Microsart® ATMP Sterile Release: PCR-Based Rapid Sterility Testing for Short Shelf-Life Products
In the field of cell-based therapies, the Microsart® ATMP Sterile Release Kit stands out as an essential tool for ensuring the safety and efficacy of Advanced Therapy Medicinal Products (ATMPs). This innovative kit allows for the rapid detection of bacterial and fungal contamination within a mere 3 hours, leveraging the accuracy and reliability of real-time PCR technology. By combining the strengths of Microsart® ATMP Bacteria and Microsart® ATMP Fungi, our kit provides a comprehensive solution that is unparalleled in the market.
Key Benefits of the Microsart® ATMP Sterile Release Kit:
Rapid Results: Obtain conclusive evidence of sterility in only 3 hours, a significant improvement over traditional 14-day cultivation methods.
High Specificity: Employ TaqMan® probes for the highest level of qPCR specificity, eliminating the need for ambiguous melting curve analysis and reducing the risk of false positives.
Streamlined Protocol: Our kit simplifies the testing process, reducing pipetting steps with a ready-to-use master mix and providing non-infectious bacterial and fungal validation standards to eliminate contamination risks.
Compliance with Standards: Ensure validated test results that adhere to international quality control standards, safeguarding patient health and regulatory compliance.
Versatility: The kit is designed to be compatible with your existing laboratory equipment, making it easy to integrate into your current workflow without additional investment.
User-Friendly: A step-by-step tutorial for Microsart® ATMP Bacteria ensures a smooth and straightforward testing process, even for users new to the kit.
Customization: Choose the kit that best fits your specific needs, with options tailored to different testing requirements.
The Microsart® ATMP Sterile Release Kit is a commitment to patient safety and the integrity of cell therapy products. By minimizing the need for prophylactic antibiotics and ensuring the release of only contamination-free ATMPs, this kit is an asset for any laboratory dedicated to the advancement of regenerative medicine.
Experience the difference for yourself and take advantage of our offer to request a free trial.