Microbial Assay Method Development and Method Validation

Microbial assay is one of the basic components of drug safety, which is of great significance in both theoretical research and production practice. Due to the variability of the microbial assay itself, such as sampling error, dilution error, operating error, culture error and counting error in the microbial assay method, as well as the uneven distribution of microorganisms in the test sample, microbial assay method development and method validation is more complicated than that of the physical and chemical method development and method validation.

CD Formulation has experienced analysis experts who can work with our formulation and manufacturing team to help you efficiently and quickly establish microbial assay methods and methods validation.

Our Services

CD Formulation provides analytical method development for microbiological assays as well as method validation services. Based on our extensive experience and experimental instrumentation, our pharmacologists and chemists perform microbial assay development, followed by method validation to ensure the accuracy of analytical assay results.

Microbiological assay method development

We provide method development for qualitative and quantitative microbial assays to determine the presence and quantity of microorganisms in drugs, and provide a method development report to our clients.

• Detection technologies based on microbial growth information, such as bioluminescence technology, electrochemical technology, turbidimetry.
• Direct detection of viable bacteria in samples, such as solid-phase cytometry, flow cytometry.
• Analysis technology based on specific components contained in microbial cells, such as fatty acid determination technology, nucleic acid amplification technology, gene fingerprint analysis technology.

Compared with traditional microbial assay methods, these methods are simple and fast, and have real-time or near real-time monitoring. At the same time, the use of these new technologies also promotes the reduction of production costs and the improvement of inspection levels.

Microbial assay method validation

CD Formulation provides validation services for microbial assay method development and provides you with the relevant validation report.

• Qualitative test method validation.
• Specificity, detection line, durability, reproducibility.
• Quantitative test method validation.

Accuracy, precision, specificity, limit of quantitation, linearity, range, robustness, reproducibility.

If you have a requirement about microbial assay method development and method validation, please contact us by phone or email, our colleagues will reply to you within three working days.