Mycoplasma DNA Sample Preparation Kit (Magnetic beads)

产品描述（Product Details）

To expedite in-process and lot-release testing, the Mycoplasma DNA Sample Preparation kit based on magnetic beads has been developed, offering a simple and convenient way to isolate mycoplasma DNA from biologic products. All handling and run times are 40-50 minutes.
Combined with Mycoplasma DNA Sample Preparation Kit, ACRO's mycoplasma Rapid Detection kit (OPA-S101, OPA-S102) can sensitively and reliably detect mycoplasma contamination in biological products, meeting or exceeding the regulatory guidance of 10 CFU/mL.

背景（Background）

During the production of biological products (cell isolation, modification, and proliferation), contamination by mycoplasma poses potential risks to patients. Therefore, it is crucial to ensure that the final products are free from mycoplasma contamination during release testing. Traditionally, assessing whether biological products have been contaminated relied on conventional microbiological culture procedures using liquid media and agar media (culture method or indicator cell culture method). However, with the advancement of Biopharmaceuticals and Advanced Therapy Medicinal Products (ATMPs), culture-based methods no longer meet the rapid release requirements.

应用说明（Application）

The kit is used for extraction of mycoplasma DNA in cells and bioproduct media.

For use in quality control/manufacturing process only.

It is for research use only.

优势特色（Features）

1. High recovery: DNA recovery yields superior purity over column-based methods
2. Better robustness: Tolerant to various matrices, high cell density (107 cells/mL), 10% DMSO, T/NK cell mediums, etc.
3. High-quality: This Kit is manufactured in GMP-like facility and alignment with the ISO 13485 standard.

存储（Storage）

This product should be stored at 20-25℃ upon receiving.

组分（Materials Provided）