Mycoplasma Pharmacopoeia Methods
The preparation and quality control of animal cell matrix for the production and testing of biological products shall be carried out in accordance with the requirements of the 2025 edition of the Chinese Pharmacopoeia, General Chapter 3301 Mycoplasma Tests, USP<63> MYCOPLASMA TESTS, and EP 2.6.7 MYCOPLASMAS, and the culture methods and indicator cell culture methods (DNA staining methods) that meet the regulatory requirements shall be provided.
Sterility Test Pharmacopoeia Methods
The sterility tests are conducted according to the requirements of General Chapter 1101, Sterility Test, of the 2025 edition of the Chinese Pharmacopoeia, EP 2.6.1. STERILITY, and USP<71> STERILITY TESTS, providing membrane filtration and direct inoculation methods that meet regulatory requirements. All sterility tests are performed in a Class A isolator, with continuous environmental monitoring throughout the testing process.
01
Suitability Testing
Suitability tests can be performed on various test samples according to regulatory requirements to confirm the suitability of the method for sterility testing of the test sample.
02
Membrane Filtration Method
Utilizing a closed membrane filter, this method can filter large quantities of test samples and effectively address potential microbial growth inhibitors. It is the preferred testing method for filterable test samples.
03
Direct Inoculation Method
Suitable for test samples that cannot be tested using membrane filtration, including non-clarified aqueous solutions such as suspensions, solid test samples, non-water-soluble test samples, and sterile medical devices.
Mycobacterium Pharmacopoeia Methods
The preparation and quality control of animal cell matrix for the production and testing of biological products in accordance with the requirements of EP 2.6.2 MYCOBACTERIA in the 2025 edition of the Chinese Pharmacopoeia were carried out using the culture method to provide mycobacterial testing that meets regulatory requirements.
Mycoplasma rapid method
We offer method validation services for commercially available mycoplasma NAT rapid detection kits, referencing the European Pharmacopoeia (EP 2.6.7) and the United States Pharmacopeia (USP <77>). While supplier kit validation reports can partially replace methodological performance validation, suitability validation on actual samples is still necessary. Therefore, when validating mycoplasma NAT detection methods, we can use supplier kit validation reports as a basis and then perform suitability validation on actual samples.
• As an alternative to direct culture: the NAT method requires a detection rate of ≤10 CFU/mL.
• As an alternative to indicator cell culture: the NAT method requires a detection rate of ≤100 CFU/mL.
Rapid Sterility Testing Methods
Microbiological testing of cell-based products is conducted in accordance with the requirements of EP chapter <2.6.27>, USP chapter <72>, and the 2025 edition of the Chinese Pharmacopoeia 9406 Guidelines for Microbiological Examination. Equipped with bioMérieux BACT/ALERT 3D aseptic rapid testing equipment, it provides aseptic testing that meets regulatory requirements.
Rapid Method for Mycobacteria: Utilizing qPCR fluorescent probe method, specific primers and probes (FAM-labeled) amplify and detect the 16S rRNA coding region in the mycobacterial genome, qualitatively detecting mycobacterial DNA in the sample. It covers more than 100 mycobacterial DNA sequences; the detection is rapid, highly specific, and reliable.