2.6.1.

The ready-to-use master mix has the DNA for internal control already included. Avoid false-negative results and minimize the number of reactions you need to run.

Microsart^® ATMP Sterile Release Kits can be used with any qPCR cycler able to detect the fluorescent dyes FAM^® and ROX^®. Our clear, color-coded reagents guide the user through the short and simple protocol. Lyophilized reagents ensure consistent quality without the need for freezer storage.

Available Kit Options:

1. For testing cell-based theraputics (ATMPs) such as autologous chondrocyte transplants or CART-T cells:

• Microsart^® ATMP Bacteria
• Microsart^® ATMP Fungi
• Microsart^® ATMP Sterile Release (combined kit)

2. For detection of Bacteria and Fungi in R&D cell cultures:

• Microsart^® RESEARCH Bacteria  
• Microsart^® RESEARCH Fungi