Good news! The Mycoplasma DNA detection kit of Baorui Biotechnology has been filed with the US FDA for DMF Type II

The mycoplasma detection reagent has obtained international compliance certification

On July 14, 2026, the Mycoplasma DNA detection kit (PCR-fluorescence probe method) independently developed and produced by Zhuhai Baorui Biotechnology officially obtained the Class II filing receipt of the US FDA's Master Drug Document (DMF) (DMF Filing Number: 044105).

The successful filing this time marks that the core technical capabilities of Baorui Biotech in the field of biopharmaceutical quality control have been fully in line with international standards, providing another key compliance tool for the global filing of domestic biopharmaceutical enterprises.

Chinese Pharmacopoeia "Mycoplasma Test Method 3301"When conducting mycoplasma tests, both the culture method and the indicator cell culture method should be carried out simultaneously. Other methods recognized by the national drug inspection institution may also be adopted.

European Pharmacopoeia EP 2.6.7Three methods, namely the culture method, the indicator cell culture method, and the nucleic acid amplification method (NAT), are carried out in parallel.

The European Pharmacopoeia is currently the most detailed and highest-threshold pharmacopoeia standard in the biopharmaceutical industry, and it also serves as the core reference basis for international CRO testing, reference substance research and development, and cross-border application.

Key point:

★ Clearly verify 10 mycoplasma strains. The sensitivity of the NAT simultaneous alternative culture method and indicator cell culture method: detection limit ≤10CFU/mL or < 100 GC/mL;

★ Limit the GC/CFU ratio to less than 10 and strictly control the accuracy of detection.

★ It is recommended that when sampling, "cells and supernatant be taken simultaneously as much as possible" to avoid missing the detection of latent intracellular contamination.

★ It is required to conduct the detection of NAT inhibitory substances.

Mycoplasma strains recommended by pharmacopoeias of various countries:

If poultry cells or materials are used or come into contact with during the production process, it should be tested for the presence of Mycoplasma synoviae.

If insect or plant materials are used or come into contact with during the production process, the presence of spiroplasma should be tested.

The 25th edition of the Chinese Pharmacopoeia states that if the cells are insect cells or plant-based materials are used in the cell culture process, spiroplasma testing should be conducted.

Japanese Pharmacopoeia G3-14-170 and United States Pharmacopoeia 63:Three detection methods are provided: culture method, indicator cell culture method, and nucleic acid amplification method (after evaluation, they must be comparable to the first two methods before they can be used as alternative methods).

FDA's "Chemical, Manufacturing and Quality Control (CMC) Industry Guidelines for Investigational New Drug (IND) Applications for Human Gene Therapy"It is proposed that for the master cell bank (MCB), working cell bank (WCB), and production cell matrix, comprehensive identification and detection of exogenous factors should be completed, including mycoplasma detection, and the detection should follow the pharmacopoeia methods or fully validated alternative methods.

ICH Q5D：It is proposed that mycoplasma control should be carried out for raw materials, virus seeds, unprocessed harvest fluids, etc.

Technical Guidelines for Pharmaceutical Research and Evaluation of Immune Cell Therapy Products (Trial)When the volume of test samples is limited or in special circumstances such as the need for rapid release, if the pharmacopoeia methods cannot meet the requirements, it is advisable to consider developing new detection methods for sterility and mycoplasma for release testing. However, these new detection methods should be fully validated.

Key Points for Consideration of Pharmaceutical Research and Application Materials for Clinical Trials of Cell Therapy ProductsThe quality standards for virus and cell vectors should include mycoplasma, etc. Some types of mycoplasma are pathogenic to humans and animals, posing certain biosafety risks. Therefore, mycoplasma testing is also a mandatory project stipulated in the biological products industry.

"Quality Control of Gene Therapy Products"When the detection methods in the pharmacopoeia are limited, specific alternative methods such as fluorescence quantitative PCR can also be considered.

The Drug Master File (DMF for short) is a confidential technical file submitted by enterprises to the US FDA, which comprehensively records the entire set of information including the production site, process flow, quality control, raw material traceability, inspection methods, and stability studies of the product. It is exclusively used by the FDA for retrieving and reviewing new drug application materials. The FDA classifies DMF into five major categories. The one obtained this time is forType II filing for intermediates, active pharmaceutical ingredients and drugs。

The successful filing of DMF type II indicates that the complete set of technical data for the reagent kit has been fully submitted and accepted for archiving by the FDA. When subsequent cooperative pharmaceutical companies conduct IND applications for overseas clinical trials and NDA/ANDA applications for new drug launches, they can directly refer to the DMF file of this kit. The FDA does not need to repeatedly review the methodological data of the test, significantly shortening the overseas registration review cycle and reducing the risk of verification.

Mycoplasma of Baorui BiologyMycoplasma DNA Detection Kit (PCR-Fluorescence Probe Method)Strictly refer to the European Pharmacopoeia EP 2.6.7 and the Japanese Pharmacopoeia JP XVIii. Comprehensive performance verification has been completed in accordance with the relevant requirements of the United States Pharmacopoeia and the Chinese Pharmacopoeia. Its core performance indicators can stand up to authoritative scrutiny:

The detection limit can reach 5 CFU/mL, and the detection ratio of multiple mycoplasma tested strains is 100%.
It fully meets the requirements for mycoplasma detection as an alternative to traditional culture methods or indicator cell methods (DNA staining method), reducing the detection time from several weeks to 1.5 hours.

Through bioinformatics analysis and experimental verification, this kit can cover the DNA sequences of nearly 200 types of mycoplasma, spiroplasma and non-cholestoplasma.
It has no cross-reaction with more than twenty common production cells, engineered bacteria, and the genomes of bacteria and fungi, ensuring the reliability of the test results。

The kit is equipped with internal quality control (IC) and positive and negative quality control, which can effectively monitor the entire process from sample extraction to PCR amplification.
Prevent false negative or false positive results caused by sample inhibition or operational errors。

Deeply engaged in quality control of biopharmaceuticals

Jointly build a global compliance ecosystem for domestic pharmaceutical enterprises!