Strict quality inspection is required in the preparation process of biological products to achieve safety and reliability, such as gene therapy products, cell therapy products, biological vaccines, etc. These biological products are mostly prepared or constructed using cells as carriers, and are prone to mycoplasma contamination during the production and preparation process. According to literature reports, the incidence of Mycoplasma contamination in storage cell lines is about 15% -35%, and in the biopharmaceutical industry it is about 0.44% -6.70%. Among these pollution incidents, 95% of the mycoplasma species are the following: oral mycoplasma, arginine mycoplasma, porcine nasal mycoplasma, fermentative mycoplasma, human type mycoplasma, or Leydomonas.
Mycoplasma pollution is like a nightmare for biological preparation companies, not only leading to a decline in product quality; It can also reduce expression levels and ultimately lead to a decrease in production, such as in the CHO DG44 reactor used for antibody production contaminated with Mycoplasma arginine. It was found that side effects began to occur 2-6 days after contamination, leading to a decrease in cell growth rate and changes in DO and pH within the reaction system. At the same time, mycoplasma contamination can also have adverse side effects on patients. The rapid and accurate detection of Mycoplasma is extremely urgent. Currently, the recommended methods for Mycoplasma detection in domestic and foreign pharmacopoeia are mainly based on culture method, NAT (nucleic acid amplification) method, and indicator cell culture method.
After ingenious research and development, a super simple and fast qPCR Mycoplasma detection kit based on the NAT method recommended by the EP Pharmacopoeia has been launched, overcoming the problems of low sensitivity of ordinary PCR and time-consuming cultivation methods, and improving the accuracy and convenience of the results! The Yisheng Biological Mycoplasma qPCR Detection Kit can be used to accurately detect the contamination process and release of Mycoplasma in cells and biological products such as cell seed banks, virus cultivation and harvesting, and clinical treatment purposes. It can quickly and conveniently detect the presence of Mycoplasma within 3 hours, surpassing the 28 day time-consuming detection process of culture method.
Product Features
1.High sensitivity: Mycoplasma standard validation sensitivity reaches 10CFU/mL
Easy to operate: total sample preparation and detection time<3h
2.Good specificity: multiple closely related species verified without cross reactivity
3.Compliance with regulations: The testing method and process are verified in accordance with the requirements of the pharmacopoeia and comply with regulatory requirements
4.Wide applicability: Detects 105 types of Mycoplasma, suitable for various samples (cells, viruses, culture media, cell products, etc.)
High accuracy: probe method detection, avoiding false positives caused by dye method, stable between batches
5.High safety: The standard sample in the reagent kit is non infectious and has good safety