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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Great results.
Detection
Very effective product. Directions are clear and it works great.
Review Date: 8 Feb 2021 | Sartorius Group
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:
- Cell culture preparation for best cell health
- Rapid cell culture harvest
- Optimized concentration/diafiltration
- Fast target purification
- One-step particle removal/ sterile filtration
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).
Microbial detection: Solutions for microbiology quality control
The advancement of cellular therapeutics requires complex biological approaches, making it important to confirm cellular viability and identity, product consistency, efficacy/potency and, critically, microbiological safety of released products. However, with growth-based quality control (QC) releases accounting for long time periods, identifying and reducing potential sources of contamination at all stages of the development workflow for advanced therapy medicinal products (ATMPs) is essential. These steps are critical to ensuring product compliance and patient safety.
In this application-based eBook, we look at quantitative polymerase chain reaction (qPCR) applications for microbial detection and show how cutting-edge technologies, such as the Microsart® microbial detection kits from Sartorius, help to deliver smarter tools for microbiological quality control, including:
- Microbial detection procedures and technologies
- Quantitative analysis using PCR-based applications and next-generation sequencing
- Avoiding contamination with reliable pipetting techniques
- Increased accuracy with rapid detect microbial detection kits and guidelines.
