Microsart® ATMP Mycoplasma
Especially designed for an easy and fast detection of mycoplasma in cell-based therapeutics like autologous chondrocyte transplants (ATMPs –advanced therapy medical products). Due to the short shelf life of these therapeutics, a fast result is needed. The PCR-technology makes it possible to reduce the time-to-result to only 3 hours.
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A fast detection of Mycoplasma contamination in Advanced Therapy Medicinal Products (ATMP) is very important due to the short shelf life of this type of product. With the use of the Microsart® ATMP Mycoplasma the testing time can be reduced from weeks to just 3 hours. Additionally, the utilization of a TaqMan® probe adds high specificity to the PCR system and minimizes the result interpretation. The Microsart® ATMP Mycoplasma has been effectively validated according EP 2.6.7 in combination with EP 2.6.21 with respect to the detection limit for all listed Mycoplasma species, specificity and robustness for autologous cell transplants (e.g. chondrocytes).
The Microsart® ATMP Mycoplasma kit can be easily implemented because no specific hardware is needed.
The kit can be used with any type of real-time PCR cycler able to detect the fluorescence dyes FAM™ and ROX™. The kit contains all essential components in a function tested ready-to-use master mix including the polymerase.
- Fast results within 3 hours
- Easy to use
- Validated according EP 2.6.7 for ATMP`s
Brochures
High-throughput and essential lab tools to streamline cell line development
Everyday lab essential products play a critical foundational role in the success of cell line development and are invaluable to lab technicians and scientists. Basic tasks like pipetting, filtration, and purification of small volumes can be time-consuming and tedious. In this brochure, discover how Sartorius´ lab essentials can help streamline routine tasks and achieve more accurate results. These lab essentials tools are designed to improve result accuracy by increasing reproducibility, avoiding contamination, and increasing safety with ergonomic and easy-to-use products.
Lab equipment essentials for successful cell line development
Successful commercialization of a biopharmaceutical product is dependent upon an effective, high-quality cell line development process. While high throughput analytical instruments often take center stage, everyday lab essentials also play a critical role in creating the stable, high-producer cell lines needed for commercial manufacturing.
This guide will introduce you to lab essentials designed to help streamline routine cell line development tasks. Learn how to achieve more accurate results, avoid contamination, and simplify workflows with reliable and easy-to-use products.
Download this eBook to discover solutions for:
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Benchmarking of two mycoplasma real-time PCR kits suitable for release testing according EP 2.6.7
In this application note, Sartorius compares the capabilities of two different qPCR kits for the detection of Mycoplasma, namely, the Sartorius Microsart® ATMP Mycoplasma qPCR kit and the CellSafe MycoQSearchTM qPCR kit. The EP 2.6.7 required sensitivity of 10 CFU / mL of selective species is tested using three different Sartorius Microsart® Validation Standards (Acholeplasma laidlawii, Mycoplasma orale, Mycoplasma pneumoniae) and one CellSafe Standard (Mycoplasma arginini). Despite some differences in the overall qPCR performance between the benchmarked products, mainly the different shipping conditions and the number of pipetting steps are crucial. The Sartorius qPCR kit shows a higher sensitivity (detected 16 / 16 positive) than the CellSafe qPCR kit (detected 12 / 16 positive).
